Camrelizumab in Combination With Apatinib in Advanced ICC: A Single-arm Phase II Study
- Sponsor
- Sun Yat-sen University
- Study ID
- NCT04454905
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Intrahepatic Cholangiocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Camrelizumab — DRUGCamrelizumab (Jiangsu HengRui Medicine Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.
- Apatinib — DRUGApatinib is a novel angiogenesis inhibitor vascular endothelial growth factor 2.
Study Details
This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with advanced intrahepatic cholangiocarcinoma (ICC).
Key Dates
- Start date
- Aug 1, 2020
- Status verified
- Apr 2023
- Primary completion
- Jul 1, 2024
- Completion
- Jul 1, 2025
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Camrelizumab combination with ApatinibCamrelizumab 200mg, every 3 weeks, intravenous infused. Apatinib 250mg, once a day, orally. Until progression or unacceptable toxicity events develop.
Primary Outcome Measure
Progression-free Survival (PFS) [ Time Frame: Three years ]
Central Contacts
- Li Xu, MD., PhD.+862087343582
- Zhishan Lin862087343437
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