A Study of Combination of Anti-PD1 Antibody-activated TILs and Chemotherapy in Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03904537|
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Stage III||Biological: anti-PD-1 antibody-activated TILs||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: PD1-TIL combined with chemotherapy
Participants would received anti-PD-1 antibody-activated TILs after the final adjuvant chemotherapy.
Biological: anti-PD-1 antibody-activated TILs
Participants would received one dose anti-PD-1 antibody-activated TILs at the final cycle of XELOX regimen chemotherapy
- Disease-free survival (DFS） [ Time Frame: 6 months ]DFS is defined as the time from surgery until tumor recurrence or death.
- Overall survival (OS) [ Time Frame: 6 months ]OS is defined as the time from surgery until death from any cause
- Severity of adverse events [ Time Frame: 3 weeks ]According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
- Immune cell subgroup and cytokine level [ Time Frame: 1 months ]The number and secreted cytokines of cluster of differentiation 3 (CD3+), CD8+, CD4+ or CD56+ T cells
- The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions ) [ Time Frame: 3 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904537
|Sun Yat-Sen University, Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Jian-Chuan Xia, Ph.D. 86-20-87345699 firstname.lastname@example.org|
|Contact: De-Sheng Weng, Ph.D. 86-20-87343404 email@example.com|
|Principal Investigator: De-Sheng Weng, Ph.D.|
|Sub-Investigator: Jian-Chuan Xia, Ph.D.|