Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy

Phase 1

Recruiting

• Conditions: Neoadjuvant Treatment; Rectal Cancer; Bevacizumab; Radiotherapy
• Interventions: Drug: Bevacizumab+mFOLFOX6

• Registration Number: NCT05111860
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-08
• Study Start: 2022-11-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	Bevacizumab+mFOLFOX6	-

Primary Outcome Measures

Name	Time	Method
Peri-operative complications	From the start of treatment to 3 months after surgery	Complications occurring in the perioperative period

Secondary Outcome Measures

Name	Time	Method
Pathological response rate	2 weeks after surgery	Tumor Regression Grade 0-1
Pathological complete response rate	2 weeks after surgery	Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0)
2-year local control rate	2 years	Refers to the probability of not finding local recurrence of tumor within 2 years，including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit.
2-year metastasis-free rate	2 years	Refers to the probability of no distant metastasis within 2 years
Overall survival	2 years	Refers to the time from the start of treatment to death due to any cause.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China