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Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT05111860•Shanghai Minimally Invasive Surgery Center

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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;

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 1, 2022

Primary Completion Date

August 1, 2024

Completion Date

August 1, 2025

Last Updated

March 7, 2024

Enrollment

ESTIMATED participants

Conditions

Neoadjuvant TreatmentRectal CancerBevacizumabRadiotherapy

Interventions

Bevacizumab+mFOLFOX6

DRUG

Contacts

Zhenghao Cai, MD

CONTACT

+862164458887 c3z2h1@alumni.sjtu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy

Inclusion Criteria

Exclusion Criteria

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