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

NCT ID: NCT04525326

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 584 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard chemotherapy plus Cetuximab

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

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

mFOLFOX/FOLFIRI ( Standard Chemotherapy)

Intervention Type: DRUG

Standard Chemotherapy

standard chemotherapy plus Bevacizumab

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

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

mFOLFOX/FOLFIRI ( Standard Chemotherapy)

Intervention Type: DRUG

Standard Chemotherapy

Interventions

Cetuximab

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

Intervention Type: DRUG

Bevacizumab

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

Intervention Type: DRUG

mFOLFOX/FOLFIRI ( Standard Chemotherapy)

Standard Chemotherapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SHENKANG2020XU

Identifier Type: -

Identifier Source: org_study_id