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A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study

NCT02013089 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-08-30

No results posted yet for this study

Summary

Hypothesis: Different patients have different biomarkers, if doctors know about the biomarkers of patients; they may be able to prescribe a regimen that is better suited to the patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer who had failed from all standard and available regimens.

Conditions

Interventions

DRUG

Erlotinib or Gefitinib

Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation

DRUG

Everolimus

Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation

DRUG

Imatinib

Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation

DRUG

Sorafenib or Sunitinib

Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day with or without food for patients with VEGFR, KIT, RAF gene alternation

DRUG

Vandetanib

Vandetanib 300 mg orally once daily for patients with RET gene fusion.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yanghong Deng, PhD · Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-05-31
Completion
2017-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013089 on ClinicalTrials.gov