Clinical trial · Interventional
The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC)
The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
NCT04961918CI-TRIAL-00052689unknownPhase 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)
To evaluate the efficacy of HAIC combine Lenvatinib and Durvalumab (HILL) in advanced HCC.
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 |
|---|---|---|---|
| Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)
- interventionNames
- Procedure: Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)
Primary outcomes (1)
- measure
- PFS
- timeFrame
- From date of randomization until the date of progression, assessed up to 36 months
- description
- progression-free survival
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- From date of randomization until the date of death, assessed up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * older than 18 years old and younger than 75 years; ECOG PS≤1; proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; cannot accepted hepatectomy; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent; Exclusion Criteria: * cannot tolerate HAIC or lenvatinib or durvalumab; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy;
References
Publications (1)
- DERIVEDLi SH, Zuo ZJ, Lu LH, Xu LZ, Wang QX, Zhao RC, Mei J, Li JB, Zheng L, Guo RP, Wei W. HILL: the efficacy and safety of hepatic arterial infusion chemotherapy with the FOLFOX regimen combined with lenvatinib and the PD-L1 inhibitor durvalumab in unresectable hepatocellular carcinoma: a prospective, single-arm, phase 2 clinical trial. Signal Transduct Target Ther. 2026 May 15;11(1):181. doi: 10.1038/s41392-026-02718-0. PMID 42135293