ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
- Conditions
- Colorectal Cancer
- Interventions
- Other: ALK Inhibitor
- Registration Number
- NCT03792568
- Lead Sponsor
- Shanghai Changzheng Hospital
- Brief Summary
This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;
Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALK mutation ALK Inhibitor -
- Primary Outcome Measures
Name Time Method Objective Respone Rate(ORR) up to 36months Evaluation of tumor burden based on RECIST criteria every 2 month.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China