Clinical trial · Interventional
A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study
A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancers | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib or Gefitinib | Drug | — | UNRESOLVED |
| Everolimus | Drug | Everolimus | ALIAS |
| Imatinib | Drug | Imatinib | ALIAS |
| Sorafenib or Sunitinib | Drug | — | UNRESOLVED |
| Vandetanib | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Erlotinib or Gefitinib
- description
- Erlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day
- interventionNames
- Drug: Erlotinib or Gefitinib
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- Everolimus 10 mg orally once daily every day
- interventionNames
- Drug: Everolimus
- type
- EXPERIMENTAL
- label
- Imatinib
- description
- Imatinib 400 mg tablet orally per day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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) \</= 2.5 \* the upper limit of normal or \</= 5.0 \* ULN if 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.
References
Publications (0)
Data not yet available