Actively Recruiting
Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)
Led by Fujian Provincial Hospital · Updated on 2024-10-15
20
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Clinical diagnosis of Hepatocellular Carcinoma combined with bile duct tumor thrombus, BCLC Stage B or C, with unresectable HCC decided after multidisciplinary discussion
- No prior tumor-related targeted therapy, immunotherapy, radiotherapy, or chemotherapy
- At least one measurable lesion of 10 mm or larger on CT/MRI scans that has not had local treatments
- ECOG performance status score of 0 to 1
- Liver function classified as Child-Pugh A or B; if obstructive jaundice is present, total bilirubin must be 50 µmol/L or less or biliary drainage is recommended
- Blood counts meeting specified thresholds: neutrophils ≥1.5×10⁹/L, hemoglobin ≥8.5 g/L, platelets ≥75×10⁹/L
- No history of severe heart arrhythmia, heart failure, severe lung disease, severe infection, or kidney failure with creatinine clearance above 40 mL/min
- Expected survival time longer than 3 months
You will not qualify if you...
- Tumor with spread outside the liver or invasion into nearby organs
- Previous anti-tumor treatments
- Contraindications to TACE
- Allergy to Lenvatinib or Tislelizumab or their components
- Active autoimmune disease or autoimmune disease expected to relapse; current immunosuppressive or hormone therapy
- Significant proteinuria (≥1+ in urine test or ≥1 g in 24-hour urine test)
- Other malignant tumors
- Psychiatric disorders
- Pregnant or breastfeeding women
- Organ transplant recipients
- Hypothyroidism or hyperthyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Not Yet Recruiting
2
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350025
Not Yet Recruiting
3
Fujian Provincial Hospital
Fuzhou, Fujian, China
Actively Recruiting
4
Zhongshan Hospital of Xiamen University
Xiamen, Fujian, China, 361005
Not Yet Recruiting
5
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361021
Not Yet Recruiting
6
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China, 363099
Not Yet Recruiting
Research Team
M
Mao-Lin Yan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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