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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04525326
• Other study ID #: SHENKANG2020XU
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: August 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 584
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ß - 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion liver resection rate	Rate of conversion from initially unresectable liver metastases to resectable ones	up to 6 months
Secondary	objective response rate	rate of objective response for therapy(according to RECIST 1.0)	up to 6 months
Secondary	Incidence of adverse events	Incidence of adverse events	up to 6 months
Secondary	Progression free survival	Progression free survival	up to 3 years
Secondary	overall survival	overall survival	up to 5 years