Status:
RECRUITING
Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)
Lead Sponsor:
Fujian Provincial Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
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 p...
Detailed Description
Surgical resection is considered to be the treatment of choice for Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT), but a significant proportion of patients with HCC combi...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years old;
- 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);
- Patients who had not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;
- 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.);
- ECOG score: 0-1;
- 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;
- Blood routine: absolute neutrophil count ≥1.5×10\^9/L, Hb≥8.5g/L, PLT≥75×10\^9/L;
- 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;
- Expected survival time greater than 3 months.
Exclusion
- The tumor with extrahepatic metastasis or invaded adjacent organs;
- Patients received other anti-tumor treatments;
- Existence of contraindications to TACE;
- History of allergy to the components or excipients of Lenvatinib or Tislelizumab;
- 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;
- 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;
- Patients with co-morbidities of other malignant tumors;
- Patients with co-morbid psychiatric disorders;
- Patients with pregnant or lactating women;
- Patients with organ transplant patients;
- Patients with hypothyroidism or hyperthyroidism.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06602011
Start Date
September 30 2024
End Date
October 1 2028
Last Update
October 15 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
2
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350025
3
Fujian Provincial Hospital
Fuzhou, Fujian, China
4
Zhongshan Hospital of Xiamen University
Xiamen, Fujian, China, 361005