Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer

NCT ID: NCT05292443

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2023-03-17

Brief Summary

To evaluate the predictive value of ctDNA in response, relapse for liver cancer patients treated with immune checkpoint inhibitors

Detailed Description

In the study, 300 advanced primery liver cancer patients who received immune checkpoint inhibitors at first-line setting (N=200) or second-line setting (N=100) will be recruited. By analyzing the ctDNA and peripheral blood mononuclear cell (PBMC) collected before and after the first cycle of ICI treatment, the dynamic changes of bTMB, ctDNA and the composition of immune cells will be detected. Combined with the tumor markers AFP, DCP and CA19-9, a noninvasive multiparameter model will be developed.

Conditions

Primary Liver Cancer; Hepatocellular Carcinoma; Intrahepatic Cholangiocarcinoma; Combined Hepatocellular-cholangiocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Observation

observe the association of ctDNA with efficacy of treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Primary liver cancer diagnosed according to the clinical diagnostic criteria, or histopathological or cytological examination;
• 18-80 years old, no limit on gender;
• ECOG performance status of 0-2, with expected survival time of more than 12 weeks;
• According to RECIST V1.1, there must be at least one measurable lesion;
• Patients who are suitable for ICIs treatment and willing to comply with required protocols and give permission to use the data for clinical research and products development;
• Patients who join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

Exclusion Criteria

• Patients with other primary cancers;
• Patients with a severe parenchymal disease and unable to accept ICIs treatment;
• Patients with a psychiatric disorder and unable to comply with this study;
• Patients with symptomatic brain metastasis, anticipated complications or cognitive disorders that are associated with brain metastasis;
• Adverse events related to prior anti-tumor treatment (except for hair loss of any grade) did not return to grade 1 or better;
• History of cells or organ transplantation;
• History of hypersensitivity to the drug administered in this study or contrast media for CT and MRI;
• Patients who accepted hepatic local therapy (including ablation therapy, percutaneous injection of ethanol or acetic acid (PEI/PAI), high-intensity focused ultrasound (HIFU), transarterial chemoembolization (TACE)) within 14 days prior to initiation of the study;
• Other reasons that the researchers think not suitable for ICIs treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: collaborator

Geneplus-Beijing Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feng Shen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Beijing hospital

Beijing, Beijing Municipality, China

Institute of Hepatopancreatobiliary Surgery, Chongqing General Hospital, University of Chinese Academy of Sciences (UCAS)

Chongqing, Chongqing Municipality, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University

Wuhan, Hubei, China

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

HisPower-Lib 002

Identifier Type: -

Identifier Source: org_study_id