Clinical trial · Interventional
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study
NCT06089369CI-TRIAL-00076580not 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) for patients with hepatocellular carcinoma and microvascular invasion (MVI) 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 |
|---|---|---|---|
| Active surveillance | Other | — | UNRESOLVED |
| Sintilimab (18 cycles) | Drug | Sintilimab | ALIAS |
| Sintilimab (9 cycles) | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Sintilimab for six months group (9 cycles)
- description
- Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 9 cycles or until disease recurrence or intolerable adverse effects occurred.
- interventionNames
- Drug: Sintilimab (9 cycles)
- type
- EXPERIMENTAL
- label
- Sintilimab for one year group (18 cycles)
- description
- Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 18 cycles or until disease recurrence or intolerable adverse effects occurred.
- interventionNames
- Drug: Sintilimab (18 cycles)
- type
- ACTIVE_COMPARATOR
- label
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 microvascular invasion (MVI) * Aged 18-75 years * No previous systematic treatment and locoregional therapy for HCC prior to randomization * Absence of major macrovascular invasion * 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 * Subjects with HCV- RNA (+) must receive antiviral therapy * 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 * Cardiac clinical symptom or cardiovascular disease that is not well controlled * 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.