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CNClinicalTrials.govClinical trialPhase 2Recruiting

Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT

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Official record

Identifier
NCT06904183
Recruiting locations

country

China
Interventions studied
LEN+SIN+DEB-TACE+HAICLEN+SIN+DEB-TACE
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
Target enrolment
320 participants
Study type
INTERVENTIONAL
Phase
Phase 2
Status
Recruiting
First posted
Apr 1, 2025
Last updated on the registry
Aug 11, 2026
Age
18 Years – 75 Years
Sex
ALL
Study contact
The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.
Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* a confirmed diagnosis of HCC
* the largest intrahepatic lesion \>7 cm
* presence of PVTT on imaging
* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
* Eastern Cooperative Oncology Group performance status ≤1
* Child-Pugh class A/B
* adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds
* life expectancy of at least 3 months

Exclusion Criteria:

* accompanied with vena cava tumor thrombus
* central nervous system involvement
* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
* history of other malignancies
* uncontrollable infection
* history of HIV
* history of organ or cells transplantation
Indexed under
Liver Cancer