NCT06669377 TACE Combined With ICIs Plus MTT After 125I Irradiation Stent Placement in HCC With Main PVTT.
| NCT ID | NCT06669377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongda Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 444 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 444 participants in total. It began in 2024-01-01 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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: 1. 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.
Contact & Investigator
Gaojun Teng, M.D.
PRINCIPAL INVESTIGATOR
Zhongda Hospital
Frequently Asked Questions
Who can join the NCT06669377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06669377 currently recruiting?
Yes, NCT06669377 is actively recruiting participants. Contact the research team at lujian43307131@126.com for enrollment information.
Where is the NCT06669377 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06669377 clinical trial?
NCT06669377 is sponsored by Zhongda Hospital. The principal investigator is Gaojun Teng, M.D. at Zhongda Hospital. The trial plans to enroll 444 participants.
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