Sintilimab (Tyvyt)
A PD-1 immune checkpoint inhibitor approved for 10 cancer types in China, including lymphoma, lung, liver, and gastric cancers.
What is Sintilimab?
What it targets
PD-1 on T cells, allowing immune recognition of cancer cells expressing PD-L1. Particularly effective in cancers with high immune cell infiltration.
Who it may help
Patients with specific cancer types approved in China, including relapsed/refractory Hodgkin lymphoma, advanced NSCLC, hepatocellular carcinoma, gastric cancer, and several other malignancies.
Why testing matters
Molecular and histological confirmation of cancer type, stage, and prior treatment history guide eligibility. PD-L1 testing may inform treatment decisions for some indications.
Which cancers can Sintilimab treat?
Sintilimab is approved by China NMPA for the following 10 cancer indications. Use depends on cancer type, disease stage, prior treatment, and your oncologist's assessment.
| Classical Hodgkin Lymphoma | Approved for relapsed/refractory disease after 2+ lines of chemotherapy. Strong response rates; considered standard of care in China. |
| Non-small Cell Lung Cancer (NSCLC) | Approved first-line and for progression after EGFR-TKI in EGFR-mutant disease. Often combined with chemotherapy or bevacizumab. |
| Squamous NSCLC (Second-line) | Approved as monotherapy for disease progression after platinum-based chemotherapy. Phase 3 study met primary endpoint. |
| Hepatocellular Carcinoma | Approved first-line with bevacizumab biosimilar for unresectable or advanced HCC. Median OS improvement over single-agent bevacizumab. |
| Gastric/Gastroesophageal Junction Cancer | Approved first-line with fluorouracil + platinum chemotherapy for unresectable, locally advanced, or metastatic disease. |
| Esophageal Squamous Cell Carcinoma | Approved with chemotherapy for locally advanced or metastatic disease. Phase 2/3 data show improved survival. |
| Endometrial Cancer | Conditionally approved (December 2024) with fruquintinib for pMMR tumours with prior systemic therapy failure. |
| Renal Cell Carcinoma | Approved (May 2026) with fruquintinib for advanced/metastatic RCC. Median PFS 22.2 months vs 6.9 months with standard therapy. |
| Colorectal Cancer | Approved (May 2026) with ipilimumab N01 as neoadjuvant for MSI-H/dMMR resectable disease. 82% pathological complete response rate. |
| Natural Killer/T Cell Lymphoma | Early-phase data suggest benefit in select subtypes; continued clinical investigation in China and internationally. |
Are you eligible for Sintilimab?
Eligibility depends on confirmed cancer diagnosis, disease stage, prior treatment history, organ function, and whether sintilimab is approved for your specific cancer type in your country.
- Confirmed histological or pathological diagnosis of a cancer type approved for sintilimab in China.
- For relapsed/refractory Hodgkin lymphoma: prior 2+ lines of systemic chemotherapy.
- For solid tumours: unresectable, locally advanced, or metastatic disease, or treatment-naive disease eligible for first-line immunotherapy.
- Adequate liver function (typically bilirubin and transaminases <3x upper limit of normal).
- Adequate kidney function (typically creatinine clearance >30 mL/min).
- Adequate blood counts (haemoglobin >8 g/dL, neutrophils >1000/μL, platelets >50,000/μL; adjusted for combination therapies).
- No active, uncontrolled infection or serious underlying organ disease.
- No pregnancy, plan to use effective contraception, no active breastfeeding.
- Performance status suitable for immunotherapy (generally ECOG 0-1, rarely ECOG 2 with oncologist approval).
How does Sintilimab work?
- Blocks PD-1 checkpoint
- Removes immune brake
- Reactivates T cell response
- Tumor shrinkage and control
Unlike chemotherapy, sintilimab does not directly kill cancer cells but mobilizes your own immune system to do so.
Tests required before starting Sintilimab
These tests establish your baseline health, confirm eligibility, and guide treatment decisions and monitoring.
| Histopathology | Confirms cancer type and stage. Biopsy samples may be used for PD-L1 testing and other biomarkers. |
| Complete Blood Count (CBC) | Baseline haemoglobin, white blood cell count, and platelets; monitored during treatment to detect bone marrow effects. |
| Liver Function Tests | Bilirubin, ALT, AST, alkaline phosphatase. Critical because sintilimab can cause immune-related hepatitis. |
| Kidney Function Tests | Creatinine and estimated GFR. Sintilimab can rarely cause immune-mediated nephritis; dosing depends on renal function. |
| Thyroid Function Tests | TSH and free T4. Sintilimab can trigger thyroiditis or hypothyroidism; baseline is essential for monitoring. |
| Glucose and Electrolytes | Baseline glucose, sodium, potassium; immune-related effects on pancreas and adrenal glands are possible. |
| HIV, Hepatitis B, Hepatitis C | Sintilimab is relatively contraindicated in active HBV/HCV; testing guides eligibility and monitoring strategy. |
| Imaging (CT/MRI/PET-CT) | Establishes baseline tumour burden and location; essential for response assessment during and after treatment. |
| Pregnancy test | For women of childbearing age, to exclude pregnancy before treatment initiation. |
| Autoimmune disease screening | History of lupus, rheumatoid arthritis, IBD, or other autoimmune disease increases risk of severe immune-related toxicity. |
How is Sintilimab given?
Sintilimab is administered as an intravenous infusion at a hospital or specialist oncology centre. The exact dose, schedule, and combination partner depend on your cancer type and treatment plan.
| Standard dose (most indications) | 200 mg once every 3 weeks as an IV infusion over 30-60 minutes. |
| Dose for combination therapy | When combined with chemotherapy or bevacizumab, 200 mg on the same day as the partner drug, once every 3 weeks. |
| Administration | IV infusion at a hospital, cancer centre, or infusion clinic under medical supervision. Pre-treatment hydration and antihistamines may be given. |
| Infusion duration | Typically 30-60 minutes depending on tolerance and institutional protocol; can be adjusted for individual reactions. |
| Monitoring during infusion | Your oncology team monitors blood pressure, heart rate, temperature, and oxygen saturation. Report any chills, fever, shortness of breath, or dizziness immediately. |
| Duration of therapy | Treatment continues until disease progression, unacceptable toxicity, or completion of a planned treatment course. Some patients continue for 1-2 years. |
Clinical evidence and benefits
Sintilimab has demonstrated clinically meaningful benefits in 10 cancer types across multiple landmark trials and real-world studies in China.
| Hodgkin lymphoma response | Objective response rate >70% in relapsed/refractory disease; majority of responders have durable remission (>1 year). |
| NSCLC survival improvement | First-line sintilimab + chemotherapy significantly improves progression-free and overall survival vs chemotherapy alone. |
| HCC progression-free survival | Sintilimab + bevacizumab provides median PFS of 10+ months, substantially longer than single-agent bevacizumab. |
| Gastric cancer efficacy | First-line combination regimen improves overall survival and disease control vs chemotherapy alone. |
| Esophageal cancer outcome | Combination with chemotherapy improves response rates and median overall survival vs chemotherapy monotherapy. |
| RCC efficacy (recent) | Sintilimab + fruquintinib achieves median PFS of 22.2 months, a 63% reduction in progression/death risk vs standard therapy. |
| Colon cancer pathological response | Neoadjuvant sintilimab + ipilimumab achieves 82% pathological complete response in MSI-H/dMMR stage IIB-III disease. |
| Durable responses | Significant proportion of responders maintain benefit for 2+ years, with some long-term remissions reported. |
Individual responses vary significantly. These benefits represent published trial data and reflect outcomes in patients meeting trial eligibility. Your personal benefit depends on cancer characteristics, prior treatment, and overall health.
Side effects of Sintilimab
Sintilimab activates the immune system, which can cause inflammation in normal organs. Most side effects are manageable with medical support, and the severity profile is typically more favourable than chemotherapy.
| Fatigue or weakness | Very common; usually mild to moderate. Managed with rest, exercise, and nutritional support. Severe fatigue warrants investigation for thyroid or adrenal involvement. |
| Rash or itching | Common skin reactions ranging from mild urticaria to severe dermatitis. Managed with topical or systemic steroids depending on severity. |
| Diarrhea | Common; ranges from loose stools to severe colitis. Mild cases respond to dietary modification; severe cases require steroids and GI evaluation. |
| Nausea and vomiting | Less common and usually milder than with chemotherapy. Anti-nausea medications are effective; often resolves after first few infusions. |
| Cough or shortness of breath | Can signal pneumonitis (lung inflammation), a serious immune-related toxicity. Any respiratory symptoms warrant urgent evaluation. |
| Elevated liver enzymes | Detected on blood tests; ranges from asymptomatic elevation to severe hepatitis. Regular monitoring is essential; steroids reverse most cases. |
| Thyroid dysfunction | Can develop as hypothyroidism or hyperthyroidism. Managed with thyroid hormone replacement or antithyroid drugs. Baseline and regular TSH monitoring required. |
| Joint or muscle pain | Can occur weeks into treatment. Usually mild; managed with analgesics and non-steroidal anti-inflammatories where appropriate. |
Contact your doctor immediately if you develop:
- Severe or worsening cough, chest pain, or shortness of breath — may indicate pneumonitis.
- Severe diarrhea (>4 loose stools daily), blood in stool, or severe abdominal pain — may indicate colitis.
- Yellow eyes, dark urine, right upper abdominal pain, or severe nausea — may indicate hepatitis.
- New headache, vision changes, confusion, fainting, or extreme fatigue — may indicate endocrine dysfunction or neurological toxicity.
- Fever >38.5°C, chills, sore throat, or signs of infection — sintilimab increases infection risk despite immune activation.
Safety precautions and drug interactions
Tell your oncologist and pharmacist about all medicines, supplements, and herbal products. Sintilimab has fewer interactions than some targeted therapies, but certain medications require caution.
- Autoimmune disease (lupus, rheumatoid arthritis, IBD, psoriasis): sintilimab can trigger severe flares. Discuss with your oncologist before starting.
- Prior organ transplant or stem cell transplant: sintilimab can cause graft rejection or graft-versus-host disease. Usually contraindicated.
- Lung disease (asthma, COPD, interstitial lung disease): sintilimab increases pneumonitis risk. Baseline pulmonary function tests may be needed.
- Liver disease or hepatitis B/C: sintilimab can cause hepatitis. Active HBV requires antiviral therapy; HCV requires careful monitoring.
- Diabetes: sintilimab can worsen glucose control or trigger new-onset diabetes. Blood glucose monitoring essential.
- Thyroid disease: sintilimab frequently triggers thyroiditis or hypothyroidism. Baseline TSH and regular monitoring required.
- Live vaccines: avoid during and for several weeks after sintilimab. Inactivated vaccines are safe but may be less effective.
- Immunosuppressant drugs: concurrent use can blunt sintilimab efficacy. Discuss with oncologist before continuing systemic corticosteroids or other immunosuppressants.
- Pregnancy and breastfeeding: sintilimab is absolutely contraindicated. Effective contraception required throughout treatment and for some time after.
Sintilimab combination treatments
Sintilimab is used as monotherapy in some settings and combined with chemotherapy, anti-angiogenic therapy, or other immunotherapy agents in others.
| Sintilimab + chemotherapy (fluorouracil/cisplatin) | First-line standard for gastric/GEJ cancer; also used in NSCLC. Improves overall survival vs chemotherapy alone. |
| Sintilimab + bevacizumab biosimilar | First-line for hepatocellular carcinoma. Significantly extends PFS and OS vs single-agent bevacizumab. |
| Sintilimab + fruquintinib | Approved for advanced RCC and endometrial cancer (pMMR). Median PFS 22.2 months for RCC, substantially longer than standard therapy. |
| Sintilimab + ipilimumab N01 (IBI310) | Neoadjuvant regimen for MSI-H/dMMR resectable colon cancer. 82% pathological complete response rate; first CTLA-4 approval for colon cancer neoadjuvant setting. |
| Sintilimab monotherapy | Standard for relapsed/refractory Hodgkin lymphoma (second-line and beyond NSCLC, esophageal cancer in select settings. |
| Sintilimab switching strategies | If sintilimab fails, options include different chemotherapy partners, adding anti-angiogenic agents, or switching to alternative immunotherapy. Next step depends on cancer biology and prior response. |
If Sintilimab stops working
Some patients develop resistance or do not respond initially. Understanding resistance mechanisms guides next-line treatment decisions.
| Primary resistance (no initial response) | Occurs in 20-40% of patients. May be driven by low tumour immunogenicity, high regulatory T cell infiltration, or tumour microenvironment factors. Switching to chemotherapy-based combinations or alternative strategies warranted. |
| Acquired resistance (progression after initial response) | Can develop through PD-L1 downregulation, loss of neoantigen expression, or outgrowth of resistant clones. Repeat biopsy and next-generation sequencing identify new druggable mutations. |
| Pseudoprogression (imaging worsening, delayed response) | Rare with PD-1 inhibitors; new or enlarging lesions may represent immune infiltration before shrinkage. Confirmed with repeat imaging at 8-12 weeks and clinical assessment. |
| Next-generation sequencing and liquid biopsy | If progression confirmed, NGS identifies new mutations (EGFR, ALK, KRAS, TP53, others). Circulating tumour DNA (ctDNA) can assess disease burden and guide therapy switches. |
| Treatment switches for resistance | Options include chemotherapy + anti-angiogenic combinations, targeted therapy if new driver mutations identified, different immunotherapy regimens, or clinical trial enrollment. |
| Palliative and supportive care | If systemic therapy options exhausted, focus shifts to symptom control, quality of life, and clinical trial evaluation for experimental approaches. |
Cost of Sintilimab by country
Sintilimab pricing varies by country, healthcare system, and reimbursement status. In China, NRDL inclusion provides significant affordability through national insurance.
| China (NRDL covered) | Included in National Reimbursement Drug List for multiple indications. Patient out-of-pocket cost typically 20-40% per infusion after insurance coverage; exact amount depends on province and insurance tier. Cost per 200 mg infusion approximately RMB 2500-4000 with NRDL coverage. |
| USA | Not FDA-approved as of June 2026. Limited availability through clinical trials or expanded-access programs. Estimated cost if available via private sector: USD 8000-15000 per infusion, but varies widely. |
| Europe (UK, Germany, France) | Not approved by EMA. Access extremely limited; costs for imported drug range from EUR 8000-12000 per infusion if available privately. |
| India and other South Asian countries | No regulatory approval. Limited to clinical trials or compassionate-use programs. CancerFax can explore trial availability and international access pathways. |
| Middle East and Gulf states | Variable approval status. Some countries allow imported sintilimab; estimated cost USD 10000-18000 per infusion. Always confirm regulatory status and insurance coverage locally. |
| Patient assistance and affordability programs | Innovent Biologics may offer patient assistance in some regions. Check with treatment hospitals in China about cost-reduction programs or clinical trial access. |
Availability of Sintilimab globally
Sintilimab is primarily available in China through regulatory approval and NRDL reimbursement. Availability in other regions is limited as of June 2026.
China
Fully approved by NMPA for 10 indications. Included in National Reimbursement Drug List (NRDL). Available at major cancer centres, provincial hospitals, and private oncology clinics nationwide. NRDL coverage provides significant affordability.
USA
Not FDA-approved as of June 2026. Access limited to clinical trials, expanded-access programs, or import for personal use (restricted). Some research institutions may participate in international trials.
Europe (UK, Germany, France, etc.)
Not approved by EMA. No regulatory pathway to market approval established. Limited trial access. Private import possible but extremely expensive and not covered by national health insurance.
Japan and South Korea
Sintilimab regulatory status varies; some approvals in development. CancerFax can research current status in these markets. Clinical trial enrollment may be available.
India and South Asia
No regulatory approval by DCGI (India) as of June 2026. Clinical trial access possible at select centres. CancerFax can help identify trial opportunities or international treatment pathways.
Singapore, Australia, Canada
Regulatory approval status varies. Research local approval with your oncologist. Some patients access sintilimab through China-based treatment programs coordinated by CancerFax.
Sintilimab in current clinical trials
Sintilimab is actively studied in new combinations and cancer types worldwide. Many trials are open in China; some international sites participate in global programmes.
| New combination strategies | Ongoing trials combine sintilimab with targeted therapies, anti-angiogenic agents, and other immunotherapies (e.g. CTLA-4 inhibitors) for improved efficacy. |
| Neoadjuvant and adjuvant studies | Trials investigate sintilimab in early-stage disease (colon cancer, gastric cancer) both as neoadjuvant therapy before surgery and as adjuvant therapy after resection. |
| Biomarker and patient selection | Studies evaluate PD-L1 expression, tumour mutational burden, and microbiome factors to predict responders and optimize patient selection for sintilimab therapy. |
| Expansion into rare cancers | Phase 2 and 3 trials explore sintilimab in rarer malignancies (mesothelioma, biliary cancers, sarcomas) and hematologic diseases. |
| Immunotherapy durability | Long-term follow-up studies assess duration of response, relapse patterns, and quality of life in sintilimab responders beyond 2-3 years of follow-up. |
| Global and international trials | Some multinational trials enroll patients in Asia-Pacific regions and selected European/North American centres. CancerFax can identify trials matching your cancer type and location. |
Your treatment journey with Sintilimab
Diagnosis, staging, and molecular testing
First oncology consultation and treatment planning
Pre-treatment workup and consent
First sintilimab infusion
Early monitoring and toxicity management
Imaging response assessment
Ongoing treatment and long-term monitoring
Response, stable disease, or progression
Treatment completion or switch
Post-treatment follow-up and long-term surveillance
Questions to ask your oncologist about Sintilimab
- Is Sintilimab approved for my specific cancer type and stage in my country?
- Why is Sintilimab better than chemotherapy for me?
- How long will I take Sintilimab?
- What tests do I need before starting?
- What happens if Sintilimab does not work or stops working?
- What are the most serious side effects I should watch for?
- Can I have other treatments while on Sintilimab?
- What is the cost, and is it covered by my insurance?
- Is Sintilimab safe during pregnancy?
- How often will I have blood tests and scans?
How CancerFax supports Sintilimab patients
CancerFax helps patients navigate sintilimab access, treatment decisions, and international care coordination across China and beyond.
| Medical report review | Upload your pathology, imaging, and molecular testing results. CancerFax team reviews and explains implications for sintilimab eligibility and treatment planning. |
| Specialist connection | We connect patients with oncologists specialising in your cancer type at leading Chinese hospitals (Shanghai, Beijing, Guangzhou) that have extensive sintilimab experience. |
| Treatment access in China | We guide patients to NRDL-covered treatment at accredited hospitals, manage treatment coordination, and help navigate insurance reimbursement for NRDL indications. |
| Second opinion services | If unsure about sintilimab vs alternative therapies, or if treatment is not working, CancerFax arranges specialist second opinions from experienced oncologists. |
| Clinical trial matching | We identify ongoing sintilimab trials in China and select international sites. CancerFax helps assess eligibility and manage trial enrollment. |
| International patient coordination | For patients outside China, CancerFax explores access pathways: clinical trials, expanded-access programs, hospital partnerships, and treatment co-ordination if traveling to China. |
| Cost and affordability support | We help identify cost-reduction programs, patient assistance, and insurance pathways to make sintilimab affordable. |
| Side effect support | CancerFax nurses provide education on self-monitoring for immune-related side effects and guidance on when to seek emergency care. |
Frequently asked questions about Sintilimab
Common questions from patients and caregivers
Sintilimab (brand name Tyvyt) is an immunotherapy that blocks PD-1, a protein that cancer cells use to hide from the immune system. Unlike chemotherapy, which broadly kills fast-dividing cells, sintilimab helps restore the immune system's ability to recognize and attack cancer cells. This targeted approach means you typically avoid severe hair loss and nausea associated with traditional chemotherapy.
Response timelines vary by cancer type and patient factors. For Hodgkin lymphoma, many patients show improvement within 2-3 months. For solid tumours like lung cancer or hepatocellular carcinoma, imaging scans typically assess response every 6-8 weeks. Your oncologist will explain your personal milestones and monitoring schedule based on your specific diagnosis.
Sintilimab has relatively few drug interactions compared to some other immunotherapies. However, you must tell your oncologist and pharmacist about all medicines, supplements, and herbal products you take. Blood pressure medications, blood thinners, and certain immunosuppressants need careful review. Avoid live vaccines during treatment.
As of June 2026, Sintilimab is primarily approved and available in China under the National Medical Products Administration (NMPA). It is not yet approved by the FDA in the United States. If you live outside China, CancerFax can help explore whether access through clinical trials or international treatment programs is possible.
If imaging shows disease progression, your oncologist will first confirm that the progression is real (not pseudoprogression, which can rarely occur with immunotherapy). They may then recommend repeat biopsy or liquid biopsy for new biomarkers, NGS testing to identify new treatment targets, or switching to another therapy. Options depend on your cancer type, prior treatments, and overall health.
No. Sintilimab may harm the developing foetus and must not be used during pregnancy. Effective contraception is required throughout treatment. If you want to become pregnant, discuss this with your oncologist before starting sintilimab. Do not breastfeed while taking sintilimab or for a period after treatment ends, as determined by your doctor.
You will need blood tests before starting treatment and at regular intervals during therapy—typically every 3-4 weeks initially—to monitor blood counts, liver and kidney function, and inflammation markers. Imaging scans (CT, MRI, or PET-CT) are usually performed every 6-8 weeks to assess how the cancer is responding. Your team will explain the exact schedule for your situation.