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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03192501
• Other study ID #: ZZiCAGES-001
• Status: Recruiting
• Start date: July 1, 2017
• Est. completion date: July 1, 2029

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Zhenfeng Zhang, MD,PhD
• Phone: +86-020-34153532
• Email: zhangzhf[@]gzhmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 1, 2029
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Pathological and clinical diagnosis of recurrence / metastatic lung cancer or other advanced cancers.

• There are PACS images available at the Second Affiliated Hospital of Guangzhou Medical University and the collaborated Hospitals.

• The patient is informed consent and signed a written consent.

Exclusion Criteria:

• Age > 70 or <18 years old.

• Previous history of malignant tumors.

• Pregnant or lactating female patients.

• Any serious concomitant disease that is expected to have an adverse effect on prognosis, including the heart disease that treatment is required, unsatisfactory controlled diabetes and psychiatric disorders.

Related Conditions & MeSH terms

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

Intervention

Drug:
• inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group.
Choose appropriate targeted drugs according to NGS/IHC results.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University	Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Dong C, Guo Y, Yang H, He Z, Liu X, Wang K. iCAGES: integrated CAncer GEnome Score for comprehensively prioritizing driver genes in personal cancer genomes. Genome Med. 2016 Dec 22;8(1):135. doi: 10.1186/s13073-016-0390-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	The PFS will be recorded during the follow up time.	2 years
Primary	OS	The OS will be recorded during the follow up time.	2 years
Secondary	Quality of life.	Physicians Global Assessment to measure quality of life	2 years
Secondary	Pain	Visual Analog Score for pain	one year

External Links

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