Clinical trial · Observational
Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)
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
NCT06602011CI-TRIAL-00081584recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE, Lenvatinib, combined with Tislelizumab group | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Triple Therapy
- interventionNames
- Combination Product: TACE, Lenvatinib, combined with Tislelizumab group
Primary outcomes (1)
- measure
- Objective response rate, ORR
- timeFrame
- Four weeks after the initiation of medication until the day before surgery
- description
- The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to mRECIST.
Secondary outcomes (5)
- measure
- Overall survival, OS
- timeFrame
- From date of enrollment until the date of death from any cause, assessed up to 60 months
- description
- The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.