HAIC or Lenvatinib Combined With Sintilimab for High Recurrence Risk Resectable Solitary Hepatocellular Carcinoma
NCT05621499 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2022-11-18
Summary
To evaluate the safety and efficacy of HAIC or Lenvatinib combined with Sintilimab as a neoadjuvant therapy for high recurrence risk resectable stage IB solitary hepatocellular carcinoma
Conditions
Interventions
- DRUG
-
HAIC
Oxaliplatin 85 mg/m2, LV 400 mg/ m2, 5-FU 400 mg/m2 bolus and then 2400 mg/m2 as 46h continuous infusion,Q3W,a total of 2 cycles
- DRUG
-
Sintilimab
200mg,iv,d1,q3w,a total of 3 cycles
- DRUG
-
12 or 8mg/kg,po,qd,a total of 3 cycles
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
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
- 2022-11-30
- Primary Completion
- 2023-11-30
- Completion
- 2025-11-30
Countries
- China
Study Locations
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