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
This trial does not accept healthy volunteersQualifiers
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 population
Intermediate-advanced Hepatocellular Carcinoma With Bile Duct Tumor Thrombus
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TACE, Lenvatinib, combined with Tislelizumab group
Combination productTACE, Lenvatinib \[8mg(\<60kg)/12mg(\>60kg) orally daily\] combination with Tislelizumab (200mg administered intravenous injection on Day 1 of each 21-day cycle). After the triple therapy, surgical resection is an option if assessed by the investigator to be feasible, or continued until disease progression or intolerable if not.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Triple Therapy1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate, ORR
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to mRECIST.
Time frame
Four weeks after the initiation of medication until the day before surgerySecondary outcomes
1
Overall survival, OS
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Time frame
From date of enrollment until the date of death from any cause, assessed up to 60 months2
Progression free survival, PFS
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months3
The Disease control rate, DCR
The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to mRECIST.
Time frame
Four weeks after the initiation of medication until the day before surgery4
Conversion resection rate, CRR
The Conversion resection rate (CRR) was defined as the patient who reach the resectable criterion after treatment and accepted operation.
Time frame
Four weeks after the initiation of medication until the day before surgerySponsors and contacts
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Source ClinicalTrials.gov