Overview

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

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Erlotinib Hydrochloride
Everolimus
Gefitinib
Imatinib Mesylate
Niacinamide
Sirolimus
Sorafenib
Sunitinib
Criteria
Inclusion Criteria:

1. Pathologic diagnosis of Gastrointestinal cancer

2. The subject has a diagnosis metastatic gastrointestinal cancer, and failed from
standard treatment, and no other regimen is available.

3. The subject has measurable lesion of gastrointestinal cancer.

4. The subject's The Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

5. The subject has adequate hematologic function as defined by an absolute neutrophil
count (ANC) >/= 1,500/mm3, platelet count >/= 100,000/mm3, White Blood Count (WBC) >/=
3,000/ mm3, and hemoglobin >/= 9 g/dL.

6. The subject has adequate hepatic function as defined by a total bilirubin level 1.5 * the upper limit of normal (ULN) (bilirubin >/= 1.5 * ULN with known Gilbert's
disease is allowed), and alkaline phosphatase, aspartate aminotransferase/alanine
aminotransferase (AST/ALT) liver metastases are present.

7. Serum creatinine clearance >50ml/min, either by Cockcroft-Gault formula or 24-hour
urine collection analysis

8. The subject is >/=18 years of age.

9. The subject has signed informed consent.

10. Women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration
of study participation. Childbearing potential will be defined as women who have had
menses within the past 12 months, who have not had tubal ligation, hysterectomy or
bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant
while participating in this study, she should inform her treating physician
immediately.

Exclusion Criteria:

1. pregnant or breast-feeding.

2. Subjects will be excluded for other concurrent severe and/or uncontrolled medical
disease which could compromise participation in the study

3. without enough tumor sample for analysis.

4. Refuse to sign the informed consent.