Actively Recruiting
Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25
200
Participants Needed
1
Research Sites
939 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery/intra-tumor infusion of PD1/PDL1 antibody and/or CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences.
CONDITIONS
Official Title
Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of cancer by tissue or cell testing
- Signed informed consent before joining the study
- Age 18 years or older with expected survival over 3 months
- Child-Pugh class A or B with Child score greater than 7; ECOG score less than 2
- Able to tolerate coagulation function or have reversible coagulation disorders
- Laboratory tests within 7 days before procedure showing: WBC ≥ 3.0 x10^9/L; Hb ≥ 90 g/L; PLT ≥ 50 x10^9/L; INR < 2.3 or PT less than 6 seconds above control; creatinine ≤ 145.5 umol/L; albumin > 28 g/L; total bilirubin < 51 µmol/L
- At least one tumor lesion measurable by RECIST v1.1
- Using birth control
- Willing and able to follow scheduled visits, treatments, and lab tests
You will not qualify if you...
- Participation in other clinical trials of drugs or equipment within the last 4 weeks
- Presence of ascites, hepatic encephalopathy, or bleeding from esophageal and gastric varices
- Serious diseases affecting prognosis such as heart disease, uncontrolled diabetes, or psychiatric disorders
- Having other tumors or previous cancer history
- Pregnant or breastfeeding; must use birth control during treatment
- Poor compliance with study requirements
- Contraindications to hepatic arterial infusion including low platelet count (<60000/mm3), low prothrombin activity (<50%), kidney failure needing dialysis, severe atheromatosis, or uncontrolled high blood pressure (>160/100 mmHg)
- Allergy to contrast agents
- Use of drugs affecting absorption or metabolism of study drugs
- Any other conditions 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
D
Deji Chen, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here