Infusion of PD1/PDL1/CTLA4 Inhibitors Via Hepatic Arterial for Immunotherapy of Hepatocellular Carcinoma
Recruiting now · Phase 3
Conditions studied: Liver Cancer
In brief
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.
Key facts
- Study ID
- NCT03949231
- Run by
- Second Affiliated Hospital of Guangzhou Medical University
- People needed
- 200
- Starts
- 2019-01-01
- Expected to finish
- 2038-01-02
- Last updated by the study team
- 2024-06-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- The Second Affiliated Hospital of Guangzhou Medical University — Guanzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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