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

HER-2 Positive Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04227041
• Other study ID #: QingdaoZHT
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 10, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: January 2020
• Source: Qingdao Zhixin Health Technology Co., Ltd.
• Contact: Tao Jiang, Dr.
• Phone: 18661806663
• Email: jiangtao111[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: January 10, 2023
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?, 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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• HER-2 Positive Colorectal Cancer

Intervention

Drug:
• Pyrotinib in combination with capecitabine
Pyrotinib in combination with capecitabine

Locations

Country	Name	City	State
China	Qingdao University Hospital	Qingdao	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qingdao Zhixin Health Technology Co., Ltd.	The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

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