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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

In this study, all the patients will be recruited from the Second Affiliated Hospital of Guangzhou Medical University and the collaborated Hospitals during 01/07/2017 to 01/07/2019, 250 advanced patients (90 cases for A group, 70 cases for B group, and 90 cases for C group) are anticipated to be collected. All the patients are more than 18 years old and less than 75 years old. The follow-up will be performed every 2 month until 2 years after the first treatment post-recruitment or quit.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group.

    Drug

    Choose appropriate targeted drugs according to NGS/IHC results.

Treatment groups

250 Participants
are divided into 3 treatment groups
Group A: Study group (A group)1 intervention
Group B: Control group (B group)0 interventions
Group C: Control group (C group)1 intervention

Trial outcomes

Primary outcomes

1

PFS

The PFS will be recorded during the follow up time.

Time frame
2 years
2

OS

The OS will be recorded during the follow up time.

Time frame
2 years

Secondary outcomes

1

Quality of life.

Physicians Global Assessment to measure quality of life

Time frame
2 years
2

Pain

Visual Analog Score for pain

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Guangzhou Medical University

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Collaborator

Sun Yat-sen University

Collaborator