PIN in Combination With Anti-PD1 in Previously Treated Primary Hepatocellular Carcinoma
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
In this single-center,open-label, phase I study, the safety and efficacy of PIN in combination with programmed cell death protein antibody (anti-PD1) therapeutic regimen will be evaluated in patients with refractory primary advanced hepatocellular carcinoma(HCC) . A total of 25 to 30 patients are planned to be enrolled and receive PIN plus anti-PD1 combined treatment. It aims to: 1).assess the safety and antitumor effects of the above combined treatment regimen. 2).detect the dynamic changes and molecular characteristics of PIN-induced CD8+ T cells with special phenotype in peripheral blood (PB) and transformation of tumor microenvironment (TME) after the treatment with PIN. 3).evaluate the immunological or clinical predictive biomarkers for toxicity and efficacy.
Sponsor: Chinese PLA General Hospital
You may qualify if…
- ✓ 1. Age 18-75 (inclusive).
- ✓ 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and Estimated life expectancy of more than 3 months.
- ✓ 3. Histopathological /cytological or diagnosed clinically confirmed locally advanced or metastatic HCC having undergone treatments recommended by the "Primary Liver CancerDiagnosis and Treatment Guidelines (2024 Edition)" ,which is refractory/relapsed after and/or intolerant of standard therapies (including targeted therapy and immunotherapy) or for which no subsequent standard therapy exists.
- ✓ 4. At least one measurable lesion at baseline according to investigators Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).
- ✓ 5. Patients with injectable lesions (those suitable for direct injection or injection with the assistance of medical imaging), defined as follows: at least one injectable lesion in the skin, mucous membrane, subcutaneous tissue, lymph node or visceral organ with a longest diameter ≥10 mm.
- ✓ 6. Subjects are willing to accept tumor rebiopsy in the process of this study.
- ✓ 7. Barcelona Clinic Liver Cancer (BCLC) stage ≤C.
- ✓ 8. Adequate organ function as defined by the following criteria:
You may not qualify if…
- ✕ 1. Subjects are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- ✕ 2. Active central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to enrollment that are clinically stable and do not require intervention), or prior history of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 drug-related Central Nervous System (CNS) toxicity.
- ✕ 3. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management.
- ✕ 4. Any serious underlying medical (eg, pulmonary, renal, hepatic,gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements.
- ✕ 5. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
- ✕ 6. Received cytotoxic chemicals, monoclonal antibodies, immunotherapy or other intervene within 4 weeks or 5 half-lives before enrollment.
- ✕ 7. Received radiotherapy within 3 months before enrollment.
- ✕ 8. Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy.
Source: ClinicalTrials.gov · NCT07018518 · last updated 2025-06-22