Clinical trial · Interventional
A Study to Evaluate TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection
Official Title ICMJE A Phase 2, Open-Label, Multi-Center, Single Arm Study to Evaluate the Efficacy and Safety of TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection
- 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)
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Postoperative TACE + Tislelizumab 200mg IV Q3W
- description
- TACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab.
- interventionNames
- Drug: Tislelizumab
- Drug: TACE
Primary outcomes (1)
- measure
- 2-year Recurrence Free Survival Rate (2-year RFS rate)
- timeFrame
- Observation period 24 months
- description
- 2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with a histopathological or cytologically diagnosis of HCC * Subjects who have undergone a curative resection * High risk for HCC recurrence as protocol defined * No previous systematic treatment and locoregional therapy for HCC * Child-Pugh Score, Class A * ECOG performance status 0 or 1 * Full recovery from surgical resection * Adequate organ function * Absence of major macrovascular invasion * No extrahepatic spread * Life expectancy of at least 6 months Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC * Evidence of residual, recurrent, or metastatic disease * Known history of serious allergy to any monoclonal antibody * History of hepatic encephalopathy * Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein * Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment * Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment * Any active malignancy within 2 years prior to the start of treatment * Active or history of autoimmune disease * Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation * Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy * Pregnant or lactating women
References
Publications (0)
Data not yet available