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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06365034
Enrollment
92
Registered
2024-04-15
Start date
2024-03-01
Completion date
2025-01-31
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

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.

Interventions

None listed

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pathologic response rate2 yearsProportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit

Countries

China

Contacts

Primary ContactJing Liang, Dr
liangjing0531@163.com0086-18663761275

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026