Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

Launched by SHANGHAI MINIMALLY INVASIVE SURGERY CENTER · Jun 6, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with locally advanced rectal cancer. The study is looking at the combination of a targeted therapy called cetuximab, chemotherapy (specifically mFOLFOX6), and short-term radiation therapy. The goal is to see how effective and safe this combination is for patients whose cancer has specific genetic characteristics (wild-type KRAS, NRAS, PI3KCA, and BRAF) and who have not had previous treatments for their cancer.

To participate in this trial, patients need to be between 18 and 75 years old and have a confirmed diagnosis of rectal adenocarcinoma. They should not have any serious health issues that would complicate treatment and must be in good overall health. Participants will receive the study treatment and will be monitored closely for any side effects and to determine how well the treatment is working. This trial is currently recruiting patients, so if you or someone you know might qualify, it could be a valuable opportunity to explore new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A biopsy proven histological diagnosis of rectal adenocarcinoma；
• • 2. An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type;
• • 3. No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
• • 4. MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
• • 5. Age between 18-75 years;
• • 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
• 7. Has sufficient organ function:
• • Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L, neutrophils ≥ 1.5 × 109/L
• • Liver function: ALT and AST \< 2.5 × ULN;
• • Renal function: serum creatinine \< 1.5 ULN;
• • 8. Willing to participate and informed consent signed；
• Exclusion Criteria:
• • 1. Patients with mutations in any of KRAS, NRAS, or BRAF, microsatellite instablility-High;
• • 2. Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;
• • 3. Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;
• • 4. Female patients who are pregnant or breastfeeding;
• • 5. Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;
• • 6. Patients with active infection;
• • 7. Poor overall health status, ECOG ≥ 2;
• • 8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;
• • 9. Known hypersensitivity reactions to any investigational drugs;