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

• Status: Not yet recruiting
• Trial end date: 2023-01-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.