Status:
RECRUITING
Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Lung Cancer
Inoperable Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Antibodies against CTLA4, PD1 and PDL1 are representative drugs for the check-points inhibitory agents, and their clinical indications have been approved in various types of tumors, including advanced...
Eligibility Criteria
Inclusion
- Cytohistological confirmation is required for diagnosis of cancer.
- Signed informed consent before recruiting.
- Age above 18 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.
- Birth control.
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Exclusion
- 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).
- Allergic to contrast agent;
- Any agents which could affect the absorption or pharmacokinetics of the study drugs
- Other conditions that investigator decides not suitable for the trial.
Key Trial Info
Start Date :
April 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2033
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06483347
Start Date
April 4 2024
End Date
December 30 2033
Last Update
July 3 2024
Active Locations (1)
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1
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China