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

January 12, 2020 updated by: Nailong Yang, Qingdao Zhixin Health Technology Co., Ltd.

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

To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China
        • Qingdao University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
  2. Patients with HER2 positive；
  3. Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
  4. Life expectancy is at least 6 months
  5. ECOG score 0-1；
  6. 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:

  1. The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
  2. Patients who have previously been treated with anti-Her2-targeted drugs；
  3. Patients with surgical opportunity or potential for surgical treatment；
  4. 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；
  5. Patients with any severe and/or uncontrolled disease;
  6. Patients with any or present brain metastases；
  7. Women who were pregnant or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HER2 positive metastatic colorectal cancer
Drug: Pyrotinib in combination with capecitabine
Pyrotinib in combination with capecitabine
Other Names:
  • Capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximally Tolerated Dose (MTD)
Time Frame: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
up to 36 months
Progression-free survival (PFS)
Time Frame: up to 36 months
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)
Time Frame: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
up to 36 months
Duration Of Response (DOR)
Time Frame: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
up to 36 months
Disease Control Rate (DCR)
Time Frame: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
up to 36 months
Incidence of Treatment-Emergent Adverse Events [Safety]
Time Frame: up to 36 months
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Zhixin Health Technology Co., Ltd.

Collaborators

The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 10, 2020

Primary Completion (Anticipated)

January 10, 2021

Study Completion (Anticipated)

January 10, 2023

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QingdaoZHT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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