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

> **NCT05342194** · PHASE3 · RECRUITING · sponsor: **Shanghai Junshi Bioscience Co., Ltd.** · enrollment: 480 (estimated)

## Conditions studied

- Intrahepatic Cholangiocarcinoma

## Interventions

- **DRUG:** Toripalimab
- **DRUG:** Lenvatinib mesylate capsules
- **DRUG:** Placebo IV
- **DRUG:** Oral placebo
- **DRUG:** Oxaliplatin for injection
- **DRUG:** Gemcitabine hydrochloride
- **DRUG:** Cisplatin

## Key facts

- **NCT ID:** NCT05342194
- **Lead sponsor:** Shanghai Junshi Bioscience Co., Ltd.
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-06-19
- **Primary completion:** 2027-05-31
- **Final completion:** 2027-05-31
- **Target enrollment:** 480 (ESTIMATED)
- **Last updated:** 2025-04-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05342194

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05342194, "Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT05342194. Licensed CC0.

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