A Study of Combination of Anti-PD1 Antibody-activated TILs and Chemotherapy in Colorectal Cancer
Colorectal Cancer Stage III
About this trial
This is an interventional treatment trial for Colorectal Cancer Stage III focused on measuring Colorectal Cancer, TIL, immunotherapy
Eligibility Criteria
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.
Sites / Locations
- Sun Yat-Sen University, Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
PD1-TIL combined with chemotherapy
Participants would received anti-PD-1 antibody-activated TILs after the final adjuvant chemotherapy.