Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy

NCT ID: NCT05111860

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-08-01

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

Conditions

Neoadjuvant Treatment; Rectal Cancer; Bevacizumab; Radiotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Group Type: EXPERIMENTAL

Bevacizumab+mFOLFOX6

Intervention Type: DRUG

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

Interventions

Bevacizumab+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

Intervention Type: DRUG

Eligibility Criteria

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;
• Renal function: serum creatinine < 1.5 ULN;

8. Willing to participate and informed consent signed；

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenghao Cai, MD

Role: CONTACT

c3z2h1@alumni.sjtu.edu.cn

+862164458887

Facility Contacts

Zhenghao Cai

Role: primary

c3z2h1@alumni.sjtu.edu.cn

+862164458887

Other Identifiers

MISC-Bev-SCRT

Identifier Type: -

Identifier Source: org_study_id