A Phase 2 interventional study of Pyrotinib and Pyrotinib in combination with trastuzumab in Colorectal Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-15.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2, Interventional, and Treatment
To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With HER2-positive Advanced Colorectal Cancer
This study is an investigator-initiated, open-label, two-cohort phase II trial, assessing the objective response rate (ORR) of pyrotinib monotherapy (Cohort 1) or in combination with trastuzumab (Cohort 2), in HER2-positive advanced colorectal cancer.
HER2 positivity is centrally established by immunohistochemistry (IHC) and silver in situ hybridization (SISH). To be HER2 eligible the original tumor, or the biopsied metastasis (whichever is last available), must be IHC 3+ or 2+ in more than 50% of cells, confirmed by SISH or fluorescence in situ hybridization (FISH) with a HER2:CEP17 ratio ≥ 2.0. For IHC a positive staining (3+) is defined as an intense membrane staining which can be circumferential, basolateral, or lateral of the tumor cells.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 40 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
7.The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes- or platelet-raising drugs):
Exclusion Criteria:
Pyrotinib: 400 mg, po, qd, 21d for a treatment cycle
Drug: Pyrotinib
Pyrotinib: 400 mg, po, qd, 21d for one treatment cycle; Trastuzumab: first dose 8 mg/kg, then 6 mg/kg, iv, q3w, 21d for one treatment cycle
Drug: Pyrotinib in combination with trastuzumab
Pyrotinib as interventions were used in patients with HER2-positive advanced colorectal cancer
Pyrotinib in combination with trastuzumab as interventions were used in patients with HER2-positive advanced colorectal cancer
Objective Response Rate
The proportion of patients with complete response or partial response according to RECIST v1.1.
Time frame: Approximately 24 months
Disease Control Rate
The proportion of patients with complete response, partial response or stable disease according to RECIST v1.1.
Time frame: Approximately 24 months
Progression-Free Survival
Time from the initiation of treatment to disease progression or any-cause death.
Time frame: Up to 2 years
Overall Survival
Time from the initiation of treatment to any-cause death.
Time frame: Up to 2 years
Duration of Response
Time from complete response or partial response to disease progression or any-cause death.
Time frame: Approximately 24 months
The Incidence of Adverse Events
Adverse Events and Serious Adverse Events were graded according to the NCI-CTCAE V5.0.
Time frame: From the first drug administration to within 28 days for the last treatment
Plan to share: Undecided — The data were Shared with the sub-center, and the preliminary efficacy results were to be submitted to the tumor conference
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University