NCT06602011 Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)
| NCT ID | NCT06602011 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujian Provincial Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-09-30 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06602011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06602011 currently recruiting?
Yes, NCT06602011 is actively recruiting participants. Contact the research team at yanmaolin74@163.com for enrollment information.
Where is the NCT06602011 trial being conducted?
This trial is being conducted at Fuzhou, China, Fuzhou, China, Fuzhou, China, Xiamen, China and 2 additional locations.
Who is sponsoring the NCT06602011 clinical trial?
NCT06602011 is sponsored by Fujian Provincial Hospital. The trial plans to enroll 20 participants.
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