Primary Liver CancerNCT05292443
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer
An observational study of Primary Liver Cancer and Hepatocellular Carcinoma, run by Geneplus-Beijing Co. Ltd. at 5 sites in China.
Trial summary
To evaluate the predictive value of ctDNA in response, relapse for liver cancer patients treated with immune checkpoint inhibitors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Liver Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma
- What is being tested?
- Observation
- How many people
- 0 participants
- Where
- 5 sitesChina
- Study dates
- 20 Dec 2021to 17 Mar 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary liver cancer including hepatocellular carcinoma, intrahepatic cholangiocarcinoma and combined hepatocellular-cholangiocarcinoma
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Beijing hospital
Beijing, Beijing Municipality, 100730
Institute of Hepatopancreatobiliary Surgery, Chongqing General Hospital, University of Chinese Academy of Sciences (UCAS)
Chongqing, Chongqing Municipality, 401147
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200438
Tongji Hospital affiliated to Tongji Medical College of Huazhong University
Wuhan, Hubei, 430030
About this study
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.
- Conditions
- Primary Liver Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Combined Hepatocellular-cholangiocarcinoma
- Being tested
- Observation
- Keywords
- Next Generation Sequencing (NGS), Liquid biopsy, Immune Checkpoint Inhibitor, Whole Transcriptome Sequencing
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
observe the association of ctDNA with efficacy of treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (3)
ORR: Objective Response Rate
The proportion of patients with complete response or partial response.
Measured: 24 months
OS: Overall Survival
The time length from the date of randomization to the date of death.
Measured: 24 months
TTD: Time to Treatment Discontinuation
The time length from the date of randomization to the date of treatment discontinuation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start20 Dec 2021
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Why it stopped: No participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Sponsor
- Investigators
- Feng Shen, MD PhD, Principal investigator, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292443
- Sponsor's protocol ID
- HisPower-Lib 002
- Status last verified
- Feb 2024
- First submitted
- 14 Mar 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT05292443
- Acronym / sponsor ID
- HisPower-Lib 002
- Conditions
- Primary Liver Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Combined Hepatocellular-cholangiocarcinoma
- Keywords
- Next Generation Sequencing (NGS), Liquid biopsy, Immune Checkpoint Inhibitor, Whole Transcriptome Sequencing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Geneplus-Beijing Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary liver cancer including hepatocellular carcinoma, intrahepatic cholangiocarcinoma and combined hepatocellular-cholangiocarcinoma
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationobserve the association of ctDNA with efficacy of treatment | Other | – |
Primary outcome
PFS: Progression-free survival
Time frame: 24 months
The time length from the date of randomization to any of the following events: disease progression or death from any cause.
3 secondary outcomes
ORR: Objective Response Rate
Time frame: 24 months
OS: Overall Survival
Time frame: 24 months
TTD: Time to Treatment Discontinuation
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Shen, MD PhD principal investigator
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Liver Cancer and Hepatocellular Carcinoma, run by Geneplus-Beijing Co. Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS: Progression-free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.