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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participants would received one dose anti-PD-1 antibody-activated TILs at the final cycle of XELOX regimen chemotherapy
Sun Yat-Sen University, Cancer Center
Guangzhou, Guangdong, China
RECRUITINGDisease-free survival (DFS)
DFS is defined as the time from surgery until tumor recurrence or death.
Time frame: 6 months
Overall survival (OS)
OS is defined as the time from surgery until death from any cause
Time frame: 6 months
Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)
Time frame: 3 weeks
Immune cell subgroup and cytokine level
The number and secreted cytokines of cluster of differentiation 3 (CD3+), CD8+, CD4+ or CD56+ T cells
Time frame: 1 months
The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions )
Participants were interviewed with the EQ-5D-5L (EuroQol Group, Chinese versions). There are numbers from 0 to 100 on this scale of the EQ-5D-5L. 100 represents the best health condition you can imagine, and 0 represents the worst health condition in your imagination. Please put an X on the scale to indicate how healthy you are today. And the number you marked on the scale represents your health condition today.
Time frame: 3 weeks
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