Clinical trial NCT06365034: Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma
Official title: A Single-center, Retrospective Study on the Efficacy and Safety of Conversion Therapy for Patients With Initially Unresectable Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with initial unresectable hepatocellular carcinoma who have undergone conversion therapy.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pathologic response rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: the Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: the Qianfoshan Hospital
name: Jing Liang, Dr
role: STUDY_DIRECTOR
References: