Thermal Ablation Followed by Immunotherapy for HCC
NCT03864211 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2022-09-29
Summary
The purpose of this study is to determine the safety and efficacy of immunotherapy toripalimab (anti-PD-1 mAb) combined with thermal ablation in patients with Hepatocellular Carcinoma (HCC).
Conditions
- Hepatocellular Carcinoma Non-resectable
Interventions
- PROCEDURE
-
Thermal ablation
Radiofrequency ablation or microwave ablation is performed under CT or ultrasound guidance for one to five target lesions.
- DRUG
-
Toripalimab
Protocol 1. Patients received toripalimab (240mg, Q3W) as monotherapy. Protocol 2. Patients received toripalimab (240mg, Q3W) on day 3 after ablation. Protocol 3. Patients received toripalimab (240mg, Q3W) on day 14 after ablation.
Sponsors & Collaborators
-
Xiangya Hospital of Central South University
lead OTHER
Principal Investigators
-
Liangrong Shi, M.D. · Xiangya Hospital of Central South University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-15
- Primary Completion
- 2023-05-30
- Completion
- 2023-05-30
Countries
- China
Study Locations
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