NCT07257575

A Randomized Controlled Study of Serplulimab Combined With Chemotherapy for Locally Advanced Gastric Adenocarcinoma

A Phase II Randomized Controlled Clinical Study of Serplulimab Combined With Chemotherapy in the Treatment of Patients With Locally Advanced Gastric Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Gastric Cancer Stage III

Interventions

Type	Name	Description
DRUG	FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)+Serplulimab	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.
DRUG	FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)	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.

Timeline

• Start date: 2025-01-05
• Primary completion: 2027-01-31
• Completion: 2031-06-30
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China