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

NCT06607120 | Recruiting

• 1 other identifier: CHANCE2420
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; transarterial chemoembolization; immune checkpoint inhibitors; molecular target therapies; advanced stage; prognosis model

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) per RESCIST 1.1

  up to approximately 2 years

• ORR per mRECIST

  up to approximately 2 years

• Duration of Response (DOR) 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 advanced HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 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

• Gao- Teng, M.D

  Zhongda hospital, Southeast university, Nanjing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao-Jun Teng, M.D

CONTACT

+86-02583272121; gjteng@vip.sina.com

Hai-Dong Zhu, M.D

CONTACT

+86-02583272121; zhuhaidong9509@163.com

Study Design

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

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 23, 2024
• Study Start: June 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-08

Locations

CN (1)