NCT04734249

Second-line Surufatinib Combined With Chemotherapy in Advanced CRC

A Multi-cohort and Controlled Study to Evaluate the Efficacy and Safety of Surufatinib Combined With Chemotherapy as Second-line Treatment of Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A phase II, muti-cohort study to assess the efficacy and safety of Surufatinib combined with chemotherapy as a second-line treatment in patients with advanced CRC

Detailed description

This study adopt Simon's two-stage minimax designs method based on the primary endpoint of objective response rates. In each arm, 15 patients were planned for the first stage. If two or more responses were observed, an additional 13 patients were to be accrued for a total of 28 patients. If 7 or more of the 28 patients in an arm achieved an objective response, then that arm was designated worthy of additional investigation. Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) , Cohort 1 :Surufatinib+mFOLFOX6/FOLFIRI,Cohort 2 :Surufatinib+FOLFOXIRI for every 14-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib(HMPL-012)	1. Cohort 1:Surufatinib(250mg ,qd,po)+mFOLFOX6/FOLFIRI,14 days for a cycle.The curative effect was evaluated every 4 cycles. Cohort 2:Surufatinib(250mg ,qd,po)+FOLFOXIRI,14 days for a cycle.The curative effect was evaluated every 4 cycles. 2. if the first-line chemotherapy was used FoLFOX ,the second-line is FOLFIRI,or the first-line chemotherapy was used FOLFIRI ,the second-line is FoLFOX. 3. Second-line Surufatinib Combined With Chemotherapy in Advanced CRC.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-03-01
• Completion: 2023-12-01
• First posted: 2021-02-02
• Last updated: 2021-02-02