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

Carcinoma, Hepatocellular Clinical Trial

Official title:

A Single-center, Retrospective Study on the Efficacy and Safety of Conversion Therapy for Patients With Initially Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365034
• Other study ID #: YKLL-KY-2024(024)
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: Qianfoshan Hospital
• Contact: Jing Liang, Dr
• Phone: 0086-18663761275
• Email: liangjing0531[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: January 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Locations

Country	Name	City	State
China	the Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic response rate	Proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit	2 years