TACE in Combination With Tislelizumab and Lenvatinib for Advanced HCC (CHANCE2602)
ConditionHepatocellular Carcinoma (HCC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorZhongda Hospital
About this trial
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with Tislelizumab and Lenvatinib in patients with advanced-stage hepatocellular carcinoma (HCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients who meet the clinical diagnostic criteria for primary liver cancer;
Age ≥18 years at the time of HCC diagnosis;
Barcelona Clinic Liver Cancer (BCLC) stage C;
No prior systemic therapy for HCC (including chemotherapy, molecular targeted therapy, or immunotherapy);
Disqualifiers
Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma histological types;
Complete obstruction of the main portal vein with insufficient collateral compensation;
Uncontrollable ascites or hepatic encephalopathy;
Incomplete clinical data or missing essential information;
Trial population
Patients with advanced HCC who received Tislelizumab and Lenvatinib with/without TACE under real-world practice conditions.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
596 Participants
are grouped into 2 trial groupsGroup A: Study group
Group B: Control group
Trial outcomes
Primary outcomes
1
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Time frame
up to approximately 2 yearsSecondary outcomes
1
Progression free survival(PFS) per RECIST 1.1
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.
Time frame
up to approximately 2 years2
PFS per mRECIST
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Time frame
up to approximately 2 years3
Objective response rate(ORR) per RESCIST 1.1
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Time frame
up to approximately 2 years4
Duration of Response (DOR) per RESCIST 1.1
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first.
Time frame
up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: