Prognosis Stratification for Advanced HCC Receiving TACE with PD-1/PD-L1 Inhibitors and Molecular Target Therapies

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT06607120
• Lead Sponsor: Zhongda Hospital

Brief Summary

The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.

Detailed Description

In patients with advanced-stage hepatocellular carcinoma (HCC), previous studies showed that transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies exhibited better efficacy (PFS and OS) as compared to the ICIs and molecular target therapies. However, there is a lack of effective tools to select those who will benefit the most from that combination therapy. The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage HCC who receive TACE and immune checkpoint ICIs plus molecular target therapies (including, VEGF-TKI/ bevacizumab). This real-world study may provide further information on treatment selection for clinical practice and trials.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
7. Has repeated measurable intrahepatic lesions;

Exclusion Criteria

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
2. Unable to meet criteria of combination timeframe described above;
3. Child-Pugh C or PS>2 or Severe hepatic encephalopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	up to approximately 2 years	The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	up to approximately 2 years	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.
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)	up to approximately 2 years	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.
Objective response rate(ORR) per RESCIST 1.1	up to approximately 2 years	The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
ORR per mRECIST	up to approximately 2 years	The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Duration of Response (DOR) per RESCIST 1.1	up to approximately 2 years	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.
DOR per mRECIST	up to approximately 2 years	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 mRECIST) or death due to any cause, whichever occurs first.
Disease Control Rate (DCR) per RESCIST 1.1	up to approximately 2 years	DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.
DCR per mRECIST	up to approximately 2 years	DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0	up to approximately 2 years	The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China