Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA. This study aims to assess the safety and efficacy of JS001 in combination with FOLFOX as adjuvant/neoadjuvant treatment for patients with locally advanced colon cancer.
Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer and it can improve the R0 resection rate, as well as reduce recurrence rate, but the overall responding rate is limited. Currently, immune checkpoint blocked (ICB) emerges as a promising approach in early colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA in melanoma. This study was designed as a prospective, randomized, controlled trial. Patients who meet the enrollment criteria will receive FOLFOX (Q2W) and JS001 (3mg/kg, Q2W) or only FOLFOX for neoadjuvant treatment 6 cycles in pre-operation and same treatment after operation, a total of six months. The assessment will be conducted in the 6th week and 13th week from the initiation date in the first cycle. The patients will be followed up for 5 years. The pCR rate, rCR rate, ORR, DFS, OS and Safety will be compared. This study aims to assess the safety and efficacy of JS001 in combination with FOLFOX as adjuvant/ neoadjuvant treatment for patients with locally advanced colon cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Anti-PD-1 monoclonal antibody combined with chemotherapy in patients with locally advanced colon cancer (perioperative treatment)
Folfox
Shan Zeng
Changsha, Hunan, China
RECRUITINGpCR rate
Pathologic complete response rate
Time frame: From the initiation date of first cycle to the date of operation, up to 5 months (each cycle is 2 weeks)
rCR rate
Radiographic complete response rate
Time frame: From the initiation date of first cycle to the date of operation, up to 5 months (each cycle is 2 weeks)
ORR
Immunotherapy overall response rate
Time frame: From the initiation date of first cycle to the date of operation, up to 5 months (each cycle is 2 weeks)
DFS
Disease-free survival
Time frame: From the initiation date of first cycle to the date of first documented progression, loss to follow up or death from any causes, whichever came first, up to 5 years (each cycle is 2 weeks)
OS
Overall survival
Time frame: From the initiation date of first cycle to the date of death from any causes or loss to follow up, whichever came first, up to 5 years (each cycle is 2 weeks)
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