NCT05742425

Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases

The Efficacy and Safety of Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of pMMR/Ras/BRAF Wild-type Unresectable Colon Cancer Peritoneal Metastases: a Multicenter Single-arm Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Multicentric randomised trial. The goal of this clinical research study is to evaluate the efficacy and safety of serplulimab combined with FOLFIRI+bevacizumab in the treatment of pMMR/Ras/BRAF wild-type unresectable peritoneal metastasis of colon cancer.

Conditions

• Unresectable Colon Cancer Peritoneal Metastases
• PMMR/Ras/BRAF Wild-type

Interventions

Type	Name	Description
DRUG	Serplulimab Combined With FOLFIRI and Bevacizumab	For patients with confirmed failure to reach CC0/1, they should be treated with sullizumab combined with FOLFIRI+bevacizumab for 4-8 cycles within 3 weeks after the exploration operation. After the end of the 4th and 8th cycles, they should be evaluated with imaging and MDT. If the conversion is successful, they should be treated with a second exploration operation within 3-4 weeks, The patients with CC0/1 can be evaluated for tumor reduction surgery (CRS) combined with intraperitoneal hyperthermic perfusion chemotherapy (HIPEC), and the follow-up treatment plan will be selected according to the clinical situation of the patients after surgery; If CC0/1 cannot be evaluated after the second exploration surgery and CC0/1 cannot be performed after the imaging evaluation, other chemotherapy and optimal supportive treatment will be performed according to the situation.

Timeline

• Start date: 2023-03-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2023-02-24
• Last updated: 2023-02-24

Locations

1 site across 1 country: China