Infusion of immune inhibitors for liver cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the survival outcomes, response rates, and safety of patients with advanced liver cancer by comparing the infusion of PD1/PDL1/CTLA4 inhibitors through the hepatic artery versus the vein. Given the high mortality rate of liver cancer, particularly in China, this study aims to explore a more effective treatment method that could enhance local drug concentration at the tumor site while minimizing systemic side effects. The trial includes patients diagnosed with unresectable hepatocellular carcinoma who have limited treatment options available. By utilizing the hepatic arterial infusion method, the study seeks to improve the efficacy of existing immunotherapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Cytohistological confirmation is required for diagnosis of HCC.、
2. Signed informed consent before recruiting
3. Age between 18 to 80 years with estimated survival over 3 months.
4. Child-Pugh class A or B/Child score \> 7; ECOG score \< 2
5. Tolerable coagulation function or reversible coagulation disorders
6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR \< 2.3 or PT \< 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin \> 28 g/L；Total bilirubin \< 51 μmol/L
7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
8. Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer \[BCLC\] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
9. Birth control.
10. 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.

   Any contraindications for hepatic arterial infusion procedure:

   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. Patients have the past history of liver cancer treatment, such as transplantation, resection, radiotherapy, chemotherapy and so on;
8. Allergic to adriamycin chemotherapy drugs，contrast agent and lipiodol;
9. Any agents which could affect the absorption or pharmacokinetics of the study drugs
10. Subjects unable to suffer the discomfort of the HAI procedure

Where it's running

• The Second Affiliated Hospital of Guangzhou Medical University
  Guanzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Hui Lian, MD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Hui Lian, MD
• Email: lian-hui-2008@163.com
• Phone: 02034153532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.