Clinical trial · Interventional
A Study of Combination of Anti-PD1 Antibody-activated TILs and Chemotherapy in Colorectal Cancer
A Phase I/II Study of Combination of Anti-Programmed Cell Death Protein 1(Anti-PD1) Antibody-activated Autologous Tumor Infiltrating Lymphocytes (TILs) and Chemotherapy in the Treatment of Stage III Colorectal Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was a phase I/II trial initiated by the investigator to evaluate the safety and tolerability of anti-programmed cell death protein 1 (anti-PD1) antibody-activated autologous tumor-infiltrating lymphocytes (TILs) combined with adjuvant chemotherapy in participants with stage III colon cancer. Twenty participants were enrolled and anti-PD1 antibody-activated TILs was infused into participants after the final of adjuvant chemotherapy to assess the safety and 3-year disease-free survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Stage III | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-PD-1 antibody-activated TILs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD1-TIL combined with chemotherapy
- description
- Participants would received anti-PD-1 antibody-activated TILs after the final adjuvant chemotherapy.
- interventionNames
- Biological: anti-PD-1 antibody-activated TILs
Primary outcomes (1)
- measure
- Disease-free survival (DFS）
- timeFrame
- 6 months
- description
- DFS is defined as the time from surgery until tumor recurrence or death.
Secondary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with stage III colorectal cancer and scheduled to receive adjuvant chemotherapy postoperation. * Age 18 to 75 years. * Willing to sign a durable power of attorney. * Able to understand and sign the Informed Consent Document. * Life expectancy of greater than six months. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen. * Adequate organ function. * Serology: Seronegative for HIV antibody. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus. •Hematology: white blood cell count (\> 3500/mm(3)). Platelet count greater than 100,000/mm(3). Hemoglobin greater than 9.0 g/dl. •Chemistry: Serum Alanine aminotransferase/Aspartate aminotransferase less or equal to 2.5 times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl. Exclusion Criteria: * Previous treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) , anti-PD-1, and anti-Programmed death-ligand 1(PD-L1). * Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. * Allogeneic tissue/organ transplantation. * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). * History of autoimmune disease * Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). * Concurrent antineoplastic therapies and systemic steroid therapy.
References
Publications (0)
Data not yet available