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

Sponsor

Geneplus-Beijing Co. Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05292443

Collaborator

Eastern Hepatobiliary Surgery Hospital (Other)

300

Enrollment

Locations

27.4

Anticipated Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Liver Cancer Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Combined Hepatocellular-cholangiocarcinoma	Other: Observation

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 20, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital Capital Medical University	Beijing	Beijing	China	100053
2	Beijing hospital	Beijing	Beijing	China	100730
3	Institute of Hepatopancreatobiliary Surgery, Chongqing General Hospital, University of Chinese Academy of Sciences (UCAS)	Chongqing	Chongqing	China	401147
4	Tongji Hospital affiliated to Tongji Medical College of Huazhong University	Wuhan	Hubei	China	430030
5	Eastern Hepatobiliary Surgery Hospital, Second Military Medical University	Shanghai	Shanghai	China	200438