Clinical trial · Interventional
Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC With Portal Vein Tumor Thrombosis
A Pilot Study to Evaluate the Safety and Efficacy of Radiotherapy Plus Sintilimab for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
NCT04104074CI-TRIAL-00045800unknownPhase 1ClinicalTrials.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 proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.
Conditions
Conditions (2)
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 |
| Portal Vein Tumor Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy Plus Sintilimab
- description
- HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment.
- interventionNames
- Radiation: Radiotherapy
- Drug: Sintilimab
Primary outcomes (1)
- measure
- Incidence of treatment-emergent adverse events
- timeFrame
- 1 year
- description
- Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria
Secondary outcomes (3)
- measure
- Overall response rate (ORR)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches) 3. Has at least 1 measurable lesion 4. Age ≥18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Adequate organ function 7. Child Pugh class A 8. Life expectancy ≥12 weeks. 9. Antiviral therapy per local standard of care for hepatitis B 10. Woman of child bearing potential must have a negative pregnancy test 11. Must use acceptable form of birth control while on study Exclusion Criteria: 1. Has previously been performed by raditotherapy for the area to be treated. 2. With extrahepatic metastasis 3. History of hepatic encephalopathy or liver transplantation 4. Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive 5. Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes 6. Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment 7. With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable 8. Evidence of active pulmonary tuberculosis (TB) 9. Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) 10. History of allergic reactions to related drugs
References
Publications (0)
Data not yet available
No reference posted for this study.