Actively Recruiting
Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-07-03
90
Participants Needed
1
Research Sites
508 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 inoperable lung cancer by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).
CONDITIONS
Official Title
Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cytohistological confirmation of lung cancer diagnosis
- Signed informed consent before joining the study
- Age above 18 years with estimated survival over 3 months
- Child-Pugh class A or B with a score greater than 7; ECOG score less than 2
- Tolerable or reversible coagulation function disorders
- Laboratory tests within 7 days before treatment showing: WBC ≥ 3.0 x10^9/L; Hemoglobin ≥ 90 g/L; Platelets ≥ 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 based on RECIST v1.1 criteria
- Use of birth control during the study
- Willingness and ability to comply with scheduled visits, treatment plan, and lab tests
You will not qualify if you...
- Participation in other clinical trials of drugs or equipment within the past 4 weeks
- Presence of ascites, hepatic encephalopathy, or bleeding from esophageal or gastric varices
- Serious diseases affecting prognosis such as heart disease, uncontrolled diabetes, or psychiatric disorders
- Presence or history of other tumors or cancers
- Pregnancy or lactation without appropriate birth control
- Poor compliance with study requirements
- Contraindications to hepatic arterial infusion including impaired clotting (platelets < 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 the investigator deems unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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