RecruitingPhase 3NCT03949231

Infusion of PD1/PDL1/CTLA4 Inhibitors Via Hepatic Arterial for Immunotherapy of Hepatocellular Carcinoma

A Phase II/III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1/CTLA4 Inhibitor or Their Combinations Via Hepatic Arterial Infusion Versus Vein for Immunotherapy of Advanced Liver Cancer

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

200 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Liver Cancer

Summary

This trial was designed to investigate the survival outcomes, response rates, and safety of patients with Barcelona-Clinical Hepatocellular Carcinoma (BCLC)-C-stage liver cancer by hepatic artery versus vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria10

Cytohistological confirmation is required for diagnosis of HCC.、
Signed informed consent before recruiting
Age between 18 to 80 years with estimated survival over 3 months.
Child-Pugh class A or B/Child score \> 7; ECOG score \< 2
Tolerable coagulation function or reversible coagulation disorders
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
At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
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.
Birth control.
Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Exclusion Criteria13

Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
Patients accompanied with other tumors or past medical history of malignancy;
Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
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).
Patients have the past history of liver cancer treatment, such as transplantation, resection, radiotherapy, chemotherapy and so on;
Allergic to adriamycin chemotherapy drugs，contrast agent and lipiodol;
Any agents which could affect the absorption or pharmacokinetics of the study drugs
Subjects unable to suffer the discomfort of the HAI procedure

Interventions

DRUGPD1/PDL1 inhibitor

Infusion of PD1/PDL1 inhibitor through peripheral vein or hepatic artery.

Locations(1)

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT03949231

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