NCT04227041UnknownPhase 1
Single-arm, Prospective, Open-label, Exploratory Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer Patients After at Least Second-line Standard Treatment
Qingdao Zhixin Health Technology Co., Ltd.1 site in 1 country34 target enrollmentStarted: January 10, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Maximally Tolerated Dose (MTD)
Study Overview
Brief Summary
To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
- •Patients with HER2 positive；
- •Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
- •Life expectancy is at least 6 months
- •ECOG score 0-1；
- •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 platelets)：
Exclusion Criteria
- •The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
- •Patients who have previously been treated with anti-Her2-targeted drugs；
- •Patients with surgical opportunity or potential for surgical treatment；
- •Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
- •Patients with any severe and/or uncontrolled disease;
- •Patients with any or present brain metastases；
- •Women who were pregnant or breast-feeding.
Arms & Interventions
HER2 positive metastatic colorectal cancer
Experimental
Intervention: Pyrotinib in combination with capecitabine (Drug)
Outcomes
Primary Outcomes
Maximally Tolerated Dose (MTD)
Time Frame: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
Progression-free survival (PFS)
Time Frame: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
Secondary Outcomes
- Duration Of Response (DOR)(up to 36 months)
- Disease Control Rate (DCR)(up to 36 months)
- Incidence of Treatment-Emergent Adverse Events [Safety](up to 36 months)
- Objective Response Rate (ORR)(up to 36 months)
Investigators
Nailong Yang
Principal Investigator
The Affiliated Hospital of Qingdao University
Study Sites (1)
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