RecruitingNot Applicable

TACE Combined With ICIs Plus MTT After 125I Irradiation Stent Placement in HCC With Main PVTT.

China444 participantsStarted 2024-01-01

Plain-language summary

Hepatocellular carcinoma (HCC) patients with Vp4 \[main trunk\] portal vein tumor thrombosis (PVTT) face a significantly poor prognosis, and current treatment options provide limited benefits. We aimed to assess the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) after irradiation stent placement (ISP) as first line treatment for HCC patients with Vp4 PVTT.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. age ≥18 years old; (2) diagnosis of HCC is confirmed through histological or cytological analysis, as well as clinical features; (3) histologically confirmed or imaging-diagnosed PVTT extending to the main portal vein (Vp4); (4) including at least one measurable intrahepatic lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; (5) Eastern Cooperative Oncology Group (ECOG) performance status of ≤2; (6) patients received first-line treatment with either ICIs-MTT or an ISP-containing quadruple combination within eight weeks (In the ICIs-MTT group, MTT was administered alongside ICIs. In the ISP-containing quadruple, TIT and ICIs-MTT were given after stent placement and portal vein recanalization, either simultaneously or within eight weeks before or after the ICIs-MTT therapy).

Exclusion criteria

✕. patients with extrahepatic metastases; (2) a history of or concurrent malignancies; (3) patients underwent prior systemic treatments or locoregional therapies, including surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection, and cryoablation, within three months before the initiation of ISP.; (4) Child-Pugh grade C liver function, a Child-Pugh score of 3 for ascites, or the presence of overt hepatic encephalopathy; (5) incomplete outcome data or missing essential baseline factors for analysis.

What they're measuring

Overall Survival (OS)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT06669377

SponsorZhongda Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-31

Contact for this trial

Jian Lu, M.D.

+86-15850654644 lujian43307131@126.com

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