Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Provincial Hospital
About this trial
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
Qualifiers
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.);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- TACE, Lenvatinib, combined with Tislelizumab group
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov