Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer

Advanced Colorectal Cancer Clinical Trial

Official title: Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer

Status Not yet recruiting

Clinical Trial Summary

This study is a single-arm, prospective, open-label observational clinical study to evaluate the efficacy and safety of Bevacizumab combined with Oxaliplatin and TAS-102 in patients with advanced unresectable rectal cancer.

Clinical Trial Description

Eligible subjects received Bevacizumab in combination with Oxaliplatin and the TAS-102 investigational drug, and Bevacizumab and Oxaliplatin were administered intravenously on day 1 of each cycle. Medicine, every 14 days as a course of treatment, TAS-102 orally administered, 35mg/m2 (maximum single dose 80mg), bid, orally on the 1st to 5th days, 2 weeks as a course of treatment.

Patients were treated until objective disease progression, worsening symptoms, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. Clinicians will comprehensively evaluate according to clinical treatment guidelines and clinical practice treatment principles. For patients who still benefit after progression, the investigator can decide whether to continue the treatment with Bevacizumab combined with Oxaliplatin and TAS-102. Efficacy objectives were assessed after all subjects completed treatment/termination visits. Subjects were assessed for safety throughout the study period through laboratory tests and adverse event reporting. ;

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT05364489
• Study type: Interventional
• Source: The First Affiliated Hospital of Zhengzhou University
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 15, 2022
• Completion date: June 15, 2027