Actively Recruiting
Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-07-09
90
Participants Needed
1
Research Sites
495 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by delivery of CTLA4 and PD1 or PDL1 antibodies combination through CT-guided intra-tumor (IT) injection.
CONDITIONS
Official Title
Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed untreated hepatocellular carcinoma (HCC). If a diagnostic biopsy exists, pre-treatment biopsy is not required. Patients with suspected HCC are eligible if pathology is confirmed before treatment.
- Suitable candidate for surgery as determined by the treating physician.
- Signed and dated informed consent according to ICH-GCP guidelines and local laws.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Adequate blood counts: absolute neutrophil count >= 1.5 x 10^9/L; hemoglobin >= 8.0 g/dL; platelets >= 100 x 10^9/L.
- Liver and kidney function within acceptable limits: total bilirubin <= 1.5 times upper limit of normal (ULN), except Gilbert syndrome patients with bilirubin < 3.0 mg/dL; creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min.
- Use of birth control.
- Willingness and ability to comply with scheduled visits, treatment, and laboratory tests.
You will not qualify if you...
- Participation in clinical trials involving equipment or drugs within 4 weeks prior.
- Presence of ascites, hepatic encephalopathy, or bleeding from esophageal or gastric varices.
- Serious accompanying diseases affecting prognosis, including heart disease, uncontrolled diabetes, or psychiatric disorders.
- History or presence of other tumors or malignancies.
- Pregnancy or lactation; must use birth control during treatment.
- Poor compliance, including impaired clotting (platelet count < 60000/mm3, prothrombin activity < 50%), renal failure requiring dialysis, severe atheromatosis, or uncontrolled high blood pressure (>160/100 mmHg).
- Allergy to contrast agents.
- Use of agents affecting absorption or pharmacokinetics of study drugs.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, China, 51260
Actively Recruiting
Research Team
Z
Zhenfeng Zhang, MD, PhD
CONTACT
B
Bingjia He, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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