Clinical trial · Interventional
Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma
Sintilimab and Bevacizumab Combined With Radiotherapy in the Treatment of Advanced Hepatocellular Carcinoma
NCT05010434CI-TRIAL-00069791unknownPhase 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)
The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.
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 |
|---|---|---|---|
| Sintilimab and Bevacizumab Combined with Radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sintilimab and Bevacizumab Combined with Radiotherapy
- interventionNames
- Drug: Sintilimab and Bevacizumab Combined with Radiotherapy
Primary outcomes (1)
- measure
- ORR (objective response rate)
- timeFrame
- through study completion, up to 2 year
- description
- the proportion of patients who have a partial or complete response to therapy.
Secondary outcomes (5)
- measure
- PFS (progression-free survival)
- timeFrame
- through study completion, up to 2 year
- description
- defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
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; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 3. Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment; 4. At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST); 5. Presented with Cheng's type I/II/III PVTT; 6. Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%; 7. Child-Pugh class A; 8. Adequate hematological, liver, renal function: 1. hemoglobin concentration ≥ 90 g/L; 2. neutrophil count ≥ 1.5×109/L; 3. platelet count ≥ 60×109/L; 4. AST and ALT ≤ 3×upper limit of normal (ULN) 5. total bilirubin ≤ 1.5×ULN; 6. serum creatinine ≤ 1.5×ULN; 7. serum albumin concentration ≥ 30 g/L; 9. Life expectancy of at least 3 months. Exclusion Criteria: 1. Tumor invasion of the superior mesenteric vein or bile ducts; 2. Infiltrative HCC; 3. Allergic to research reagents; 4. With other malignancies within 5 years; 5. With poorly controlled hypertension; 6. A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding; 7. A history of autoimmune disease; 8. Active infection requiring systemic treatments; 9. Severe bleeding; 10. With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy; 11. With other severe comorbidities.
References
Publications (1)
- DERIVEDZhu M, Liu Z, Chen S, Luo Z, Tu J, Qiao L, Wu J, Fan W, Peng Z. Sintilimab plus bevacizumab combined with radiotherapy as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A multicenter, single-arm, phase 2 study. Hepatology. 2024 Oct 1;80(4):807-815. doi: 10.1097/HEP.0000000000000776. Epub 2024 Feb 15. PMID 38358542