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

Withdrawn

• Conditions: Primary Liver Cancer; Hepatocellular Carcinoma; Intrahepatic Cholangiocarcinoma; Combined Hepatocellular-cholangiocarcinoma

• Registration Number: NCT05292443
• Lead Sponsor: Geneplus-Beijing Co. Ltd.

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.

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Primary Completion: 2023-03-17
• Study Completion: 2023-03-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS: Progression-free survival	24 months	The time length from the date of randomization to any of the following events: disease progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
TTD: Time to Treatment Discontinuation	24 months	The time length from the date of randomization to the date of treatment discontinuation.
OS: Overall Survival	24 months	The time length from the date of randomization to the date of death.
ORR: Objective Response Rate	24 months	The proportion of patients with complete response or partial response.

Trial Locations

Locations (5)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University; 🇨🇳 Wuhan, Hubei, China

Beijing hospital; 🇨🇳 Beijing, Beijing, China

Institute of Hepatopancreatobiliary Surgery, Chongqing General Hospital, University of Chinese Academy of Sciences (UCAS); 🇨🇳 Chongqing, Chongqing, China

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China