Clinical trial NCT04525326: Conversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Liver Metastases
Keywords: Cetuximab
Bevacizumab
Liver Metastases
Colorectal Cancer
right-sided
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Conversion liver resection rate
timeFrame: up to 6 months
Secondary outcomes:
measure: objective response rate
timeFrame: up to 6 months
measure: Incidence of adverse events
timeFrame: up to 6 months
measure: Progression free survival
timeFrame: up to 3 years
measure: overall survival
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
References: