RecruitingPhase 1Phase 2NCT05111860
Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy
Efficacy and Safety of Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy for RAS Mutant-type Locally Advanced Rectal Cancer
Sponsor
Shanghai Minimally Invasive Surgery Center
Enrollment
20 participants
Start Date
Nov 1, 2022
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria12
- A biopsy proven histological diagnosis of rectal adenocarcinoma;
- An ARMS-PCR proven KRAS, NRAS mutation, excluding BRAF mutation or microsatellite instablility-High;
- No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
- MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
- Age between 18-75 years;
- ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
- 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;
- Willing to participate and informed consent signed;
Exclusion Criteria9
- An ARMS-PCR proven RAS wild type, BRAF mutation and microsatellite instablility-High;
- Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;
- Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;
- Female patients who are pregnant or breastfeeding;
- Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;
- Patients with active infection;
- Poor overall health status, ECOG ≥ 2;
- Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;
- Known hypersensitivity reactions to any investigational drugs;
Interventions
DRUGBevacizumab+mFOLFOX6
Bevacizumab 5mg/kg d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05111860
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