Evaluating conversion therapy for patients with advanced liver cancer

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

This study is testing a new treatment approach for patients with advanced liver cancer to see if it can make their tumors easier to treat and improve their outcomes.

Quick facts

• Study type: Observational
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06365034 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of conversion therapy in patients diagnosed with initially unresectable hepatocellular carcinoma (uHCC). It employs advanced techniques such as exon sequencing, 16SrRNA sequencing, and immunohistochemistry to analyze protein expression and understand the tumor's genomic mechanisms. The findings will provide insights into potential immunotherapy and targeted drug applications, as well as evaluate the therapeutic effects on tumors.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed unresectable hepatocellular carcinoma and at least one measurable lesion.

Not a fit: Patients with a history of immunodeficiency, other malignancies, or active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer new treatment options for patients with advanced liver cancer that is currently deemed unresectable.

How similar studies have performed: While there is ongoing research in this area, the specific approach of this study may be novel and untested.

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.

Where this trial is running

Jinan, Shandong

• the Qianfoshan Hospital — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Jing Liang, Dr

Conditions: Carcinoma, Hepatocellular