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

NCT05292443 | Withdrawn

• 1 other identifier: HisPower-Lib 002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

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

Keywords

Next Generation Sequencing (NGS); Liquid biopsy; Immune Checkpoint Inhibitor; Whole Transcriptome Sequencing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ORR: Objective Response Rate

  24 months

• OS: Overall Survival

  24 months

• TTD: Time to Treatment Discontinuation

  24 months

Interventions

Observation OTHER

observe the association of ctDNA with efficacy of treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary liver cancer including hepatocellular carcinoma, intrahepatic cholangiocarcinoma and combined hepatocellular-cholangiocarcinoma

You may qualify if:

• Primary liver cancer diagnosed according to the clinical diagnostic criteria, or histopathological or cytological examination;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Geneplus-Beijing Co. Ltd.: lead
• Eastern Hepatobiliary Surgery Hospital: collaborator

Study Sites (5)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Beijing hospital

Beijing, Beijing Municipality, 100730, China

Location

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

Chongqing, Chongqing Municipality, 401147, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University

Wuhan, Hubei, 430030, China

Location

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200438, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood (including plasma, white cells), tissue

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

Interventions

Observation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Feng Shen, MD PhD

  Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: December 20, 2021
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CN (5)