For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0), perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage, increase the R0 resection rate, and may improve the long-term survival. Combination of perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.
The incidence of gastric and gastroesophageal junction adenocarcinoma is increasing in China, and it is one of the most common malignant tumors in China. Surgery is the only possible way to cure gastric and gastroesophageal junction adenocarcinoma, however, over 70-80% of gastric/gastroesophageal junction adenocarcinoma patients in China are in advanced stage. Locally gastric/gastroesophageal junction adenocarcinoma (cT3-4bNanyM0) could be cured by multi-disciplinary therapies including surgery, immunotherapy and chemotherapy. Perioperative immunotherapy plus chemotherapy can downstage tumor T and N stage, increase the R0 resection rate, and may improve the long-term survival. However, the therapeutic effects still not satisfactory to date. Surufatinib, as the novel oral antivascular targeting drug, has been proved to be effective in neuroendocrine tumor. Combination of perioperative surufatinib and immunotherapy plus chemotherapy for locally advanced gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Surufatinib: 250mg qd，d1-21, q3w
Sintilimab：200mg ivdrip, d1, q3w
130mg/m2，iv drip for 2h，d1, q3w
S1：40\~60mg Bid，d1\~14, q3w
Fudan University Cancer Hospital
Shanghai, China
Pathological complete response（pCR）rate
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks
R0 resection rate
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Disease free survival (DFS)
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 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
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