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

Sponsor
Shanghai Changzheng Hospital
Study ID
NCT05588297
Phase
PHASE2
Status
Unknown

Conditions

  • Colorectal Cancer Liver Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CapOx(Capecitabine+ Oxaliplatin) — DRUG
    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
  • Bevacizumab — DRUG
    Bevacizumab is given intravenously at 10mg/kg on day 1 every 3 weeks for 4 cycles
  • Nivolumab — DRUG
    Nivolumab is given intravenously at 360 mg on day 1 every 3 weeks for 4 cycles

Study Details

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

Key Dates

Start date
Oct 31, 2022
Status verified
Oct 2022
Primary completion
Mar 31, 2023
Completion
Oct 31, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Bevacizumab + CAPOX as neoadjuvant treatment for 4 cycles
    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; Bevacizumab：Bevacizumab is given intravenously at 10mg/kg on day 1 every 3 weeks for 4 cycles; Nivolumab：Nivolumab is given intravenously at 360 mg on day 1 every 3 weeks for 4 cycles;

Primary Outcome Measure

R0 recession rate [ Time Frame: 10 weeks ]

Central Contacts