Triple therapy for advanced liver cancer with bile duct tumor thrombus

Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Tislelizumab for Intermediate-advanced Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: A Multicenter, Single-arm, Real-world Study

This study is testing a new combination treatment for people with advanced liver cancer that has spread to the bile ducts to see if it can help them when surgery isn't an option.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Provincial Hospital (Academic / other)
• Drugs / interventions: Tislelizumab, Lenvatinib, chemotherapy, immunotherapy
• Locations: 6 sites (Fuzhou, Fujian and 5 other locations)
• Trial ID: NCT06602011 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with unresectable Hepatocellular Carcinoma combined with bile duct tumor thrombus.

Not a fit: Patients who have previously received tumor-related targeted therapies, immunotherapy, radiotherapy, or chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with unresectable HCC and BDTT, potentially offering a new therapeutic option.

How similar studies have performed: While there is limited literature on this specific combination therapy for HCC with BDTT, similar approaches have shown promise in treating advanced HCC.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian and 5 other locations

• 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)
• Fujian Provincial Hospital — Fuzhou, Fujian, China (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

Conditions Hepatocellular Carcinoma; Hepatocellular carcinoma; bile duct tumor thrombus; TACE; Lenvatinib; Tislelizumab