Actively Recruiting
Infusion of PD1/PDL1/CTLA4 Inhibitors Via Hepatic Arterial for Immunotherapy of Hepatocellular Carcinoma
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-26
200
Participants Needed
1
Research Sites
991 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Infusion of PD1/PDL1/CTLA4 Inhibitors Via Hepatic Arterial for Immunotherapy of Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hepatocellular carcinoma confirmed by tissue or cytology
- Signed informed consent before joining the study
- Aged between 18 to 80 years with estimated survival over 3 months
- Liver function Child-Pugh class A or B with Child score above 7; ECOG performance status less than 2
- Coagulation function tolerable or reversible coagulation disorders
- Laboratory tests within 7 days before procedure: WBC ≥ 3.0 x10^9/L; Hb ≥ 90 g/L; PLT ≥ 50 x10^9/L; INR < 2.3 or PT < 6 seconds above control; creatinine ≤ 145.5 umol/L; albumin > 28 g/L; total bilirubin < 51 µmol/L
- At least one measurable tumor lesion by RECIST v1.1 criteria
- Advanced (unresectable and/or metastatic, stage C by BCLC classification) hepatocellular carcinoma not suitable for or progressed after locoregional therapies
- Use of birth control
- Willing and able to comply with scheduled visits, treatment plan, and laboratory tests
You will not qualify if you...
- Participation in any clinical trials of drugs or equipment within 4 weeks
- Presence of ascites, hepatic encephalopathy, or bleeding from esophageal and gastric varices
- Serious accompanying diseases affecting prognosis, including heart disease, uncontrolled diabetes, or psychiatric disorders
- Other tumors or past history of malignancy
- Pregnant or lactating patients; all participants must use birth control during treatment
- Poor compliance
- Contraindications to hepatic arterial infusion: impaired clotting (platelet count < 60000/mm3, prothrombin activity < 50%), renal failure requiring dialysis, severe atheromatosis, uncontrolled hypertension (>160/100 mmHg)
- Past history of liver cancer treatments such as transplantation, resection, radiotherapy, or chemotherapy
- Allergy to adriamycin chemotherapy drugs, contrast agents, or lipiodol
- Use of agents affecting absorption or pharmacokinetics of study drugs
- Inability to tolerate discomfort from hepatic arterial infusion procedure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, China, 51260
Actively Recruiting
Research Team
H
Hui Lian, MD
CONTACT
Z
Zhenfeng Zhang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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