Trial | NCT04227041  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    34
To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.
Study Started
Jan 10
2020
Anticipated
Primary Completion
Jan 10
2021
Anticipated
Study Completion
Jan 10
2023
Anticipated
Last Update
Jan 14
2020

Drug Pyrotinib in combination with capecitabine [capecitabine (xeloda), pyrotinib]

Pyrotinib in combination with capecitabine

  • Other names: Capecitabine

HER2 positive metastatic colorectal cancer Experimental

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.
No Results Posted