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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05292443
• Other study ID #: HisPower-Lib 002
• Status: Withdrawn
• Start date: December 20, 2021
• Est. completion date: March 17, 2023

Study information

• Verified date: February 2024
• Source: Geneplus-Beijing Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hepatocellular Carcinoma
• Intrahepatic Cholangiocarcinoma
• Liver Neoplasms
• Primary Liver Cancer

Intervention

Other:
• Observation
observe the association of ctDNA with efficacy of treatment

Locations

Country	Name	City	State
China	Beijing hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	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	Tongji Hospital affiliated to Tongji Medical College of Huazhong University	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Geneplus-Beijing Co. Ltd.	Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS: Progression-free survival	The time length from the date of randomization to any of the following events: disease progression or death from any cause.	24 months
Secondary	ORR: Objective Response Rate	The proportion of patients with complete response or partial response.	24 months
Secondary	OS: Overall Survival	The time length from the date of randomization to the date of death.	24 months
Secondary	TTD: Time to Treatment Discontinuation	The time length from the date of randomization to the date of treatment discontinuation.	24 months