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

Plain Language Summary

Simplified for easier understanding

This study is testing bevacizumab (a drug that blocks tumor blood vessel growth) plus chemotherapy, followed by a short course of radiation, as a pre-surgery treatment for people with locally advanced rectal cancer that has specific gene mutations (KRAS or NRAS positive). **You may be eligible if...** - You are between 18 and 75 years old - You have biopsy-confirmed rectal cancer (adenocarcinoma) - Your tumor has KRAS or NRAS mutations, without BRAF mutations or high microsatellite instability - MRI confirms locally advanced disease (spread into surrounding tissue or nearby lymph nodes) - You have no intestinal obstruction and no distant spread detected on scans - You are in good general health (ECOG 0–1) with adequate organ function **You may NOT be eligible if...** - Your tumor has BRAF mutations or high microsatellite instability - Your cancer has spread to distant organs - You have intestinal obstruction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

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NCT05111860


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