Colorectal Cancer Clinical Trial
Official title:
Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
NCT number | NCT03843749 |
Other study ID # | PTHMC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | July 1, 2022 |
Verified date | February 2019 |
Source | Shanghai Changzheng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial aims to evaluate the efficacy, safety of Pyrotinib in combination with trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Changzheng Hospital | Shanghai | Shanghai |
China | Shanghai Changzheng Hospital | Shanghai | Shanghai |
China | Shanghai Changzheng Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Changzheng Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate(ORR) | Evaluation of tumor burden based on RECIST criteria. | up to 36 months |
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