NCT03192501

iCAGES-guided Precision Therapy for Cancers in Contrast to Standard Care or IHC-guided Theray

Multicentre Perspective Non-interventional Study of Survival Benefits of iCAGES-guided Therapy in Contrast to Standard Therapy or IHC-guided Therapy for Advanced Cancers

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study prospectively evaluates whether the use of iCAGES (integrated CAncer GEnome Score) tool in guiding the treatment of advanced cancers is superior to current standard care or IHC-guided therapy in progress free survival (PFS),overall survival (OS),and improvement of life quality.

Detailed description

Cancer is a fatal disease caused by the accumulation of various oncogene and tumor suppressor gene mutations. Studies of high-throughput sequencing for patients who suffered from cancer has found that different mutations play a different role in the occurrence and development of different cancers. Several gene panels already exist to help identify mutations in a few genes that may have corresponding FDA-approved drugs or drugs under clinical trials. However, given whole-genome/exome sequencing data, the suitable clinical analysis tool to analyze individualized cancer-related gene mutations, and recommend the most appropriate targeted treatment options among hundreds of possible drugs therapy is absent currently. The recently proposed iCAGES is a precise biomedical informatics analysis tool, which could help increase the accuracy of cancer driver gene detection and prioritization, bridge the gap between personal cancer genomic data and prior cancer research knowledge,and facilitate cancer molecular diagnosis as well as personalized precision therapy. IHC detection of multiple molecules such as EGFR, HER2-3, TROP3, NECTIN4, MET, B7-H3-4, B1-H7, Claudin18.2, FGFR1-4, Mesothelin, ROR1, BCMA, AXL, TF, FRα, CD70, PPARα, HIF-2α, RET, ROS1, NTRK, CDK4/6, FLT3, EZH2 are also scheduled for appropriate targeted therapy and comparison if available.

Conditions

• Lung Cancer
• Gene Abnormality
• Gene Product Sequence Variation
• Cancer

Interventions

Type	Name	Description
DRUG	inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group.	Choose appropriate targeted drugs according to NGS/IHC results.

Timeline

• Start date: 2017-07-01
• Primary completion: 2030-07-01
• Completion: 2039-07-01
• First posted: 2017-06-20
• Last updated: 2024-06-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study