Durvalumab Plus Lenvatinib as First-line Treatment for Unresectable Hepatocellular Carcinoma

Sponsor
Zhejiang University
Study ID
NCT05312216
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab plus Lenvatinib — DRUG
    Durvalumab: 1500mg, iv.drip, Q4w Lenvatinib: 8mg, QD (body weight \< 60kg) or 12mg, QD (body weight ≥ 60kg) Number of cycle: until subjects withdrawing the informed consent OR progressive disease OR developing unacceptable toxicity events

Study Details

This is a phase II, open-label study to evaluate the efficacy and safety of Durvalumab plus Lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma.

Key Dates

Start date
Apr 30, 2023
Status verified
Jan 2023
Primary completion
Mar 31, 2024
Completion
Jun 30, 2024

Study Design

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

Arms

  • Experimental: Durvalumab plus Lenvatinib
    Durvalumab is a human IgG1 κ monoclonal antibody that inhibits binding of PD-L1 to its receptors PD-1 and CD80. Lenvatinib is a multi- kinase inhibitor of VEGF receptors 1 to 3, FGF receptors 1 to 4, PDGFRa, RET, and KIT.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up o one year ]

Central Contacts

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