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Toripalimab, Lenvatinib, and GEMOX Neoadjuvant for Resectable ICC
NCT04506281Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2020
- Primary completion
- Aug 2021
- Countries
- 1
- Sponsor
- Zhongshan Hospital, Fudan University
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- toripalimab
- Conditions
- intrahepatic cholangiocarcinoma (ICC)
01
Overview
Phase 2, randomised, open-label trial of toripalimab in intrahepatic cholangiocarcinoma (ICC) (2 arms), sponsored by Zhongshan Hospital, Fudan University. Primary endpoint: Event-free survival at 18 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Neoadjuvant treatment
Toripalimab + Lenvatinib + GEMOX followed by Surgery and Adjuvant Capecitabine
Traditional group
Surgery followed by Adjuvant Capecitabine
03
Who it enrols
Patients with resectable intrahepatic cholangiocarcinoma and high-risk recurrence factors (tumor > 5cm, vascular invasion, multiple nodules, hilar LN metastasis, or CA199 > 200 U/ml). Must have adequate organ function and no prior systemic therapy.
04
Endpoints
Primary
Event-free survival
Secondary
Overall survival
Objective response rate
Pathological remission rate
Adverse events
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