For locally advanced esophagogastric junction and gastric cancer (cT3-4aNxM0 or cT2N+M0), neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early before local therapy has begun, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate. JS001 in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate safety and efficacy of JS001 in combination with perioperative chemotherapy in locally advanced esophagogastric junction and gastric cancer. Differences in gut microbiome and tumor immune microenvironment were detected to screen people who were more sensitive to immunotherapy.
Gastric cancer (GC) is one of the leading causes of cancer-related deaths worldwide and a substantial global health burden. Surgery is the only possible way to cure gastric cancer, however, more than 80% of the Chinese patients are diagnosed at advanced stages. Locally advanced esophagogastric junction and gastric cancer (cT3-4aNxM0 or cT2N+M0) could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. Neoadjuvant chemotherapy can downstage T and N stage, treated distant micrometastases early before local therapy has begun, and finally improve the long-term survival. However, the therapeutic effects remain unsatisfactory. PD-1 antibody has demonstrated its efficacy in metastatic gastric cancer and has been proved to be effective in neoadjuvant setting in lung cancer and melanoma. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate. JS001 in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate safety and efficacy of JS001 in combination with perioperative chemotherapy in locally advanced esophagogastric junction and gastric cancer. Differences in gut microbiome and tumor immune microenvironment were detected to screen people who were more sensitive to immunotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
XELOX: Oxaliplatin+Capecitabine; SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40\~60mg Bid, d1\~14, q3w; Capecitabine: 1000mg/m2 Bid, d1-14, q3w; Neoadjuvant chemotherapy for 4 cycles, adjuvant chemotherapy for 4 cycles. Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w Drug: S1 S-1: 40\~60mg Bid，d1\~14, q3w Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA JS001: 240mg, ivdrip, d1, q3w; S-1:40\~60mg Bid, d1\~14, q3w; Capecitabine: 1000mg/m2 Bid, d1-14, q3w; Neoadjuvant chemotherapy for 4 cycles, adjuvant chemotherapy for 4 cycles. Drug: JS001 JS001, recombinant humanized anti-PD-1 monoclonal antibody for injection; 240mg ivdrip, d1, q3w. Other Name: PD-1 antibody Drug: Oxaliplatin Oxaliplatin: 130mg/m2,iv drip for 2h, d1, q3w Drug: S1 S-1: 40\~60mg Bid,d1\~14, q3w Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA
XELOX: Oxaliplatin+Capecitabine; SOX: Oxaliplatin+S-1 JS001: 240mg, ivdrip, d1, q3w; S-1:40\~60mg Bid, d1\~14, q3w; Capecitabine: 1000mg/m2 Bid, d1-14, q3w; Neoadjuvant chemotherapy for 4 cycles, adjuvant chemotherapy for 4 cycles. Drug: JS001 JS001, recombinant humanized anti-PD-1 monoclonal antibody for injection; 240mg ivdrip, d1, q3w. Other Name: PD-1 antibody Drug: Oxaliplatin Oxaliplatin: 130mg/m2,iv drip for 2h, d1, q3w Drug: S1 S-1: 40\~60mg Bid,d1\~14, q3w Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA
Fujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGThe six affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGGuangdong Provincial Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine,
Guangzhou, Guangdong, China
RECRUITINGMao ming people's hospital
Maoming, Guangdong, China
NOT_YET_RECRUITINGPeking University Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGThe Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGZhongshan People's Hospital
Zhongshan, Guangdong, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGMajor pathologic response (MPR)
It is defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 14 weeks
Disease-free survival (DFS)
The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented recurrence.
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Overall survival(OS)
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months
pCR
Pathological complete response after neoadjuvant immunotherapy and(or) chemotherapy
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 14 weeks
R0 resection rate
Rate of microscopically margin-negative resection
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 14 weeks
Adverse event incidence rate
Number of participants with treatment-related adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v4.03
Time frame: Patients will be assessed for adverse events throughout the study at every visit during treatment and at 3-month follow-up visit (3 months after treatment ends)
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