Lenvatinib in Combination With Camrelizumab as First-Line Therapy in Patients With Advanced HCC

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04443309
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab 200mg,iv,d1,q2w
  • Lenvatinib — DRUG
    Lenvatinib 8mg (\<60kg) or 12mg (≥60kg),po,d2,qd

Study Details

This is a single arm, open-label, non-randomized and single-center phase I/II clinical study, to evaluate the the safety, tolerance and efficacy of Lenvatinib plus Camrelizumab as first-line therapy in patients with advanced Hepatocellular Carcinoma.

Key Dates

Start date
Sep 11, 2020
Status verified
Jan 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib plus Camrelizumab
    Camrelizumab (Jiangsu HengRui Medicine Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody. Lenvatinib is a novel angiogenesis inhibitor which targets multiple tyrosine kinases， including vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: one year ]

Central Contacts

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