Colorectal Cancer
Conditions
Keywords
HER2, Pyrotinib, Trastuzumab, Metastatic Colorectal Cancar
Brief summary
This clinical trial aims to evaluate the efficacy, safety of Pyrotinib in combination with trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
Interventions
DRUGPyrotinib
Pyrotinib in Combination With Trastuzumab
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 75 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 Response Rate(ORR) | up to 36 months | Evaluation of tumor burden based on RECIST criteria. |
Countries
China
Outcome results
None listed