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UNKNOWNPHASE3

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

A Prospective Study on the Conversion Therapy of Ras / BRAF Wild Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases: Standard Chemotherapy Plus Cetuximab VS. Standard Chemotherapy Plus Bevacizumab

NCT04525326•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The primary tumor was confirmed by histology as colorectal adenocarcinoma
•2. primary right-sided colorectal adenocarcinoma
•3. Radiologic evidence suggests that the initial unresectable liver metastases
•4. RAS/BRAF gene wild-type states
•5. ECOG was 0 \~ 1
•6. Life expectancy ≥ 3 months
•7. Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
•8. 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);
•9. Sign the written informed consent to participate in the experiment

Exclusion Criteria

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

Key Dates

Start Date

October 1, 2020

Primary Completion Date

October 1, 2022

Completion Date

November 1, 2022

Last Updated

August 25, 2020

Enrollment

584

ESTIMATED participants

Conditions

Colorectal CancerLiver Metastases

Interventions

Cetuximab

DRUG

Bevacizumab

DRUG

mFOLFOX/FOLFIRI ( Standard Chemotherapy)

DRUG

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors