Clinical trial · Interventional
Radiotherapy + Sintilimab + Bevacizumab Biosimilar for uHCC With PVTT
An Exploratory Clinical Study of Radiotherapy Combined With Sintilimab Plus Bevacizumab Biosimilar in the Treatment of Unresectable Hepatocellular Carcinoma (uHCC) With Portal Vein Tumor Thrombus (PVTT)
- 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 study was a prospective, single-arm, single-center, phase II exploratory clinical study. To investigate the efficacy and safety of radiotherapy combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus.
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 Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy combined with sintilimab and bevacizumab biosimilar | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- radiotherapy combined with sintilimab and bevacizumab biosimilar
- interventionNames
- Combination Product: radiotherapy combined with sintilimab and bevacizumab biosimilar
Primary outcomes (1)
- measure
- Objective Response rate
- timeFrame
- up to 2 years from enrollment
- description
- assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Secondary outcomes (3)
- measure
- Objective Response rate, assessed according to the modified Response Evaluation Criteria
- timeFrame
- up to 2 years from enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Hepatocellular carcinoma confirmed by histology/cytology, or patients with cirrhosis and meet the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC 2. Child-pugh grade A or B (≤7 points) 3. A score of 0-1 according to the Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score); 4. Barcelona stage C; Inamicable for radical surgical resection or refusal of surgery without extra-hepatic metastases; Portal vein tumor thrombus (PVTT) was diagnosed by enhanced CT or enhanced MRI (type VP1 to VP3). 5. Had not received systemic therapy or radiotherapy before; Or disease progression after surgical resection or local treatment (without radiotherapy); 6. At least one measurable or evaluable lesion according to the response evaluation criteria for solid tumors, version 1.1 (RECIST V1.1); Or measurable lesions that had clearly progressed after local treatment (based on RECIST V1.1 criteria). 7. Patients with liver lesions and/or portal vein tumor thrombus lesions were treated with radiotherapy Exclusion Criteria: 1. Previous histological/cytological diagnosis included fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, and other components. 2. The area to be treated had been previously treated with radiotherapy 3. Patients with extrahepatic metastases 4. Patients with tumor thrombus invasion into the superior mesenteric vein 5. Patients with inferior vena cava tumor thrombus. 6. Central nervous system metastases were present. 7. A history of hepatic encephalopathy, or a history of liver transplantation. 8. There are clinical symptoms of pleural effusion, ascites, or pericardial effusion that require drainage. 9. Patients with acute or chronic active hepatitis B or C with hepatitis B virus (HBV) DNA\>2000IU/ml or 10\^4 Copies/ml; Hepatitis C virus (HCV)RNA\> 10\^3 Copies/ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody were both positive. 10. History of allergy to active ingredients and/or excipients of anti-PD-1 mab and anti-VEFG mab. 11. Other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix, were present within 5 years. 12. Bleeding events from esophageal or gastric fundus varices due to portal hypertension had occurred within the previous 6 months. Severe (G3) varicose veins were known to have been present on endoscopy within 3 months before the first dose. There was evidence of portal hypertension (including splenomegaly on imaging) and a high risk of bleeding as assessed by the investigator.
References
Publications (0)
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