Efficacy and Safety of Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy for RAS Mutant-type Locally Advanced Rectal Cancer

Shanghai Minimally Invasive Surgery Center1 site in 1 country20 target enrollmentNovember 1, 2022

ConditionsNeoadjuvant Treatment Rectal Cancer Bevacizumab Radiotherapy

InterventionsBevacizumab+mFOLFOX6

DrugsBevacizumab+mFOLFOX6

Overview

Phase: Phase 1
Intervention: Bevacizumab+mFOLFOX6
Conditions: Neoadjuvant Treatment
Sponsor: Shanghai Minimally Invasive Surgery Center
Enrollment: 20
Locations: 1
Primary Endpoint: Peri-operative complications
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

November 1, 2022

End Date

August 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Minimally Invasive Surgery Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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;