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WithdrawnNCT05292443Updated Feb 23, 2024

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

An observational study in Primary Liver Cancer, Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, sponsored by Geneplus-Beijing Co. Ltd.. Withdrawn at 5 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Geneplus-Beijing Co. Ltd. · Observational

Why this study was withdrawn
No participants were enrolled
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • Next Generation Sequencing (NGS)
  • Liquid biopsy
  • Immune Checkpoint Inhibitor
  • Whole Transcriptome Sequencing
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

Browse Liver Neoplasms studies →

Lead sponsor

Geneplus-Beijing Co. Ltd. is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • OtherObservation

    observe the association of ctDNA with efficacy of treatment

06

What researchers measure

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.

    Time frame: 24 months

Secondary outcomes

  1. ORR: Objective Response Rate

    The proportion of patients with complete response or partial response.

    Time frame: 24 months

  2. OS: Overall Survival

    The time length from the date of randomization to the date of death.

    Time frame: 24 months

  3. TTD: Time to Treatment Discontinuation

    The time length from the date of randomization to the date of treatment discontinuation.

    Time frame: 24 months

07

Study locations

5 sites
  • Xuanwu Hospital Capital Medical University
    Beijing, Beijing 100053, China
  • Beijing hospital
    Beijing, Beijing 100730, China
  • Institute of Hepatopancreatobiliary Surgery, Chongqing General Hospital, University of Chinese Academy of Sciences (UCAS)
    Chongqing, Chongqing 401147, China
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University
    Wuhan, Hubei 430030, China
  • Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
    Shanghai, Shanghai 200438, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05292443
Lead sponsor
Geneplus-Beijing Co. Ltd.
Collaborators
Eastern Hepatobiliary Surgery Hospital
Responsible party
Sponsor
First posted
Mar 23, 2022
Start date
Dec 20, 2021
Primary completion
Mar 17, 2023
Completion
Mar 17, 2023
Last update
Feb 23, 2024

Study contacts

Feng Shen, MD PhD
principal investigator · Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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