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IIT study on the efficacy and safety of minimally invasive ablation combined with AYK103 injection in the treatment of liver cancer

IIT study on the efficacy and safety of minimally invasive ablation combined with AYK103 injection in the treatment of liver cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073451
Enrollment
Unknown
Registered
2023-07-11
Start date
2023-07-05
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Liver Cancer

Interventions

Sponsors

Huhhot Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily act as a participant, and sign the informed consent form before starting any procedure; 2) Male or female patients aged 18~75 (including boundary values); 3) Clinical judgment of patients with intermediate and advanced tumors 3) Eastern Cancer Cooperative (ECOG) performance status score of =2; 4) Estimated survival time = 3 months; 5) Patients with indications for minimally invasive surgery and normal coagulation function. 6) Be able to communicate well with the investigator, and understand and comply with the requirements of this study.

Exclusion criteria

Exclusion criteria: With "Expert consensus on the clinical standardization of image-guided thermal ablation therapy technology for liver tumors", see Reference 21. 2) Patients with allergies or hypersensitivity to similar products or excipients; 3) Those who use other investigational drugs or participate in clinical trials of other drugs within 28 days before the first dose; 4) Have received anti-tumor therapy, including radiotherapy (except palliative ), chemotherapy, biological therapy and immunotherapy within 28 days before the first dose. 5) Those who have received systemic corticosteroids or other immunosuppressive drugs within 28 days before the first dose; 6) High-risk patients with brain metastasis, spinal cord compression, carcinogenic meningitis, etc., or other evidence that the patient's brain and spinal cord metastasis has not been controlled, and the investigator judges that it is not suitable for enrollment; 7) Clinically obvious and/or rapidly accumulating moderate amount of ascites, pericardial and/or pleural fluid with moderate or higher effusion; 8) Have a history of severe cardiovascular and cerebrovascular diseases, refer to the exclusion criteria of minimally invasive ablation. 9) The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE v5.0 grade evaluation = grade 1 (except for toxicity judged by researchers to be no safety risk such as hair loss); 10) Patients who are uncontrollable or have serious illness, including but not limited to persistent or active infections requiring antibiotic therapy; 11) Previous history of immunodeficiency, or history of organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation; 12) History of exfoliative skin requiring systemic treatment (such as eczema or atopic dermatitis, etc.); 13) Human immunodeficiency virus (HIV) antibody positive person; Patients with active hepatitis B (HBV)/hepatitis C (HCV) infection; 14) Those who have had their spleen removed; Immune hepatitis; Patients with cirrhosis. 15) Patients judged by the investigator to be unsuitable for participation in the study, such as adjacent airways or tumors located at high risk of adverse events or inappropriate intratumoral injection locations, or poor compliance with patients and families.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;Cellular immunity;

Countries

China

Contacts

Public ContactChunwang Yuan

Huhhot Second Hospital

18612778605@163.com+86 186 1277 8605

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026