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

NCT04525326 | Unknown Phase 3

• 1 other identifier: SHENKANG2020XU
• Study Type: interventional
• Target: 584
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Cancer; Liver Metastases

Keywords

Cetuximab; Bevacizumab; Liver Metastases; Colorectal Cancer; right-sided

Outcome Measures

Primary Outcomes (1)

• Conversion liver resection rate

  Rate of conversion from initially unresectable liver metastases to resectable ones

  up to 6 months

Secondary Outcomes (4)

• objective response rate

  up to 6 months

• Incidence of adverse events

  up to 6 months

• Progression free survival

  up to 3 years

• overall survival

  up to 5 years

Study Arms (2)

standard chemotherapy plus Cetuximab

EXPERIMENTAL

Drug: Cetuximab; Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy)

standard chemotherapy plus Bevacizumab

EXPERIMENTAL

Drug: Bevacizumab; Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy)

Interventions

Cetuximab DRUG

mFOLFOX+Cetuximab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis

standard chemotherapy plus Cetuximab

Bevacizumab DRUG

mFOLFOX+Bevacizumab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis

standard chemotherapy plus Bevacizumab

mFOLFOX/FOLFIRI ( Standard Chemotherapy) DRUG

Standard Chemotherapy

standard chemotherapy plus Bevacizumab; standard chemotherapy plus Cetuximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The primary tumor was confirmed by histology as colorectal adenocarcinoma
• primary right-sided colorectal adenocarcinoma
• Radiologic evidence suggests that the initial unresectable liver metastases
• RAS/BRAF gene wild-type states
• ECOG was 0 \~ 1
• Life expectancy ≥ 3 months
• Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
• Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization);
• Sign the written informed consent to participate in the experiment

You may not qualify if:

• Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
• Known or suspected extrahepatic metastasis
• Patients with known hypersensitivity to any component of the study treatment
• Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
• Acute or subacute intestinal obstruction
• Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
• She had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
• Known drug / alcohol abuse
• No legal capacity or limited legal capacity
• There is peripheral neuropathy

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share