Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma

NCT ID: NCT06365034

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-01-31

Brief Summary

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To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC).

Detailed Description

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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

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Carcinoma, Hepatocellular

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ≥ 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.

Exclusion Criteria

* 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;
* Known human immunodeficiency virus (HIV) infection;
* Have participated in other therapeutic clinical studies;
* Incomplete clinical data.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Liang, Dr

Role: STUDY_DIRECTOR

the Qianfoshan Hospital

Locations

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the Qianfoshan Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Liang, Dr

Role: CONTACT

0086-18663761275

Facility Contacts

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Jing Liang, Dr

Role: primary

+8618663761275

Other Identifiers

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YKLL-KY-2024(024)

Identifier Type: -

Identifier Source: org_study_id

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