Clinical trial · Interventional
HAIC Combine Tislelizumab and Lenvatinib in the Treatment of HCC With Type IV (Vp4) Portal Vein Tumor Thrombus (HAI-TL)
The Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Tislelizumab and Lenvatinib in the Treatment of Hepatocellular Carcinoma (HCC) With Type IV(Vp4) Portal Vein Tumor Thrombus (PVTT): A Prospective, Single-armed, Stage II Clinical Trial
NCT06210334CI-TRIAL-00074171HAI-TLunknownPhase 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 estimate the safety and efficacy of hepatic artery infusion chemotherapy (HAIC) combine Tislelizumab and Lenvatinib (HAI-TIS-LEN) in the Treatment of hepatocellular carcinoma (HCC) with type IV(Vp4) portal vein tumor thrombus (PVTT).
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 With PVTT | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HAIC combined with Tislelizumab and Lenvatinib (HAI-TIS-LEN) group
- description
- HAIC with modified FOLFOX (oxaliplatin, 85 mg/ m2, leucovorin 400 mg/ m2, 5-fluorouracil bolus 400 mg/m2 on day 1; and 5-fluorouracil infusion 2400 mg/ m2 for 46 h) on day1-2 every 3 weeks. Tislelizumab injection intravenously after 24h of HAIC every 3 week. Lenvatinib 12/8 mg (weight ≥ 60 kg/\< 60 kg) orally once daily starting 1-3 days after HAIC.
- interventionNames
- Drug: Tislelizumab
- Drug: Lenvatinib
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From the date of treatment initiation until the date of death from any cause, assessed up to 60 months.
- description
- Duration from the date of initial HAI-TIS-LEN treatment to the date of death due to any cause.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically, cytologically, or clinically confirmed diagnosis of hepatocellular carcinoma (HCC). 2. Age between 18 and 75 years. 3. Presence of type 4 portal vein tumor thrombosis (PVTT). 4. Child-Pugh A or B liver function. 5. Eastern Cooperative Group performance status (ECOG) score of 0-2. 6. Satisfactory blood, liver, and kidney function parameters, including: * (a) Hemoglobin concentration ≥ 8.5 g/dL, neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 40 × 10\^9/L. * (b) Serum albumin concentration ≥ 30 g/L, bilirubin ≤ 50 μmol/L, AST and ALT \< 5 × upper limit of normal (ULN), and alkaline phosphatase \< 4 × ULN. * (c) Extended prothrombin time \< 6 seconds of ULN. * (d) Serum creatinine \< 1.5 × ULN. 7. Ability to comprehend the protocol and provide informed consent by signing a written document. Exclusion Criteria: 1. History of a second primary malignant tumor. 2. Severe dysfunction of the heart, kidneys, or other organs. 3. Evidence of hepatic decompensation, including ascites, active gastrointestinal bleeding, or hepatic encephalopathy. 4. Pregnancy or lactation. 5. Known history of HIV. 6. History of organ allograft. 7. Known or suspected allergy to investigational agents or any agent administered in conjunction with this trial. 8. Active gastric or duodenal ulcers within 3 months before enrollment. 9. Incomplete medical data or loss to follow-up.
References
Publications (6)
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- BACKGROUNDThomas MB, Jaffe D, Choti MM, Belghiti J, Curley S, Fong Y, Gores G, Kerlan R, Merle P, O'Neil B, Poon R, Schwartz L, Tepper J, Yao F, Haller D, Mooney M, Venook A. Hepatocellular carcinoma: consensus recommendations of the National Cancer Institute Clinical Trials Planning Meeting. J Clin Oncol. 2010 Sep 1;28(25):3994-4005. doi: 10.1200/JCO.2010.28.7805. Epub 2010 Aug 2. PMID 20679622
- BACKGROUNDFinn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745. PMID 32402160
- BACKGROUNDRen Z, Xu J, Bai Y, Xu A, Cang S, Du C, Li Q, Lu Y, Chen Y, Guo Y, Chen Z, Liu B, Jia W, Wu J, Wang J, Shao G, Zhang B, Shan Y, Meng Z, Wu J, Gu S, Yang W, Liu C, Shi X, Gao Z, Yin T, Cui J, Huang M, Xing B, Mao Y, Teng G, Qin Y, Wang J, Xia F, Yin G, Yang Y, Chen M, Wang Y, Zhou H, Fan J; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study. Lancet Oncol. 2021 Jul;22(7):977-990. doi: 10.1016/S1470-2045(21)00252-7. Epub 2021 Jun 15.