First-line Treatment of MCapOX + Cetuximab Vs. MFOLFOX6 + Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided MCRC: a Multicenter, Randomized, Controlled, Phase III Study

Launched by MENG QIU · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment combinations for patients with a specific type of advanced colorectal cancer that cannot be surgically removed. The treatments being compared are mCapOX (which includes capecitabine and oxaliplatin) plus cetuximab versus mFOLFOX6 (which includes fluorouracil, leucovorin, and oxaliplatin) plus cetuximab. Both combinations include cetuximab, a drug that helps the immune system fight cancer, but this study aims to find out which combination works better for patients with wild-type RAS and BRAF genes, who have left-sided metastatic colorectal cancer.

To be eligible for this trial, participants must be adults aged 18 or older with a confirmed diagnosis of this type of colorectal cancer and have at least one measurable tumor. They should not have had any prior chemotherapy for this cancer and must meet specific health criteria, such as certain blood test results. Patients will be monitored throughout the study to see how well the treatments work and to check for any side effects. This trial is not yet recruiting participants, but it aims to improve treatment options for patients facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able to provide written informed consent and can understand and comply with the requirements of the study.
• • Men and women ≥ 18 years of age.
• • Patients with histologically or cytologically confirmed RAS and BRAF wild-type, MSS/pMMR, metastatic left-sided colorectal adenocarcinoma.
• • Presence of at least one evaluable lesion, as defined in RECIST Version 1.1.
• • With an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• • No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy.
• • According to the imaging findings and surgical assessment of initial unresectable, synchronous metastatic colorectal cancer, no serious complications of the primary tumor (obstruction, perforation, massive hemorrhage that cannot be treated in internal medicine, etc.) .
• • Requirements for lab indicators: neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 75 × 10\^9/L, hemoglobin ≥ 8 g/dL; total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH \< 1500 U/L; creatinine clearance (calculated according to Cockcroft and Gault formula) \> 50 mL/min or serum creatinine ≤ 1.5 × UNL.
• Exclusion Criteria:
• • Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.
• • Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
• • Hypersensitivity to any therapeutic agent.
• • Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study.
• • Patients who have failed one or more palliative chemotherapy regimens.
• • Patients with uncontrolled hepatitis B virus.
• • Peripheral neuropathy ≥ CTC grade 2.
• • Neurological or psychiatric disorders affecting cognitive performance.
• • Patients with central nervous system metastasis could not be controlled with radiotherapy.
• • Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation.
• • Uncontrolled concomitant diseases within 6 months before the study, including unstable angina, acute myocardial infarction, cerebrovascular accident, etc.
• • Pregnant or lactating patients, or those of childbearing potential who do not take adequate contraceptive measures.
• • History of other malignancies, but no disease-free survival longer than 5 years.
• • Patients concurrently receiving other anti-tumor treatment or participating in other interventional clinical trials.
• • Patients who are unable to comply with this study for psychological, family or social reasons.
• • Patients with other serious diseases that the investigator considers not suitable.