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

NCT03949231 | Recruiting Phase 3

• 1 other identifier: ZZIAICI-008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cancer

Keywords

Liver Cancer; PD1 antibody; Artery infusion; PDL1 antibody; CTLA4 antibody

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.

  2 years

Secondary Outcomes (2)

• Progression-free survival

  2 years

• Adverse event rate

  2 years

Study Arms (2)

PD1/PDL1/CTLA4 inhibitor or their combinations hepatic artery infusion

EXPERIMENTAL

Interventional technique to place microcatheter in hepatic artery to infuse PD1/PDL1/CTLA4 inhibitor or their combinations in 30 minutes.

Drug: PD1/PDL1 inhibitor

PD1/PDL1/CTLA4 inhibitor or their combinations vein infusion

EXPERIMENTAL

Regular IV infusion of PD1/PDL1/CTLA4 inhibitor or their combinations in 30 minutes.

Drug: PD1/PDL1 inhibitor

Interventions

PD1/PDL1 inhibitor DRUG

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

Also known as: Administration of PD1/PDL1 inhibitor through vein or interventional technique.

PD1/PDL1/CTLA4 inhibitor or their combinations hepatic artery infusion; PD1/PDL1/CTLA4 inhibitor or their combinations vein infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, 51260, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Hui Lian, MD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Zhenfeng Zhang, MD, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Lian, MD

CONTACT

02034153532; lian-hui-2008@163.com

Zhenfeng Zhang, MD, PhD

CONTACT

+862039195966; zhangzhf@gzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 14, 2019
• Study Start: January 1, 2019
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 2, 2038
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CN (1)