mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer — FIND  

Advanced/Metastatic Colorectal Cancer Clinical Trial

Official title: mFOLFOX6 Combined With Dalpiciclib(SHR6390) in Patients With Metastatic Colorectal Cancer (FIND): A Single-arm, Phase IIa Study.

Status Recruiting

Clinical Trial Summary

This is an prospective, single-center, single-arm, Simon's two-stage design, phase IIa study for advanced/metastatic colorectal cancer (CRC) who had failed or were intolerant to standard treatment. This study aims to evaluate the safety and efficacy of mFOLFOX6 combined with dalpiciclib (SHR6390) in the treatment of advanced/metastatic colorectal cancer.

Clinical Trial Description

1. Primary study end point:

To evaluate the safety and objective response rate (ORR) of mFOLFOX6 combined with dalpiciclib (SHR6390) in patients with advanced/metastatic colorectal cancer who had failed or were intolerant to standard treatment.

2. Secondary study end Point:

To evaluate the progression-free survival (PFS) and overall survival (OS) of mFOLFOX6 combined with dalpiciclib (SHR6390) in patients with advanced/metastatic colorectal cancer who had failed or were intolerant to standard treatment. ;

Related Conditions & MeSH terms

• Advanced/Metastatic Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT05480280
• Study type: Interventional
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiaojian Wu, Ph.D
• Phone: +86-13760608396
• Email: wuxjian@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: July 20, 2022
• Completion date: December 2023