This study was a phase I/II trial initiated by the investigator to evaluate the safety and tolerability of anti-PD-1 antibody-activated TILs combined with adjuvant chemotherapy in participants with stage II-IIIA non-small cell lung cancer. 20 participants were enrolled and anti-PD-1 antibody-activated TILs was infused into participants after the final cycle chemotherapy to assess the safety and disease-free survival.
Postoperative non-small cell lung cancer received 4 cycles of docetaxel and cisplatin 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 non-small cell lung 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 receive one dose of anti-PD1 antibody-activated TILs at the final cycle of docetaxel and cisplatin (DP) regimen chemotherapy.
Sun Yat-Sen University, Cancer Center
Guangzhou, Guangdong, China
RECRUITINGSeverity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: 3 weeks
Disease-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: 12 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.