Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospectively Investigate the effectiveness and safety of neoadjuvant Bevacizumab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS mutant-type locally advanced rectal cancer

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Minimally Invasive Surgery Center
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

1. A biopsy proven histological diagnosis of rectal adenocarcinoma；

2. An ARMS-PCR proven KRAS, NRAS mutation, excluding BRAF mutation or microsatellite instablility-High;

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. An ARMS-PCR proven RAS wild type, BRAF mutation and 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;