RecruitingNCT06561399

Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)

A Single-arm, Phase II, Prospective Study of Transcatheter Arterial Chemoembolization, Lenvatinib Combination With Sintilimab Sequential Radiotherapy in Patients With Initial Unresectable Hepatocellular Carcinoma


Sponsor

Fujian Provincial Hospital

Enrollment

28 participants

Start Date

Aug 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding precision radiotherapy (stereotactic body radiotherapy) to a combination of liver-directed treatment (TACE), targeted therapy (lenvatinib), and immunotherapy (sintilimab) can help control previously inoperable liver cancer that has partially responded to the initial combination treatment. **You may be eligible if...** - You are aged 18–75 with unresectable liver cancer (hepatocellular carcinoma) - After 2 months of treatment with TACE plus lenvatinib plus sintilimab, your cancer showed a partial response or stable disease - You have 1–3 remaining active liver lesions suitable for radiation - Your liver function is good (Child-Pugh class A) - You have not received prior targeted therapy or immunotherapy before this study **You may NOT be eligible if...** - Your cancer progressed or completely resolved on the initial treatment - Your cancer has spread outside the liver or into the inferior vena cava - You have an active autoimmune disease or are immunosuppressed - You are pregnant or breastfeeding - You have significant bleeding tendencies or serious heart or lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTTACE, Lenvatinib combination with Sintilimab sequential radiotherapy

TACE, Lenvatinib \[8mg(\<60kg)/12mg(\>60kg) orally daily\] combination with Sintilimab (200mg administered intravenous injection on Day 1 of each 21-day cycle) for 2 months. Sequential radiotherapy method and dosage are comprehensively evaluated by radiologists, hepatobiliary surgeons, and oncologists, and discussed by a multidisciplinary team


Locations(4)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

Fujian provincial hospital

Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT06561399


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