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)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05111860


Related Trials