Clinical trial · Observational
HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC
NCT06632093CI-TRIAL-00081366recruitingClinicalTrials.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 evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCLC Stage B Hepatocellular Carcinoma | BCLC Stage B Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| BCLC Stage C Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatic Arterial Infusion Chemotherapy | — | UNRESOLVED | — |
| Lenvatinib | — | UNRESOLVED | — |
| PD-1 | — | UNRESOLVED | — |
| Systemic Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hepatic artery infusion chemotherapy | Procedure | — | UNRESOLVED |
| Lenvatinib + PD-1 monoclonal antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HAIC plus Lenvatinib and PD-1 inhibitors
- description
- Each patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks.
- interventionNames
- Procedure: hepatic artery infusion chemotherapy
- Drug: Lenvatinib + PD-1 monoclonal antibody
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Up to approximately 2 years
- description
- The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Secondary outcomes (8)
- measure
- Progression free survival(PFS) (Overall)
- timeFrame
- Up to approximately 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 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 received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed; 4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval; 5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment; 6. Received at least 2 cycles of HAIC； 7. Has repeated measurable intrahepatic lesions; 8. Child-Pugh class A or B. Exclusion Criteria: 1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months; 2. With other malignant tumors; 3. Unable to meet criteria of combination timeframe described above.
References
Publications (0)
Data not yet available
No reference posted for this study.