TACE Combined With ICIs Plus MTT After 125I Irradiation Stent Placement in HCC With Main PVTT.

NCT06669377 | Recruiting

• 1 other identifier: PATENCY2
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; irradiation stent; portal vein tumor thrombosis; immune checkpoint inhibitor; molecular targeted therapy; transcatheter arterial chemoembolization

Outcome Measures

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.

  Up to approximately 2 years

Secondary Outcomes (9)

• Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  up to approximately 2 years

• PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

  up to approximately 2 years

• Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) per RESCIST 1.1

  up to approximately 2 years

• Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) per mRECIST

  up to approximately 2 years

• Disease Control Rate (DCR) per RESCIST 1.1

  up to approximately 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Gaojun Teng, M.D.

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Lu, M.D.

CONTACT

+86-15850654644; lujian43307131@126.com

Gaojun Teng, M.D.

CONTACT

+86-13805171500; gjteng@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: January 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (1)