: A Phase Ib/II Study To Evaluate Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

348

Participants

Timeline

Start Date

April 25, 2019

Primary Completion Date

November 15, 2023

Study Completion Date

December 16, 2024

Conditions
Advanced Solid Tumor
Interventions
DRUG

Fruquintinib in Combination with Sintilimab

"Fruquintinib plus Sintilimab:~Cohort A: Fruquintinib 3 mg QD, oral dosing, 3 weeks on/1 weeks off +Sintilimab 200mg Q4W, intravenous dosing.~Cohort B: Fruquintinib 4 mg QD, oral dosing, 3 weeks on/1 weeks off +Sintilimab 200mg Q4W, intravenous dosing~Cohort C: Fruquintinib 5 mg QD, oral dosing, 2weeks on/1 weeks off + Sintilimab 200mg Q3W, intravenous dosing~Cohort E: Fruquintinib 3 mg QD, continuous, oral dosing, + Sintilimab 200mg Q3W, intravenous dosing~Fruquintinib monotherapy arm:~Fruquintinib 5 mg QD, oral dosing, 3 weeks on/1 weeks off~Patients will be treated until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria."

Trial Locations (1)

201203

Shanghai East Hospital, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hutchmed

INDUSTRY

NCT03903705 - : A Phase Ib/II Study To Evaluate Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors | Biotech Hunter | Biotech Hunter