Clinical trial NCT05292443: Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer
Official title: Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Primary Liver Cancer
Hepatocellular Carcinoma
Intrahepatic Cholangiocarcinoma
Combined Hepatocellular-cholangiocarcinoma
Keywords: Next Generation Sequencing (NGS)
Liquid biopsy
Immune Checkpoint Inhibitor
Whole Transcriptome Sequencing
Lead sponsor: Geneplus-Beijing Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Eastern Hepatobiliary Surgery Hospital
First posted: 2022-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary liver cancer including hepatocellular carcinoma, intrahepatic cholangiocarcinoma and combined hepatocellular-cholangiocarcinoma

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.

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

Primary outcomes:
measure: PFS: Progression-free survival
timeFrame: 24 months
Secondary outcomes:
measure: ORR: Objective Response Rate
timeFrame: 24 months
measure: OS: Overall Survival
timeFrame: 24 months
measure: TTD: Time to Treatment Discontinuation
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing hospital
state: Beijing
city: Chongqing
country: China
facility: Institute of Hepatopancreatobiliary Surgery, Chongqing General Hospital, University of Chinese Academy of Sciences (UCAS)
state: Chongqing
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University
state: Hubei
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: Feng Shen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: