Carcinoma, HepatocellularNCT06365034
Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma
An observational study of Carcinoma, Hepatocellular, run by Qianfoshan Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with initial unresectable hepatocellular carcinoma who have undergone conversion therapy.
Who may be able to join
- ≥ 18 years old, gender is not limited;
- Patients with radiographically or pathologically confirmed, unresectable advanced hepatocellular carcinoma;
- At least one measurable lesion according to the mRECIST criteria as the target lesion;
- No prior immunotherapy, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 antibodies;
- Patients with an ECOG score of 0-2 were included according to the activity status score scale developed by the Eastern Cooperative Oncology Group (ECOG) in the United States;
- Child-Pugh liver function is graded as A or B.
Who cannot join
- Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases;
- Have other malignancies;
- Presence of any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or other patients who are considered by the investigator to have an impact on study treatment;
- Long-term heavy use of corticosteroids or other immunomodulators;
- Serious illness in combination with other systems;
- Received a live or attenuated vaccine within 30 days prior to the first dose, or plans to receive a live or attenuated vaccine during the study, excluding the new crown vaccine;
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- Known human immunodeficiency virus (HIV) infection;
- Have participated in other therapeutic clinical studies;
- Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Qianfoshan Hospital
Jinan, Shandong, 250000
Jing Liang, Dr, +8618663761275, liangjing0531@163.com
About this study
Official title: A Single-center, Retrospective Study on the Efficacy and Safety of Conversion Therapy for Patients With Initially Unresectable Hepatocellular Carcinoma
To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC).
Read the detailed description
To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC). Exon sequencing, 16SrRNA sequencing and immunohistochemistry were used to verify the protein expression, revealing the mechanism of tumor occurrence and development from the genome level, and providing reference for immunotherapy, targeted drug use and curative effect evaluation of tumors.
- Conditions
- Carcinoma, Hepatocellular
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response rate
Proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Liang, Dr, Study director, the Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365034
- Sponsor's protocol ID
- YKLL-KY-2024（024）
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Retrospective Study on the Efficacy and Safety of Conversion Therapy for Patients With Initially Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06365034
- Acronym / sponsor ID
- YKLL-KY-2024（024）
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 15 Apr 2024 (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 efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC).
Detailed description
To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC). Exon sequencing, 16SrRNA sequencing and immunohistochemistry were used to verify the protein expression, revealing the mechanism of tumor occurrence and development from the genome level, and providing reference for immunotherapy, targeted drug use and curative effect evaluation of tumors.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with initial unresectable hepatocellular carcinoma who have undergone conversion therapy.
Key inclusion criteria (6 listed)
- ≥ 18 years old, gender is not limited;
- Patients with radiographically or pathologically confirmed, unresectable advanced hepatocellular carcinoma;
- At least one measurable lesion according to the mRECIST criteria as the target lesion;
- No prior immunotherapy, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 antibodies;
- Patients with an ECOG score of 0-2 were included according to the activity status score scale developed by the Eastern Cooperative Oncology Group (ECOG) in the United States;
Key exclusion criteria (9 listed)
- Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases;
- Have other malignancies;
- Presence of any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or other patients who are considered by the investigator to have an impact on study treatment;
- Long-term heavy use of corticosteroids or other immunomodulators;
- Serious illness in combination with other systems;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathologic response rate
Time frame: 2 years
Proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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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.
Jing Liang, Dr study director
the Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Qianfoshan Hospital at 1 site 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: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Liang, Dr (0086-18663761275, liangjing0531@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response rate (time frame: 2 years). 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 15 Apr 2024.