Triple therapy for advanced liver cancer with bile duct tumor thrombus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, single-arm, real-world study aims to evaluate the efficacy and safety of a combination treatment involving Transcatheter arterial chemoembolization (TACE), Lenvatinib, and Tislelizumab for patients diagnosed with Hepatocellular Carcinoma (HCC) that is complicated by bile duct tumor thrombus (BDTT). The study focuses on patients who are not candidates for surgical resection due to the advanced nature of their disease. By assessing the outcomes of this triple therapy approach, the study seeks to provide valuable insights into a treatment strategy that is currently under-researched. The study will include patients who meet specific eligibility criteria, including age, disease stage, and liver function status.

Why it matters

Who can join: the full rules

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 ≥ 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 ≤50umol/L is required. If higher than 50umol/L, biliary drainage is recommended;
7. Blood routine: absolute neutrophil count ≥1.5×10\^9/L, Hb≥8.5g/L, PLT≥75×10\^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 ≥ 1 + in routine urine will undergo a 24-hour urine protein test for patients with ≥ 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.

Where it's running

• Fujian Provincial Hospital
  Fuzhou, Fujian, China Recruiting
• First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Not yet recruiting
• Mengchao Hepatobiliary Hospital of Fujian Medical University
  Fuzhou, Fujian, China Not yet recruiting
• Zhongshan Hospital of Xiamen University
  Xiamen, Fujian, China Not yet recruiting
• First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Not yet recruiting
• Zhangzhou Affiliated Hospital of Fujian Medical University
  Zhangzhou, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Mao-Lin Yan
• Email: yanmaolin74@163.com
• Phone: 0591-88217140

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.