CLINICAL TRIALS IN CANCER:
COMPLETE PATIENT GUIDE

Clinical trials are scientifically controlled studies conducted in human subjects to assess new treatments, medications, procedures, and preventive approaches. They are the only pathway through which new cancer therapies move from laboratory to patient. Every drug, procedure, and intervention used in oncology today was validated through clinical trials.

“Clinical trials are not a 'last resort.' Many enroll patients at first or second line — offering cutting-edge options alongside or instead of standard chemotherapy.”

• Access Before Approval

  For patients with rare cancers, treatment-refractory disease, or mutation profiles with no approved therapy, a clinical trial may be the only access point for a potentially transformative treatment — often months or years before commercial availability.

• Standard of Care — Guaranteed

  All trial participants receive at minimum the current standard of care. No participant is given placebo-only treatment when an effective standard therapy exists. Regulatory frameworks in the US (FDA), EU (EMA), and China (NMPA) all require this.

• The Bench-to-Bedside Journey

  Before any therapy reaches a clinical trial, it undergoes 4–6 years of preclinical evaluation in cell lines and animal models. Only compounds demonstrating sufficient safety and biological activity receive regulatory clearance to enter first-in-human (Phase I) testing.

• Precision Trial Era

  Modern trials no longer enroll all patients with a cancer type — they enrol patients with specific mutations, fusions, or biomarker profiles. Comprehensive NGS testing is now essential to maximise trial eligibility options.

Trials are organised into four sequential phases, each with distinct objectives, patient numbers, and risk-benefit profiles. Understanding the phases is essential before deciding which trial is appropriate for your situation.

Clinical trials are not limited to drug testing. They span the full cancer care continuum — from prevention and early detection through to palliative care optimisation.

• Treatment Trials

  The most prevalent type — assessing new drugs, drug combinations, radiotherapy, surgery, immunotherapy, gene therapy, and cell therapy. Can test a new medicine, a new combination, a new sequence, or a new use of an existing approved treatment.

• Basket, Umbrella & Platform Trials

  The cutting edge of trial methodology. Basket trials: one treatment tested across multiple tumour types sharing a molecular target (e.g., NTRK fusions). Umbrella trials: multiple treatments in one tumour type stratified by molecular subtype. Platform trials: continuously enrolling adaptive designs that add or drop arms based on interim results.

• Prevention Trials

  Test drugs, vaccines, nutritional changes, or lifestyle modifications that may prevent cancer in healthy or high-risk individuals — e.g., chemoprevention in BRCA carriers, or HPV vaccine trials.

• Screening & Early Detection Trials

  Test innovative ways to diagnose cancers before symptoms appear — liquid biopsy panels, new imaging techniques, and AI-based diagnostic tools. Early detection remains one of the most powerful tools in reducing cancer mortality.

• Supportive Care & Quality-of-Life Trials

  Assess strategies for symptom control, adverse effect minimisation, and wellbeing during and after cancer therapy. Open to patients at any stage — including those already receiving standard treatment. Quality of life is a clinically validated endpoint that matters as much as tumour response.

• 4,000+Cancer Trials Registered in China (2023)Second only to the US — with 50,000+ trials on ChiCTR database and 1,000+ oncology trials actively enrolling simultaneously.
• 48–72 hrsCancerFax Trial Match TurnaroundFrom receiving medical records to delivering a prioritised list of matched open trials — including Chinese and international sites.
• 40–50%EGFR Mutation Rate in Chinese NSCLC Patientsvs 10–15% in Western populations — giving China's EGFR-targeted trial data unique statistical power and global relevance.
• $0Cost of Investigational Drug in Any Clinical TrialThe experimental treatment is always provided free by the trial sponsor — a legal and ethical requirement regardless of country or institution.

Every trial has defined inclusion and exclusion criteria that form the scientific basis for participant selection. Meeting criteria for one trial does not mean it is the right trial — criteria vary substantially between protocols.

These pivotal studies — including significant Chinese contributions — illustrate the scale of impact that well-designed clinical trials deliver.

Navigating the global clinical trial landscape is one of the most significant hurdles families face. This is the structured pathway — from confirming your diagnosis to first treatment on trial.

1. 1

   Confirm Your Diagnosis

   Ensure you have complete histopathology, molecular profiling (NGS), and staging reports. These form the eligibility assessment foundation — without them, trial teams cannot screen you.

2. 2

   Identify Your Biomarkers

   Many trials require specific mutation, fusion, amplification, or expression status. Comprehensive genomic profiling (CGP) covering 300–500 genes dramatically expands your trial option set compared to single-gene testing.

3. 3

   Search Trial Registries

   ClinicalTrials.gov (global) and ChiCTR (China) are the primary databases. Search by cancer type, intervention type, and geographic location. CancerFax maintains a curated, continuously updated database of active oncology trials across China's top 30 cancer centres.

4. 4

   Review Eligibility Criteria

   For each promising trial, carefully assess inclusion and exclusion criteria against your clinical profile. CancerFax screens your records against trial criteria and identifies top matches within 48–72 hours.

5. 5

   Contact the Trial Team

   Each trial lists a principal investigator and contact details. An inquiry does not commit you to enrolment. CancerFax coordinates directly with Chinese trial coordinators on your behalf — including language interpretation and eligibility pre-screening.

6. 6

   Eligibility Screening Visit

   If potentially eligible, the site schedules a screening visit — typically including repeat blood work, imaging, and biomarker confirmation. International patients can often complete partial screening before travelling to China.

7. 7

   Informed Consent

   If eligible, you receive a detailed informed consent document. Take time to read it, ask questions, and involve family. You can withdraw consent at any time without affecting access to other treatments at the facility.

8. 8

   Enrolment & Treatment Initiation

   If you consent and pass all screening criteria, you are enrolled and treatment begins per the trial protocol. The investigational drug is provided at zero cost by the trial sponsor from this point forward.

China has undergone unparalleled growth in oncology clinical trials over the last decade. From a marginal international player a decade ago, China is now one of the world's two dominant clinical trial ecosystems.

• Scale: 4,000+ Trials in 2023

  More than 4,000 cancer-related trials were registered in China during 2023, second only to the US. 50,000+ trials are now on the ChiCTR database; 1,000+ oncology trials are actively enrolling simultaneously at any time.

• Leading Institutions

  Fudan University Shanghai Cancer Center (FUSCC), Sun Yat-sen University Cancer Center (SYSUCC), Peking University Cancer Hospital, National Cancer Center Beijing, and Chinese PLA General Hospital collectively run the most active oncology trial programmes in Asia.

• EGFR Mutation & NSCLC Leadership

  China has the world's largest population of EGFR-mutated NSCLC patients (40–50% of Chinese NSCLC vs 10–15% in the West), giving its EGFR-targeted trial data unique statistical power. Furmonertinib, aumolertinib, and lazertinib trials offer osimertinib alternatives for C797S resistance.

• CAR-T & Haematology Leadership

  China has the most active CAR-T programmes globally — including novel dual-target constructs and allogeneic (off-the-shelf) approaches. Institutions including Institute of Hematology (Tianjin), Huashan Hospital, and Ruijin Hospital (Shanghai) run multiple concurrent haematology programmes.

• Domestically Developed Agents in Trials

  Sintilimab (Innovent), camrelizumab (HengRui), tislelizumab (BeiGene), furmonertinib, zanubrutinib, and hundreds more Chinese-origin agents are in active Phase II/III trials — often at biosimilar-price levels for enrolled participants.

• NMPA Regulatory Reform & ICH Membership

  Post-2017 NMPA reforms reduced oncology drug approval time from 5+ years to 12–18 months. China is now an ICH member — meaning Chinese trial data meets global GCP standards accepted by FDA and EMA. From 2020–2024, the NMPA approved more novel oncology drugs per year than any non-US regulatory authority.

The financial side of clinical trial participation is one of the most commonly misunderstood elements. Understanding what the sponsor covers — and what patients are responsible for — is essential before committing.

Accessing a clinical trial in China from South Asia, the Middle East, Africa, or Southeast Asia requires coordination across multiple domains. CancerFax manages this end-to-end.

1. 1

   Prepare Your Medical Records

   Chinese trial teams require: complete pathology + IHC report, full staging workup (CT chest/abdomen/pelvis, PET scan), treatment history with dates/regimens/best response/reason for discontinuation, recent blood tests, and cardiac evaluation if trial protocol requires it.

2. 2

   CancerFax Trial Matching

   Submit your medical records to CancerFax. Our medical team screens your clinical profile against active trials at China's top 30 cancer centres and delivers a prioritised match list within 48–72 hours — with eligibility rationale for each option.

3. 3

   Medical Visa for China

   Foreign trial participants enter China on a medical visa (S1 or S2). CancerFax coordinates the hospital invitation letter required for the visa application — without which the visa cannot be issued.

4. 4

   Travel & Accommodation

   All major Chinese cancer centres are in major cities with international facilities. CancerFax arranges: airport pickup and hospital transfer, bilingual patient coordinator for all clinical interactions, medical-stay hotel or serviced apartment near the hospital, and translation of all consent forms and clinical reports.

5. 5

   On-Trial Support

   CancerFax provides daily clinical communications, family updates, and liaison with the treating team throughout the treatment period. FUSCC and SYSUCC operate dedicated international patient centres with English-speaking oncologists and case managers.

6. 6

   Post-Trial Follow-Up

   Most trials require long-term follow-up per protocol. For international participants, CancerFax facilitates remote monitoring coordination between the Chinese trial site and the patient's home oncologist — ensuring continuity of care after return.

Clinical trials operate under a robust ethical and regulatory framework. Understanding your rights as a trial participant is as important as understanding the science.

• Informed Consent

  Before enrolment you receive a detailed informed consent document covering: trial objectives, experimental treatment description, known risks and benefits, alternatives, and your rights. You can withdraw at any time without penalty to your other care. Your withdrawal cannot be refused.

• Ethics Committees & Institutional Review

  All trials must receive ethics committee (IRB/EC) approval before enrolling a single patient. In China, NMPA-regulated IRBs at every participating institution independently review and approve protocols. No trial can begin without this multi-level ethical oversight.

• Data Safety Monitoring Board (DSMB)

  Most Phase II and all Phase III trials operate with an independent DSMB — clinicians, statisticians, and ethicists who review unblinded interim safety and efficacy data at predefined intervals. The DSMB can pause or stop a trial at any time if safety signals emerge.

• Adverse Event Reporting

  All adverse events must be reported and graded (Grade 1–5 per CTCAE criteria). Serious adverse events — requiring hospitalisation, life-threatening, or fatal — must be reported to regulators within 24 hours. The trial site manages all treatment-related serious adverse event care at zero cost to you.

In-depth guides on specific cancer types, treatments, and logistics for international patients.

Frequently Asked Patient Questions

The most common questions from patients and families considering clinical trial participation.