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

Phase

N/A

Condition

Colorectal Cancer

Digestive System Neoplasms

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT03245203

20170801001

Ages 18-70
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

1. Clinical stage II or stage III rectal cancer patients diagnosed by preoperativebiopsy pathology report, endoscopic examination report and preoperative abdominalpelvic dynamic contrast enhanced-MRI examination (DCE-MRI); 2. Primary tumor lesionswithin 4~12 cm from the anus through endoscopic examination; 3. No distant metastasisand intestinal obstruction; 4. No surgical contraindications; 5. Can be treated withneoadjuvant chemotherapy confirmed by normal routine examination; 6. informed consentwith patients and family members before treatment.

Exclusion

Exclusion Criteria:

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

Study Design

August 01, 2017

August 31, 2020

Study 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.

Connect with a study center

First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing 100048
China
Site Not Available

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