Neoadjuvant chemotherapy has been recommended by a series of treatment guidelines for the neoadjuvant treatment of locally advanced G/GEJ cancer. Although with clinical efficacy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with sintilimab and bevacizumab biosimilar (IBI305) in the neoadjuvant treatment for locally advanced G/GEJ cancer.
This is a prospective, multicenter, single-arm, phase II trial. A total of 58 patients will be enrolled. Eligible patients will be registered and receive three cycles of CAPOX plus sintilimab and bevacizumab biosimilar (IBI305) regimen. Radical D2 gastric cancer resection will be performed 6-8 weeks after the last administration of chemotherapy plus plus sintilimab and bevacizumab biosimilar (IBI305). The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS) and safety profile of the neoadjuvant regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Laparoscopic exploration should be performed to detect occult peritoneal metastases and inspect the primary lesion, liver, diaphragm, pelvic organs, bowel and omentum. 3 cycles of neoadjuvant therapy will be administered: capecitabine: 100 mg/m2, Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; sintilimab: 200 mg, iv drip, d1, bevacizumab biosimilar (IBI305) 10mg /Kg, iv drip, d1, q3w. Radical D2 gastric cancer resection will be performed within 6-8 weeks after the last administration of chemotherapy plus sintilimab and bevacizumab biosimilar (IBI305). The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with CAPOX regimen for up to 3 cycles.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
pCR rate
defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy
Time frame: 6 months after the last subject participating in
R0 resection rate
defined as the rate of the complete surgical removal of any residual cancer cells in the tumor bed
Time frame: 6 months after the last subject participating in
MPR rate
defined as tumor residual cells ≤10% in the surgical specimen
Time frame: 6 months after the last subject participating in
Event-free survival
defined as the time from randomization to occurrence of a major adverse clinical event, such as failure to achieve remission, relapse, and death during remission.
Time frame: 2 years after the last subject participating in
Overall survival
defined as the time from randomization to occurrence of death during remission.
Time frame: 2 years after the last subject participating in
Treatment-related adverse events
Treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 3 months after the last administration of drugs
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