KCT0005303
Not yet recruiting
未知
Phase 2 trial of rechallenge high-dose irinotecan with UGT1A1 genotype in refractory metastatic colorectal cancer
ational Cancer Center0 sites37 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- ational Cancer Center
- Enrollment
- 37
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Those who voluntarily and in writing consent to participate in this study
- •2\. Male and female patients over 19 years old
- •3\. Patients with histologically confirmed metastatic or recurrent colorectal cancer
- •\-Patients who received second or later\-line chemotherapy including 5\-fluorouracil, oxaliplatin, and irinotecan as anticancer drugs. Targeted therapies and immunooncology drugs are also permitted.
- •\-Adjuvant chemotherapy is considered as primary chemotherapy if relapse is confirmed within 6 months of completion.
- •\-Patients who have had a complete or partial response or have had stable lesions for more than 24 weeks through chemotherapy, including previous irinotecan.
- •\-Patients whose imaging progress has been confirmed during chemotherapy including irinotecan or within 6 months after the end of chemotherapy
- •\-Patients 12 weeks or more after the last dose of chemotherapy, including irinotecan.
- •4\. Patients with Eastern cooperative oncology group (ECOG) performance status \= 1
- •5\. Patients with an expected survival period of 12 weeks or more
Exclusion Criteria
- •1\. Pregnant or lactating women
- •2\. Patients who received chemotherapy or immunotherapy within 2 weeks prior to screening
- •3\. Patients undergoing major surgery or radiation therapy within 4 weeks prior to screening
- •4\. You have a history of malignancy within 3 years of registration. However, basal or squamous cell skin cancer, cervical epithelial tumor, breast epithelial cancer, or prostate\-specific antigen \<0\.01 ng/mL, except for prostate cancer treated with surgery or RT.
- •5\. Patients with symptomatic central nervous system metastases (except for the case where systemic corticosteroid administration was stopped at least 4 weeks prior to baseline and neurologically stable for 4 weeks or more)
- •6\. Significant cardiovascular disease, including congestive heart failure of the New York Heart Association Grade III or IV, myocardial infarction within 6 months of enrollment, unstable angina, poorly controlled heart arrhythmias, or stroke within the past 6 months.
- •7\. Child\-Pugh B or C patients with evidence of cirrhosis. In the case of HBV or HCV\-related chronic hepatitis or cirrhosis Child\-Pugh A, if the liver function is stably maintained through drug treatment, it may be registered in a clinical trial.
- •8\. Other uncontrolled concomitant medical conditions, including systemic fungal, bacterial, or viral infections
- •9\. People with the following diseases or conditions
- •\-Chronic inflammatory bowel disease
Outcomes
Primary Outcomes
Not specified
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