NCT05588297

Preoperative Nivolumab Plus Bevacizumab Combined With Chemotherapy Before Surgery in Patients With pMMR/MSS Colorectal Cancer Liver Metastases

Safety and Efficacy of Nivolumab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Treatment of pMMR/MSS Colorectal Cancer Liver Metastases Patients：a Single-arm, Phase II, Prospective Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single-arm study aims to investigate the safety and efficacy of Nivolumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS Colorectal cancer liver metastases patients

Conditions

• Colorectal Cancer Liver Metastases

Interventions

Type	Name	Description
DRUG	CapOx(Capecitabine+ Oxaliplatin)	CapOx: Capecitabine is given orally at 1500mg / m² twice a day from day1-14 every 3 weeks for 4 cycles and Oxaliplatin is given by intravenous infusion at 200mg / m2 on Day 1 every 3 weeks for 4 cycles
DRUG	Bevacizumab	Bevacizumab is given intravenously at 10mg/kg on day 1 every 3 weeks for 4 cycles
DRUG	Nivolumab	Nivolumab is given intravenously at 360 mg on day 1 every 3 weeks for 4 cycles

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-03-01
• Completion: 2025-10-01
• First posted: 2022-10-20
• Last updated: 2022-10-20