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

Sponsor
Sun Yat-sen University
Study ID
NCT02013089
Status
Unknown

Conditions

  • Gastrointestinal Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib or Gefitinib — DRUG
    Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation
  • Everolimus — DRUG
    Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation
  • Imatinib — DRUG
    Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation
  • Sorafenib or Sunitinib — DRUG
    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
  • Vandetanib — DRUG
    Vandetanib 300 mg orally once daily for patients with RET gene fusion.

Study Details

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.

Key Dates

First listed
Dec 17, 2013
Start date
Dec 31, 2013
Status verified
Aug 2016
Primary completion
May 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib or Gefitinib
    Erlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day
  • Experimental: Everolimus
    Everolimus 10 mg orally once daily every day
  • Experimental: Imatinib
    Imatinib 400 mg tablet orally per day
  • Experimental: 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
  • Experimental: Vandetanib
    Vandetanib 300 mg orally once daily
  • No Intervention: Control
    No intervention was performed for patients without any gene alternation or without any available target agents

Primary Outcome Measure

Overall survival [ Time Frame: 1 year ]

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