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Recruiting Phase 2, Phase 3 NCT06478108

Interventional Software for Multi-immunotherapy of Solid Tumors

Trial Parameters

Condition Lung Cancer
Sponsor Second Affiliated Hospital of Guangzhou Medical University
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-04-01
Completion 2028-12-30
Interventions
IRSW-MIM

Brief Summary

This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and/or PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.

Eligibility Criteria

Inclusion Criteria: 1. Cytohistological confirmation is required for diagnosis of cancer. 2. Signed informed consent before recruiting. 3. Age above 18 years with estimated survival over 3 months. 4. Child-Pugh class A or B/Child score \> 7; ECOG score \< 2 5. Tolerable coagulation function or reversible coagulation disorders 6. 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 7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1. 8. Birth control. 9. Willing and able to comply with scheduled visits, treatment plan and laboratory tests. Exclusion Criteria: 1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks; 2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding; 3. Any serious accompany

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