Trials / Not Yet Recruiting
Not Yet RecruitingNCT06089382
A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
A Phase III Trial of Sintilimab Plus Lenvatinib in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- Tongji Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sintilimab | IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence） |
| DRUG | Lenvatinib | 8mg orally once a day for 1 year |
| PROCEDURE | Transarterial Chemoembolization (TACE) | One cycle of TACE postoperatively |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2024-11-01
- Completion
- 2026-11-01
- First posted
- 2023-10-18
- Last updated
- 2023-10-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06089382. Inclusion in this directory is not an endorsement.