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RecruitingNCT06365034Updated Apr 15, 2024

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

An observational study in Carcinoma, Hepatocellular, sponsored by Qianfoshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Qianfoshan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
92
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Carcinoma, Hepatocellular
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 92 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
92 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

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

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • the Qianfoshan Hospital
    Jinan, Shandong 250000, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06365034
Lead sponsor
Qianfoshan Hospital
Responsible party
Sponsor
First posted
Apr 15, 2024
Start date
Mar 1, 2024
Primary completion
Oct 1, 2024 (estimated)
Completion
Jan 31, 2025 (estimated)
Last update
Apr 15, 2024

Study contacts

Jing Liang, Dr
Contact
liangjing0531@163.com
0086-18663761275
Jing Liang, Dr
study director · the Qianfoshan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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