Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC
NCT05992584 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-09-14
Summary
This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
Conditions
Interventions
- DRUG
-
Lenvatinib, sintilimab plus SIRT
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Sponsors & Collaborators
-
Second Affiliated Hospital of Guangzhou Medical University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-10
- Primary Completion
- 2026-01-09
- Completion
- 2026-08-09
Countries
- China
Study Locations
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