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

Phase 1

• Conditions: HER-2 Positive Colorectal Cancer
• Interventions: Drug: Pyrotinib in combination with capecitabine

• Registration Number: NCT04227041
• Lead Sponsor: Qingdao Zhixin Health Technology Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-10
• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-12
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-14
• Primary Completion: 2021-01-10
• Study Completion: 2023-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HER2 positive metastatic colorectal cancer	Pyrotinib in combination with capecitabine	-

Primary Outcome Measures

Name	Time	Method
Maximally Tolerated Dose (MTD)	up to 36 months	Evaluation of tumor burden based on RECIST criteria.
Progression-free survival (PFS)	up to 36 months	Evaluation of tumor burden based on RECIST criteria.

Secondary Outcome Measures

Name	Time	Method
Duration Of Response (DOR)	up to 36 months	Evaluation of tumor burden based on RECIST criteria.
Disease Control Rate (DCR)	up to 36 months	Evaluation of tumor burden based on RECIST criteria.
Incidence of Treatment-Emergent Adverse Events [Safety]	up to 36 months
Objective Response Rate (ORR)	up to 36 months	Evaluation of tumor burden based on RECIST criteria.

Trial Locations

Locations (1)

Qingdao University Hospital; 🇨🇳 Qingdao, Shandong, China