TACE Combined With ICIs Plus MTT After 125I Irradiation Stent Placement in HCC With Main PVTT.
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhongda Hospital
About this trial
Hepatocellular carcinoma (HCC) patients with Vp4 \[main trunk\] portal vein tumor thrombosis (PVTT) face a significantly poor prognosis, and current treatment options provide limited benefits. We aimed to assess the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) after irradiation stent placement (ISP) as first line treatment for HCC patients with Vp4 PVTT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥18 years old; (2) diagnosis of HCC is confirmed through histological or cytological analysis, as well as clinical features; (3) histologically confirmed or imaging-diagnosed PVTT extending to the main portal vein (Vp4); (4) including at least one measurable intrahepatic lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; (5) Eastern Cooperative Oncology Group (ECOG) performance status of ≤2; (6) patients received first-line treatment with either ICIs-MTT or an ISP-containing quadruple combination within eight weeks (In the ICIs-MTT group, MTT was administered alongside ICIs. In the ISP-containing quadruple, TIT and ICIs-MTT were given after stent placement and portal vein recanalization, either simultaneously or within eight weeks before or after the ICIs-MTT therapy).
Disqualifiers
patients with extrahepatic metastases; (2) a history of or concurrent malignancies; (3) patients underwent prior systemic treatments or locoregional therapies, including surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection, and cryoablation, within three months before the initiation of ISP.; (4) Child-Pugh grade C liver function, a Child-Pugh score of 3 for ascites, or the presence of overt hepatic encephalopathy; (5) incomplete outcome data or missing essential baseline factors for analysis.
Trial population
Patients with HCC and Vp4 PVTT who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies after 125I irradiation stent placement under real-world practice conditions
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
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 Response Evaluation Criteria in Solid Tumors Version 1.1 (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 Modified Response Evaluation Criteria in Solid Tumors (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) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) 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
Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) per mRECIST
The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Time frame
up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov