Colorectal Cancer
Conditions
Keywords
ALK mutation, ALK inhibitor, Metastatic Colorectal Cancer
Brief summary
This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.
Interventions
OTHERALK Inhibitor
Any ALK inhibitor like crizotinib, alectinib and so on.
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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;
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Respone Rate(ORR) | up to 36months | Evaluation of tumor burden based on RECIST criteria every 2 month. |
Countries
China
Outcome results
None listed