Clinical trial · Interventional
Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
NCT05444088CI-TRIAL-00078143unknownPhase 1 / Phase 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)
To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced 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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| SHR-8068 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Adebrelimab in combination with Bevacizumab
- interventionNames
- Drug: Adebrelimab
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1
- interventionNames
- Drug: Adebrelimab
- Drug: Bevacizumab
- Drug: SHR-8068
- type
- EXPERIMENTAL
- label
- Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2
- interventionNames
- Drug: Adebrelimab
- Drug: Bevacizumab
- Drug: SHR-8068
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, both male and female; 2. Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment; 3. Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment; 4. At least one measurable lesion based on RECIST v1.1 criteria; 5. Barcelona clinic liver cancer: Stage B or C; 6. ECOG PS score: 0-1 points; 7. Child-Pugh score: ≤ 7; 8. Expected survival period ≥ 3 months; 9. Adequate organ function. Exclusion Criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; 2. Patients with any active, known or suspected autoimmune disorder; 3. Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose; 4. With known severe allergic reactions to any other monoclonal antibodies; 5. Patients with known CNS metastasis or hepatic encephalopathy; 6. Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation; 7. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose; 8. Patients with other malignancies currently or within the past 5 years; 9. Patients with hypertension which cannot be well controlled by antihypertensives; 10. Uncontrolled cardiac diseases or symptoms; 11. Patients with other potential factors that may affect the study results.
References
Publications (0)
Data not yet available
No reference posted for this study.