A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer

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.

Official Title
-----------------
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

Conditions
-----------------
HER-2 Positive Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Pyrotinib in combination with capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HER2 positive metastatic colorectal cancer<br> | Drug: Pyrotinib in combination with capecitabine<br>* Pyrotinib in combination with capecitabine<br>* Other names: Capecitabine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximally Tolerated Dose (MTD) | Evaluation of tumor burden based on RECIST criteria. | up to 36 months | 
| Progression-free survival (PFS) | Evaluation of tumor burden based on RECIST criteria. | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Evaluation of tumor burden based on RECIST criteria. | up to 36 months | 
| Duration Of Response (DOR) | Evaluation of tumor burden based on RECIST criteria. | up to 36 months | 
| Disease Control Rate (DCR) | Evaluation of tumor burden based on RECIST criteria. | up to 36 months | 
| Incidence of Treatment-Emergent Adverse Events [Safety] |  | up to 36 months |