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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04227041

Enrollment

Registered

2020-01-13

Start date

2020-01-10

Completion date

2023-01-10

Last updated

2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER-2 Positive Colorectal Cancer

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.

Interventions

DRUGPyrotinib in combination with capecitabine

Pyrotinib in combination with capecitabine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Objective Response Rate (ORR)	up to 36 months	Evaluation of tumor burden based on RECIST criteria.
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	—

Countries

China

Contacts

Primary ContactTao Jiang, Dr.

jiangtao111@sina.com18661806663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026