NCT05342194View on ClinicalTrials.gov

Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study

PHASE3RecruitingINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

June 19, 2023

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Intrahepatic Cholangiocarcinoma
Interventions
DRUG

Toripalimab

240 mg IV on day 1 of each 21-day treatment cycle (Q3W) for up to 35 treatment cycles

DRUG

Lenvatinib mesylate capsules

8 mg orally (po) once daily (QD)

DRUG

Placebo IV

Placebo IV on day 1 of each 21-day treatment cycle (Q3W) for up to 35 treatment cycles

DRUG

Oral placebo

Oral placebo po QD continuously

DRUG

Oxaliplatin for injection

85 mg/m2 IV, on day 1 of each 21-day treatment cycle (Q3W) up to 8 cycles

DRUG

Gemcitabine hydrochloride

1 g/m2 IV, on day 1 and day8 of each 21-day treatment cycle (Q3W) up to 8 cycles

DRUG

Cisplatin

25 mg/m2 IV, on day 1 and day8 of each 21-day treatment cycle (Q3W) up to 8 cycles

Trial Locations (1)

130061

RECRUITING

Zhongshan Hospital affiliated to Fudan University, Shanghai

All Listed Sponsors
lead

Shanghai Junshi Bioscience Co., Ltd.

OTHER