Clinical trial · Interventional
A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
A Phase III, Randomized, Double-blind, Multicenter Study of SHR-8068 and Adebrelimab Plus Bevacizumab in Combination With TACE in Participants With Incurable Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma. Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
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 |
|---|---|---|---|
| SHR-8068 + Adebrelimab + Bevacizumab | Drug | — | UNRESOLVED |
| SHR-8068 Placebo + Adebrelimab + Bevacizumab | Drug | — | UNRESOLVED |
| SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment group A
- description
- SHR-8068 + Adebrelimab + Bevacizumab + Transarterial Chemoembolization (TACE)
- interventionNames
- Drug: SHR-8068 + Adebrelimab + Bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- Treatment group B
- description
- SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo + Transarterial Chemoembolization (TACE)
- interventionNames
- Drug: SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo
- type
- EXPERIMENTAL
- label
- Treatment group C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years old, male or female; 2. Diagnosis confirmed HCC by pathologically or clinically; 3. At least one measurable lesion; 4. Child-Pugh liver function grade A; 5. ECOG-PS score: 0 or 1; 6. Eligible for TACE treatment as assessed by the investigator; 7. Participants with HBV or HCV infection must be on and remain on standard antiviral therapy throughout the study period; 8. Consent to contraception. Exclusion Criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years; 2. Participants with any active, known or suspected autoimmune disorder; 3. Participants with hypertension which cannot be well controlled by antihypertensives; 4. Uncontrolled cardiac diseases or symptoms; 5. Participants with hepatic encephalopathy; 6. Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment; 7. History of gastrointestinal perforation and/or fistula; 8. Participants with other potential factors that may affect the study results.
References
Publications (0)
Data not yet available