A Phase 2 interventional study of FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)+Serplulimab and FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel) in Gastric Cancer Stage III, sponsored by Guangdong Provincial People's Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Guangdong Provincial People's Hospital · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to learn if FLOT chemotherapy combined with serplulimab can improve the pathological complete response (pCR) rate in patients with stage III gastric cancer. The main question it aims to answer is:
Can FLOT chemotherapy combined with serplulimab improve the pathological complete response (pCR) rate in patients with stage III gastric cancer? Researchers will compare serplulimab with a blank control group to see if it can improve the pathological complete response (pCR) rate in patients with stage III gastric cancer.
Participants will :
Receive serplulimab combined with FLOT chemotherapy or FLOT chemotherapy alone every 2 weeks Undergo imaging assessments at 4 weeks and 8 weeks Undergo surgery based on imaging results after 8 weeks Receive postoperative serplulimab combined with adjuvant chemotherapy or adjuvant chemotherapy alone
Gastric cancer (GC) remains a major global health challenge, with approximately 1 million new cases and 650,000 deaths reported annually in recent years. The incidence rate of GC is significantly higher in Asia, particularly in South Korea and China. Specifically, according to the 2020 statistics from the International Agency for Research on Cancer (IARC), China accounts for 44% of global incident cases and 48.6% of global mortality cases related to gastric cancer, respectively. Furthermore, in 2022, China recorded 358,700 new gastric cancer cases and 260,400 deaths annually. The overall survival rate and median survival time of Chinese GC patients were 33.53% and 28.68 months, respectively.
In recent years, perioperative treatment has remained a research hotspot in the field of gastric cancer. Prior to the advent of the immunotherapy era, a two-drug combination regimen (SOX regimen: oxaliplatin plus S-1) served as the primary standard of care across East Asia. Notably, findings from the RESOLVE study have established the SOX regimen as one of the standard treatment options for the perioperative management of gastric cancer in China. In contrast, based on the outcomes of the FLOT4-AIO study, the FLOT regimen has long been the cornerstone of perioperative chemotherapy for gastric cancer in Western countries. More recently, the MATTERHORN study integrated immunotherapy into the perioperative treatment landscape, with results demonstrating that the addition of immunotherapy to the FLOT regimen further significantly improves event-free survival (EFS) and overall survival (OS). The success of this pivotal study has revolutionized our understanding of perioperative immunotherapy, and the FLOT-immunotherapy combination has now gained widespread acceptance in clinical practice.
Serplulimab is a monoclonal antibody with demonstrated safety and favorable clinical efficacy across multiple cancer types. Therefore, the objective of this clinical trial is to evaluate whether FLOT chemotherapy combined with serplulimab can enhance the pathological complete response (pCR) rate in patients with stage III gastric cancer.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 138 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
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Laboratory test results within 7 days prior to enrollment must meet the following criteria:
Exclusion Criteria:
Drug: FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)+Serplulimab
Drug: FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)
The subjects will first receive four cycles of neoadjuvant FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel) combined with serplulimab treatment, administered once every two weeks (Q2W). Imaging assessments will be conducted after the completion of the 2nd and 4th cycles of neoadjuvant therapy, followed by standard surgery. Postoperatively, they will continue with four cycles of adjuvant chemotherapy based on fluoropyrimidine combined with serplulimab, starting 4-6 weeks after surgery.
The subjects will first receive four cycles of neoadjuvant FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel) treatment, administered once every two weeks (Q2W). Imaging assessments will be conducted after the completion of the 2nd and 4th cycles of neoadjuvant therapy, followed by standard surgery. Postoperatively, they will continue with four cycles of adjuvant chemotherapy based on fluoropyrimidine, starting 4-6 weeks after surgery.
pCR rate
pathological complete regression rate
Time frame: Perioperative
MPR rate
Time frame: Perioperative
R0 resection rate
Time frame: Perioperative
OS
Time frame: 5 years
EFS
Time frame: 5 years
perioperative complication rate
Time frame: Up to postoperative 30 days
Chemotherapy-related side effects
Time frame: At the end of each cycle of chemotherapy (each cycle is 14 days)
Plan to share: No
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This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial People's Hospital