Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)

Recruiting now

Conditions studied: Hepatocellular Carcinoma

In brief

This is a multicenter, Single-arm, Real-world Study to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with Tislelizumab (Triple Therapy) for patients with Hepatocellular Carcinoma (HCC) with bile duct tumor thrombus (BDTT).

Key facts

Study ID

NCT06602011

Run by

Fujian Provincial Hospital

People needed

20

Starts

2024-09-30

Expected to finish

2028-10-01

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 75 years old;
• Patients with clinical diagnosis of Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT) (refer to the diagnostic criteria of the Chinese Expert Consensus on Multidisciplinary Diagnosis and Treatment of HCC with BDTT (2020 Edition)), BCLC Stage B or Stage C, and unresectable HCC (decided after multidisciplinary discussion);
• Patients who had not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;
• Patients with at least one measurable lesion according to the mRECIST criteria (measurable lesion with a CT/MRI scan length diameter ≥ 10 mm and measurable lesion has not received localized treatment such as TACE, radiofrequency, cryotherapy, etc.);
• ECOG score: 0-1;
• liver function Child-Pugh class A or B; if combined with obstructive jaundice, total bilirubin ≤50umol/L is required. If higher than 50umol/L, biliary drainage is recommended;
• Blood routine: absolute neutrophil count ≥1.5×10\^9/L, Hb≥8.5g/L, PLT≥75×10\^9/L;
• No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance >40mL/min;
• Expected survival time greater than 3 months.

You may not qualify if…

• The tumor with extrahepatic metastasis or invaded adjacent organs;
• Patients received other anti-tumor treatments;
• Existence of contraindications to TACE;
• History of allergy to the components or excipients of Lenvatinib or Tislelizumab;
• The patient has any active autoimmune disease or has an autoimmune disease with expected relapse. Patients are on immunosuppressive or systemic hormone therapy for immunosuppression;
• Patients with proteinuria suggestive of ≥ 1 + in routine urine will undergo a 24-hour urine protein test for patients with ≥ 1 g of 24-hour urine protein;
• Patients with co-morbidities of other malignant tumors;
• Patients with co-morbid psychiatric disorders;
• Patients with pregnant or lactating women;
• Patients with organ transplant patients;
• Patients with hypothyroidism or hyperthyroidism.

Where it is running

• Fujian Provincial Hospital — Fuzhou, Fujian, China (enrolling)
• First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
• Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China
• Zhongshan Hospital of Xiamen University — Xiamen, Fujian, China
• First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• Zhangzhou Affiliated Hospital of Fujian Medical University — Zhangzhou, Fujian, China

Full record on ClinicalTrials.gov

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