Clinical trial · Observational
HAIC in Combination with Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors for Advanced HCC
In Which Tumor Burden Range Does Advanced Hepatocellular Carcinoma Patients Benefit More from Hepatic Arterial Infusion Chemotherapy Plus Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors Than Immune Checkpoint Inhibitors Plus Tyrosine Kinase Inhibitors? a Multi-center, Retrospective, Propensity Score Matching Study
- 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 evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Arterial Infusion Chemotherapy | — | UNRESOLVED | — |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Tyrosine Kinase Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hepatic artery infusion chemotherapy | Procedure | — | UNRESOLVED |
| Immune Checkpoint Inhibitors | Drug | — | UNRESOLVED |
| Tyrosine kinase inhibitor (TKIs) | Drug | Tyrosine Kinase Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- HAIC plus TKIs and ICIs
- description
- Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks.
- interventionNames
- Procedure: hepatic artery infusion chemotherapy
- Drug: Tyrosine kinase inhibitor (TKIs)
- Drug: Immune Checkpoint Inhibitors
- label
- TKIs plus ICIs
- description
- Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks.
- interventionNames
- Drug: Tyrosine kinase inhibitor (TKIs)
- Drug: Immune Checkpoint Inhibitors
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Up to approximately 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus; 3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy); 4. Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval; 5. HAIC was performed after the first TKIs/ ICIs treatment or before treatment; 6. Received at least 2 cycles of HAIC or ICIs treatments； 7. Has repeated measurable intrahepatic lesions; 8. Child-Pugh class A or B. Exclusion Criteria: 1. Patients who took systemic anti-tumor treatments before the combination therapy; 2. With other malignant tumors; 3. Unable to meet criteria of combination timeframe described above.
References
Publications (0)
Data not yet available