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

Qingdao Zhixin Health Technology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: HER-2 Positive Colorectal Cancer

Treatments: Drug: Pyrotinib in combination with capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT04227041

QingdaoZHT

Details and patient eligibility

About

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

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

HER2 positive metastatic colorectal cancer

Experimental group

Treatment:

Drug: Pyrotinib in combination with capecitabine