Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with liver cancer, specifically a type called hepatocellular carcinoma (HCC). The aim is to see how safe this treatment is, how well it works, and how it affects survival rates. The treatment involves injecting a combination of two immune-boosting drugs directly into the tumor. This is done with the help of a special imaging technique to guide the injection. The trial is currently looking for participants who are between the ages of 65 and 74 and are suitable candidates for surgery.

To be eligible for the trial, patients must have a confirmed diagnosis of HCC that has not been treated before. They should also be in good overall health, meaning they can perform daily activities without major issues. Participants will need to provide consent to join the study and adhere to scheduled visits and treatments. It's important to note that some individuals, such as those with certain health conditions or those who are pregnant, may not qualify for the trial. If you or a loved one are interested, this trial could offer a new option for treating liver cancer while contributing to valuable research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically confirmed previously untreated hepatocellular carcinoma (HCC). If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected HCC are eligible, but pathology must be confirmed prior to initiating treatment on study.
• • 2. The patient must be a suitable candidate for surgery, in the opinion of the treating physician.
• • 3. Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
• • 5. Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L; Hemoglobin \>= 8.0 g/dL; Platelets \>= 100 x 10\^9/L; Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin \< 3.0 mg/dL); Creatinine =\< 1.5 x ULN or calculated creatinine clearance \>= 50 mL/min using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance \>= 50 mL/min.
• • 6. Birth control.
• • 7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
• Exclusion Criteria:
• • 1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
• • 2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
• • 3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
• • 4. Patients accompanied with other tumors or past medical history of malignancy;
• • 5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
• • 6. Patients have poor compliance. A.Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 50%).
• • B.Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\> 160/100 mm/Hg).
• • 7. Allergic to contrast agent;
• • 8. Any agents which could affect the absorption or pharmacokinetics of the study drugs
• • 9. Other conditions that investigator decides not suitable for the trial.