Colorectal Cancer Stage III Clinical Trial
Official title:
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.
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.
Postoperative colon cancer participants received 4 to 8 cycles of XELOX regimen adjuvant
chemotherapy and received anti-PD1 antibody-activated TILs on the day 15 of the final cycle
of chemotherapy.
Fresh tumor tissues or sentinel lymph nodes were collected from participants with
postoperative colon cancer, and the tumor tissues were digested with type IV collagenase at
37 °C for 2 to 4 hours. The cell pellet was washed, suspended in medium containing 10% AB
serum, planted in a 24-well cell culture plate, and periodically changed according to the
growth of the cells. After culturing for 2 to 3 weeks, TILs were co-stimulated with
radioactively irradiated allogeneic peripheral blood mononuclear cells (PBMCs) and were
expanded in 100 ml of Interleukin-2 (IL-2) medium in a cell culture flask. After rapid
expansion for 15 days, the number of cells reached 0.1-1*10^10 cells. Before cell transfer,
TILs were incubated with anti-PD-1 antibody, and a fraction of the TILs were collected to
assess their number, phenotype, and viability of cells, and to test for possible
contamination by bacteria, fungi, or endotoxins. Then, autologous TILs (0.1-1*10^10 cells)
were transferred to participants via intravenous infusion.
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