Conversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases

Sponsor
Fudan University
Study ID
NCT04525326
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab — DRUG
    mFOLFOX+Cetuximab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis
  • Bevacizumab — DRUG
    mFOLFOX+Bevacizumab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis
  • mFOLFOX/FOLFIRI ( Standard Chemotherapy) — DRUG
    Standard Chemotherapy

Study Details

The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. The United States NCCN guidelines do not recommend standard chemotherapy combined with anti EGFR monoclonal antibody for patients with right colon cancer. The European ESMO guidelines recommend that patients with Ras / BRAF wild-type right-sided colon cancer should first consider three drugs ± bevacizumab, but considering the objective response rate results, standard chemotherapy + anti EGFR monoclonal antibody is still one of the choices. China CSCO guidelines recommend standard chemotherapy ± bevacizumab, and also recommend standard chemotherapy + cetuximab for patients with right-sided colon cancer. Therefore, the targeted therapy for RAS / BRAF wild-type metastatic right colon cancer is still controversial. Therefore, we are ready to carry out the clinical trial of cetuximab and bevacizumab in conversion therapy for RAS / BRAF wild-type metastatic right colon cancer. The conversion resection rate is the primary point, and the objective response rate, perioperative safety and long-term survival are the secondary points.

Key Dates

First listed
Aug 25, 2020
Start date
Oct 1, 2020
Status verified
Aug 2020
Primary completion
Oct 1, 2022
Completion
Nov 1, 2022

Study Design

Enrollment
584 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: standard chemotherapy plus Cetuximab
  • Experimental: standard chemotherapy plus Bevacizumab

Primary Outcome Measure

Conversion liver resection rate [ Time Frame: up to 6 months ]

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