DC-CIK Adoptive Cellular Therapy Combined With Post-Surgical Radiation Therapy for Resected Esophageal Cancer
NCT01691664 (internal ID: JR-02) was a prospective interventional study at Capital Medical University Cancer Center, Beijing Shijitan Hospital, evaluating whether autologous DC-CIK cell immunotherapy added to post-operative adjuvant radiation could improve disease-free survival in patients who had undergone curative-intent surgical resection of esophageal cancer. The study was led by Dr. Jun Ren MD PhD β Director of CMUCC, Beijing Key Laboratory for Therapeutic Cancer Vaccines, and a leading figure in DC-CIK immunotherapy research. The registry has not been updated since October 2019 and the study's estimated completion dates have both passed. This trial is not recruiting. This page is a scientific reference for patients and clinicians interested in this treatment approach.
About This Clinical Trial
Surgical resection with curative intent remains the cornerstone of treatment for locally advanced resectable esophageal cancer β but surgery alone carries a significant risk of disease recurrence. Even after complete (R0) resection, patients with tumour extension beyond the muscularis propria (T3-T4) or with nodal involvement (N+) face high rates of locoregional and distant recurrence. Postoperative (adjuvant) radiotherapy has been shown to reduce local-regional recurrence-free survival in this setting, and the role of adding immunotherapy to the adjuvant radiation backbone is a scientifically compelling question in this high-risk post-surgical population.
NCT01691664 (internal ID: JR-02) was the second in a pair of Capital Medical University esophageal cancer DC-CIK immunotherapy trials registered simultaneously in September 2012 β the companion study to NCT01691625 (JR-01), which tested DC-CIK added to definitive concurrent chemoradiation for inoperable locally advanced disease. JR-02 specifically enrolled patients who had already undergone curative surgical resection (esophagectomy) and were planned to receive adjuvant radiation. The study randomised patients to receive either adjuvant radiation alone or adjuvant radiation plus autologous DC-CIK cell immunotherapy, asking whether the cell therapy addition could extend disease-free survival over a 4-year follow-up period.
The study was conducted at Beijing Shijitan Hospital, Capital Medical University β the base of Dr. Jun Ren's DC-CIK research programme and the Beijing Key Laboratory for Therapeutic Cancer Vaccines. Dr. Ren and his team at Beijing Shijitan Hospital have enrolled more than 1,100 consecutive patients across multiple DC-CIK treatment trials between August 2012 and August 2022 β representing one of the largest institutional DC-CIK safety and efficacy datasets globally. The post-surgical, adjuvant setting studied in JR-02 represents a distinct clinical scenario from the concurrent chemoradiation setting of JR-01: the immunological environment post-surgery, the role of DC-CIK in residual micrometastatic disease control, and the interaction between adjuvant radiation and infused immune cells are all scientifically distinct questions.
As of May 2026, the ClinicalTrials.gov registry shows an UNKNOWN status for NCT01691664, with the last update submitted in October 2019. The study's estimated primary completion date of December 2021 and full completion date of June 2022 have both passed without a registry update. By contrast, its companion trial NCT01691625 (JR-01) was updated in February 2024 and marked as COMPLETED. It is highly probable that NCT01691664 also concluded β whether through completion of planned enrollment and follow-up, early termination, or modification β but the registry record does not confirm this. No results have been posted to ClinicalTrials.gov and no trial-specific publication has been identified.
NCT01691664 has not been updated in the ClinicalTrials.gov registry since October 2019. Its estimated completion dates (December 2021 and June 2022) have passed. This trial is almost certainly concluded but its final status is unconfirmed. It is not actively recruiting patients.
Trial at a Glance
Key registry details for NCT01691664. This is a study with unknown current status β its estimated completion dates have passed and it is not recruiting. Details are provided for scientific reference.
NCT01691664 has an UNKNOWN status and is not accepting patients. Contact CancerFax for currently active esophageal cancer options.
Treatment Being Studied
NCT01691664 addressed a specific and high-stakes clinical question: for patients who have undergone curative resection of locally advanced esophageal cancer and are receiving adjuvant radiation to reduce locoregional recurrence risk, can autologous DC-CIK cell immunotherapy added to that radiation further reduce the risk of disease recurrence and extend disease-free survival?
The post-surgical setting creates a distinct immunological context compared to concurrent chemoradiation in unresected disease. After complete surgical resection, there is no gross residual tumour, but micrometastatic disease may persist systemically. DC-CIK cells in the adjuvant setting would primarily serve as an immune surveillance mechanism β seeking out and eliminating residual circulating tumour cells or micrometastatic deposits that cannot be detected by imaging or pathology.
How the therapy works (in simple terms)
How it is given
Post-surgical adjuvant radiation therapy per institutional protocol, targeting the tumour bed and regional lymph nodes to reduce locoregional recurrence. This is the standard adjuvant approach for patients with T3-4 or N+ disease after R0 esophagectomy.
The same adjuvant radiation regimen plus a series of autologous DC-CIK cell infusions. Peripheral blood mononuclear cells are collected from the patient, matured ex vivo into a DC-CIK co-culture product, and reinfused β without requiring any additional lymphodepletion conditioning. The DC-CIK component adds a systemic anti-tumour immune mechanism complementary to the locoregional control provided by radiation.
Patients are followed for disease recurrence over a 4-year period (primary endpoint: disease-free survival). Quality of life is assessed at baseline and months 1, 3, 6, and 12. Immunological assessments including T cell subsets and cytokine secretion are performed at the same time points to evaluate whether DC-CIK infusions generate and sustain anti-tumour immune responses during the adjuvant period.
After complete surgical resection, macroscopic tumour is removed. But microscopic residual disease β circulating tumour cells, micrometastases in lymph nodes or distant organs β often persists. DC-CIK cells in the adjuvant setting are designed to mobilise systemic immune surveillance against these invisible residual cancer cells that radiotherapy cannot reach.
Who This Trial May Be For
The following eligibility criteria defined the patient population for NCT01691664. These are provided for scientific reference only β this study is not recruiting.
Patients required a confirmed diagnosis of esophageal carcinoma (squamous cell carcinoma or adenocarcinoma) established by cytology or histology prior to surgical resection.
Eligible patients had tumour extension beyond the muscularis propria (T3 or T4) and/or regional nodal involvement (N1-3), placing them at high risk for recurrence after surgery. Patients with confirmed distant metastatic disease (M1) were excluded.
The defining eligibility requirement was prior curative esophagectomy with en bloc resection, removing all known tumour with clear surgical margins (R0 resection). Patients with residual macroscopic tumour (R1 or R2 resection) were not the target population.
A minimum 3-week recovery interval from surgery to enrollment was required, ensuring patients had sufficiently recovered from esophagectomy before initiating adjuvant radiation and DC-CIK infusion.
No upper age limit. Karnofsky performance score of β₯ 70% was required. Patients needed adequate functional status to tolerate adjuvant radiotherapy and cell therapy infusions in the post-surgical setting.
Standard haematological and biochemical thresholds: haemoglobin β₯ 9 g/dL, neutrophils β₯ 1.5Γ10βΉ/L, platelets β₯ 100Γ10βΉ/L, creatinine β€ 1.5Γ ULN. Patients evaluated and cleared by a radiation oncologist prior to enrollment.
Eligibility Criteria
The following criteria are taken directly from the ClinicalTrials.gov registry for NCT01691664. These are provided for scientific and educational reference only. This study is not recruiting.
check_circleInclusion Criteria β May Be Eligible
- βCytologically or histologically confirmed esophageal carcinoma
- βTumour extension beyond muscularis propria (T3/T4) and/or nodal involvement (N+), without evidence of M1 distant metastatic disease
- βPrior en bloc resection with curative intent β all known tumour removed (R0)
- βNo residual metastatic disease post-resection
- βAge > 18 years
- βKarnofsky performance status β₯ 70%
- βAt least 3 weeks since prior surgery
- βNormal functions of heart, lung, liver, kidney, and bone marrow
- βHaemoglobin β₯ 9 g/dL
- βNeutrophil count β₯ 1.5Γ10βΉ/L
- βPlatelet count β₯ 100Γ10βΉ/L
- βSerum creatinine β€ 1.5Γ ULN
- βEvaluated and cleared by a radiation oncologist prior to enrollment
- βSigned informed consent
cancelExclusion Criteria β May Not Be Eligible
- ΓMetastatic disease (M1) at time of enrollment
- ΓPregnancy or nursing
- ΓPoor bone marrow, liver, or kidney function making radiation therapy intolerable
- ΓContraindication to irradiation: complete esophageal obstruction, deep esophageal ulcer, fistula to mediastinum, or haematemesis
NCT01691664 is not actively enrolling patients. If you have resected esophageal cancer and are exploring adjuvant immunotherapy options, contact CancerFax to identify currently active options.
Potential Benefits
These are the scientific reasons for combining DC-CIK cellular therapy with post-surgical adjuvant radiation in resected esophageal cancer. They reflect the study's design rationale and the broader published evidence β not specific results from NCT01691664.
Adjuvant radiation targets the tumour bed and regional nodes locoregionally. DC-CIK cells act systemically β circulating through the bloodstream to identify and destroy residual cancer cells that radiation cannot reach. Together, they address both the local recurrence risk and the systemic micrometastatic burden that drives distant recurrence.
Surgery induces transient immune suppression β due to the physiological stress response, anaesthesia effects, and post-operative inflammation. DC-CIK infusions in the recovery period may help restore anti-tumour immune surveillance precisely when natural immune function is compromised, potentially closing a window in which residual tumour cells could establish themselves.
CIK cells within the DC-CIK product kill tumour targets through NKG2D, DNAM-1, and Fas/FasL pathways that do not depend on MHC class I expression. Residual tumour cells that have downregulated HLA molecules β a frequent mechanism of immune escape in ESCC β remain susceptible to CIK-mediated killing.
Dendritic cells in the co-culture product present tumour-associated antigens to the immune system, potentially generating durable tumour-specific memory T cell responses. In the adjuvant setting, this immunological memory could provide sustained protection against late recurrence beyond the initial treatment period.
Autologous DC-CIK infusion does not require lymphodepletion conditioning. This is especially important in the post-surgical setting, where patients may have reduced marrow reserve and are already managing the physiological demands of esophagectomy recovery alongside radiation toxicity.
Adjuvant thoracic radiotherapy causes localised immune suppression, reducing T cell and NK cell populations in the irradiated field. Published data on DC-CIK combined with radiotherapy in esophageal cancer patients show that DC-CIK infusions can restore CD3+, CD4+, and NK cell populations and reduce bone marrow suppression β potentially offsetting radiation's immunosuppressive effects.
Esophagectomy achieves complete removal of the primary tumour, but cannot eliminate circulating tumour cells or micrometastatic deposits in distant organs or lymph nodes beyond the surgical field. DC-CIK cells provide a systemic, MHC-unrestricted immune surveillance mechanism that complements the locoregional control provided by adjuvant radiation.
Risks and Side Effects
The risk profile below reflects the known safety data for DC-CIK immunotherapy from the published literature, combined with the expected toxicities of adjuvant thoracic radiotherapy after esophagectomy. Specific adverse event data from NCT01691664 have not been published.
Adjuvant thoracic radiotherapy after esophagectomy carries risk of radiation oesophagitis (particularly relevant near the gastric conduit or anastomosis), radiation pneumonitis, pericarditis, cardiac toxicity, and haematological suppression. The risk profile is influenced by total radiation dose, field design, and the patient's post-surgical anatomy.
The 2023 retrospective safety review of 1,100 patients and 2,504 DC-CIK treatment cycles at Beijing Shijitan Hospital found adverse events to be predominantly mild: low-grade fever, transient fatigue, mild headache, and occasional joint pain. No fatal adverse events attributable to DC-CIK immunotherapy were identified across the entire dataset.
Patients in the adjuvant setting have recently undergone esophagectomy β a major thoracic surgical procedure with significant physiological demands. Post-surgical patients may have reduced bone marrow reserve, nutritional compromise, and altered respiratory function β all of which require careful clinical assessment before initiating adjuvant treatment.
DC-CIK infusion activates immune cytokine pathways (IL-2, TNF-Ξ±, IL-12) as part of its therapeutic mechanism. This cytokine activation is typically mild and self-limiting and does not produce the high-grade cytokine release syndrome seen with CAR-T therapy. Clinical monitoring during infusion is standard.
The specific adverse event profile from NCT01691664 has not been published or posted to the registry. The risk information above draws from the broader DC-CIK safety literature and specifically from Dr. Jun Ren's Beijing Shijitan Hospital dataset β which overlaps the same time period and institution as NCT01691664.
Post-surgical adjuvant radiation to the thorax carries risks of oesophagitis (in the anastomotic region), pneumonitis, radiation-related fatigue, and haematological suppression β all of which are relevant to the post-esophagectomy patient. DC-CIK adds a generally mild additional profile on top of this.
Trial Location and Hospital Information
NCT01691664 was conducted at Beijing Shijitan Hospital, Capital Medical University, Beijing Municipality (zip: 100038). This is the clinical home of Dr. Jun Ren's DC-CIK research programme β the Beijing Key Laboratory for Therapeutic Cancer Vaccines β and the site where more than 1,100 patients across multiple DC-CIK trials were enrolled between 2012 and 2022. The registry lists Dr. Jun Ren MD PhD as the direct contact for the trial at this location.
Beijing Shijitan Hospital, Capital Medical University Cancer Center, continues to operate as an active DC-CIK treatment programme. Dr. Jun Ren's group has dual academic ties to Duke University Medical Center (USA) and Massachusetts General Hospital (USA), and has enrolled patients from multiple countries across its DC-CIK research portfolio. International patients with resected esophageal cancer exploring adjuvant immunotherapy options should contact CancerFax to assess whether treatment access at CMUCC β within an active trial or through the clinical programme β is appropriate for their situation. β VERIFY: Confirm current clinical access pathway with the CMUCC team before communicating to patients.
How CancerFax Can Help
CancerFax is a global cancer navigation platform. For patients who have undergone surgical resection of esophageal cancer and are exploring adjuvant immunotherapy β including DC-CIK therapy, checkpoint inhibitors, or combinations β we provide structured, expert-led navigation.
Our medical team reviews your surgical pathology, operative reports, staging, prior treatment history, and current performance status to assess your eligibility for adjuvant immunotherapy options β including DC-CIK access at Capital Medical University Cancer Center and currently active adjuvant trials.
DC-CIK immunotherapy continues as a clinical programme at Beijing Shijitan Hospital (CMUCC). CancerFax can help coordinate access to Dr. Jun Ren's programme for patients seeking adjuvant DC-CIK therapy after esophagectomy β whether within an active trial or through the clinical treatment pathway.
We track currently recruiting adjuvant immunotherapy and chemoimmunotherapy trials for resected esophageal cancer β in China and internationally. If you were referred to this page looking for an active DC-CIK adjuvant trial, we can identify what is currently available and appropriate for your staging and surgical history.
Nivolumab adjuvant therapy is now approved for patients with residual disease after neoadjuvant CRT and esophagectomy. CancerFax can advise on checkpoint inhibitor options that may be accessible for your specific post-surgical situation β including approved regimens and access through active trials.
For international patients seeking treatment at Beijing Shijitan Hospital or other Beijing oncology centres, CancerFax provides practical support: medical visa guidance, accommodation near the hospital, interpreter coordination, and logistics for the adjuvant treatment period.
From record review to treatment coordination, CancerFax provides human-led, expert-supported navigation. We do not replace your surgeon or oncologist β we help you access specialist adjuvant options and global trial opportunities they may not have direct connections to.
CancerFax does not guarantee access to any specific treatment or clinical trial. Our role is to help patients access accurate information and appropriate pathways.
Frequently Asked Questions
Resected Esophageal Cancer β Looking for Adjuvant Immunotherapy Options?
This trial is not recruiting. But adjuvant DC-CIK immunotherapy at Capital Medical University Cancer Center, checkpoint inhibitor options after surgery, and other adjuvant approaches remain available. Submit your records for a no-obligation case review and CancerFax will identify what is currently appropriate for your situation.
The information on this page is for educational and patient-navigation purposes only. It does not replace medical advice, diagnosis, or treatment from a qualified physician. Clinical trial eligibility, enrollment, treatment decisions, and costs are determined only by the trial investigators, hospital, sponsor, and applicable regulations. CancerFax helps patients and families understand options and coordinate case review where appropriate, but does not guarantee trial acceptance, treatment response, or clinical outcome. All clinical decisions must be made in consultation with a qualified, licensed physician with access to the patient's complete medical information.
Related Pages on CancerFax
Β© CancerFax Β· Specialist cancer access and patient-navigation platform. CancerFax is not a medical institution, hospital, or clinical trial sponsor. Trial details may change; always confirm current eligibility, status, and costs directly with the trial center.