A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: FOLFIRI+beacizumab; Procedure: CRT

• Registration Number: NCT03245203
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to reduce the local recurrence rate, however, no improvement of distant metastasis rate was observed, and the incidence of postoperative local recurrence and distant metastasis can reach more than 25%. It is still a challenge for us to improve the RO resection rate of locally advanced rectal cancer and reduce the incidence of local recurrence and distant metastasis.

Detailed Description

Objective: compared with the postoperative adjuvant therapy, neoadjuvant chemotherapy has shown better compliance of LARC patients, and may be more effective in reducing the incidence of local recurrence and distant metastasis. This study used the anti-angiogenesis drugs beacizumab and chemotherapy in patients with LARC for neoadjuvant chemotherapy, and investigated the short-term efficacy to provide objective basis for the selection of neoadjuvant therapy.

Methods: 70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-07
• Last Update Submitted: 2017-08-07
• Study First Posted: 2017-08-10
• Last Update Posted: 2017-08-10
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 1. Clinical stage II or stage III rectal cancer patients diagnosed by preoperative biopsy pathology report, endoscopic examination report and preoperative abdominal pelvic dynamic contrast enhanced-MRI examination (DCE-MRI); 2. Primary tumor lesions within 4~12 cm from the anus through endoscopic examination; 3. No distant metastasis and intestinal obstruction; 4. No surgical contraindications; 5. Can be treated with neoadjuvant chemotherapy confirmed by normal routine examination; 6. informed consent with patients and family members before treatment.

Exclusion Criteria

• history of beacizumab allergy, being treated with other therapy important viscera dysfunction and severe heart disease, including congestive heart failure, arrhythmia beyond the control, long-term drug treatment of angina pectoris, heart valve disease, myocardial infarction, and resistant hypertension; infectious wound and uncontrollable history of mental illness; infectious sexual diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	FOLFIRI+beacizumab	beacizumab+ neoadjuvant chemotherapy (FOLFIRI+beacizumab)
Control group	CRT	neoadjuvant CRT for consecutive 5 weeks

Primary Outcome Measures

Name	Time	Method
R0 resection rate	3 years	percent

Secondary Outcome Measures

Name	Time	Method
disease-free survival (DFS)	3 years	year
overall survival (OS)	3 years	year
overall response rate (ORR)	3 years	percent

Trial Locations

Locations (1)

First Affiliated Hospital, Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China