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

NCT06365034 | Recruiting

• 1 other identifier: YKLL-KY-2024（024）
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with initial unresectable hepatocellular carcinoma who have undergone conversion therapy.

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

the Qianfoshan Hospital

Jinan, Shandong, 250000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue and adjacent tissues of the patient

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jing Liang, Dr

  the Qianfoshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Jing Liang, Dr

CONTACT

0086-18663761275; liangjing0531@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: January 31, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (1)