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

Recruitingn/aAges 18 Years - 75 YearsAllFujian Provincial Hospital
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age between 18 and 75 years old; 2. 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); 3. Patients who had not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment; 4. Patients with at least one measurable lesion according to the mRECIST criteria (measurable lesion with a CT/MRI scan length diameter โ‰ฅ 10 mm and measurable lesion has not received localized treatment such as TACE, radiofrequency, cryotherapy, etc.); 5. ECOG score: 0-1; 6. liver function Child-Pugh class A or B; if combined with obstructive jaundice, total bilirubin โ‰ค50umol/L is required. If higher than 50umol/L, biliary drainage is recommended; 7. Blood routine: absolute neutrophil count โ‰ฅ1.5ร—10\^9/L, Hbโ‰ฅ8.5g/L, PLTโ‰ฅ75ร—10\^9/L; 8. 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; 9. Expected survival time greater than 3 months. Exclusion Criteria: 1. The tumor with extrahepatic metastasis or invaded adjacent organs; 2. Patients received other anti-tumor treatments; 3. Existence of contraindications to TACE; 4. History of allergy to the components or excipients of Lenvatinib or Tislelizumab; 5. 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; 6. Patients with proteinuria suggestive of โ‰ฅ 1 + in routine urine will undergo a 24-hour urine protein test for patients with โ‰ฅ 1 g of 24-hour urine protein; 7. Patients with co-morbidities of other malignant tumors; 8. Patients with co-morbid psychiatric disorders; 9. Patients with pregnant or lactating women; 10. Patients with organ transplant patients; 11. Patients with hypothyroidism or hyperthyroidism.
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What it tests

  • TACE, Lenvatinib, combined with Tislelizumab group
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Where

6 sites
First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, China
Fujian Provincial Hospital
Fuzhou, China
Zhongshan Hospital of Xiamen University
Xiamen, China
First Affiliated Hospital of Xiamen University
Xiamen, China
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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