Clinical trial · Interventional
Tislelizumab in Combination With TACE in Advanced Hepatocellular Carcinoma
A Multicentric, Open-Label Study to Evaluate Tislelizumab in Combination With Transarterial Chemoembolization as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT04652492CI-TRIAL-00048621unknownPhase 2ClinicalTrials.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)
A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab in combination with cTACE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab in combination with cTACE
- description
- Tislelizumab in combination with on-demanded cTACE
- interventionNames
- Drug: Tislelizumab in combination with cTACE
Primary outcomes (1)
- measure
- TTP assessed by independent review committee(IRC)
- timeFrame
- up to 24 months after enrollment or study close
- description
- Defined as the time from the date of first cTACE to the date of first documentation of disease progression per mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).
Secondary outcomes (7)
- measure
- TTP assessed by investigators
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18-70 years old on the day the patients voluntary to participate in the study and signing in ICF. 2. Histological or clinical diagnosis of HCC. 3. BCLC stage C patients ineligible for surgical resection or liver transplantation. 4. No prior systemic therapy for HCC (including immunotherapy). 5. Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST. 6. Child-Pugh A-B7. 7. ECOG PS 0-1. 8. Adequate hematological function (absolute neutrophil count ≥ 1.5 X 109/L, platelets count≥50 X109/L, and hemoglobin ≥85 g/L); Adequate hepatic function (both AST and ALT ≤ 3 ULN, serum total bilirubin ≤ 34.2 umol/L or 2mg/dl, serum albumin ≥ 29g/L); Adequate renal function (eGFR \> 30 ml/min/1.73 m2) 9. For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable. 10. life expectancy of more than 3 months. 11. Patients must be able to understand and willing to sign a written informed consent document. 12. Patients suitable for TACE therapy assessed by investigators. Exclusion Criteria: 1. Tumor thrombus involving main trunk of portal vein or inferior vena cava. 2. Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer. 3. Disease history of grade 2 or more hepatic encephalopathy. 4. Extrahepatic metastasis on baseline imaging. 5. HIV infection or syphilis. 6. Prior therapies with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 agents. 7. Tumor diffuse.
References
Publications (0)
Data not yet available
No reference posted for this study.