Clinical trial · Interventional
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
NCT06089382CI-TRIAL-00070581not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Sintilimab | Drug | Sintilimab | ALIAS |
| Transarterial Chemoembolization (TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sintilimab Plus Lenvatinib
- interventionNames
- Drug: Sintilimab
- Drug: Lenvatinib
- type
- ACTIVE_COMPARATOR
- label
- TACE(one cycle) + active surveillance
- interventionNames
- Procedure: Transarterial Chemoembolization (TACE)
Primary outcomes (1)
- measure
- Recurrence-Free Survival (RFS)
- timeFrame
- Randomization up to approximately 36 months
- description
- RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with a histopathological diagnosis of HCC * Undergone a curative resection * Pathologically confirmed HCC with portal vein tumor thrombus (PVTT) * Aged 18-75 years * No previous systematic treatment and locoregional therapy for HCC prior to randomization * No extrahepatic spread * Full recovery from Curative resection within 4 weeks prior to randomization * Child-Pugh: Grade A or B(7) * ECOG-PS score: 0 or 1 * Adequate organ function Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC * Any preoperative treatment for HCC including local and systemic therapy * Have received more than 1 cycle of adjuvant TACE following surgical resection * Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency * Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug * Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy * Active or history of autoimmune disease * Thrombosis or thromboembolic event within 6 months prior to the start of study treatment * Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months * Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment * Inability or refusal to comply with the treatment and monitoring
References
Publications (0)
Data not yet available
No reference posted for this study.