Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy

NCT05111860 | Recruiting Phase 1

• 1 other identifier: MISC-Bev-SCRT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Peri-operative complications

  Complications occurring in the perioperative period

  From the start of treatment to 3 months after surgery

Secondary Outcomes (5)

• Pathological response rate

  2 weeks after surgery

• Pathological complete response rate

  2 weeks after surgery

• 2-year local control rate

  2 years

• 2-year metastasis-free rate

  2 years

• Overall survival

  2 years

Study Arms (1)

Group 1

EXPERIMENTAL

Drug: Bevacizumab+mFOLFOX6

Interventions

Bevacizumab+mFOLFOX6 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

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Zhenghao Cai, MD

CONTACT

+862164458887; c3z2h1@alumni.sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 8, 2021
• Study Start: November 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)