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

Recruiting

• Conditions: Carcinoma, Hepatocellular

• Registration Number: NCT06365034
• Lead Sponsor: Qianfoshan Hospital

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.

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-10-01
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic response rate	2 years	Proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit

Trial Locations

Locations (1)

the Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China