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Clinical Trials/NCT04227041
NCT04227041UnknownPhase 1

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

Qingdao Zhixin Health Technology Co., Ltd.1 site in 1 country34 target enrollmentStarted: January 10, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Enrollment
34
Locations
1
Primary Endpoint
Maximally Tolerated Dose (MTD)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens;
  • Patients with HER2 positive;
  • Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1);
  • Life expectancy is at least 6 months
  • ECOG score 0-1;
  • 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

  • The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis;
  • Patients who have previously been treated with anti-Her2-targeted drugs;
  • Patients with surgical opportunity or potential for surgical treatment;
  • 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;
  • Patients with any severe and/or uncontrolled disease;
  • Patients with any or present brain metastases;
  • Women who were pregnant or breast-feeding.

Arms & Interventions

HER2 positive metastatic colorectal cancer

Experimental

Intervention: Pyrotinib in combination with capecitabine (Drug)

Outcomes

Primary Outcomes

Maximally Tolerated Dose (MTD)

Time Frame: up to 36 months

Evaluation of tumor burden based on RECIST criteria.

Progression-free survival (PFS)

Time Frame: up to 36 months

Evaluation of tumor burden based on RECIST criteria.

Secondary Outcomes

  • Duration Of Response (DOR)(up to 36 months)
  • Disease Control Rate (DCR)(up to 36 months)
  • Incidence of Treatment-Emergent Adverse Events [Safety](up to 36 months)
  • Objective Response Rate (ORR)(up to 36 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nailong Yang

Principal Investigator

The Affiliated Hospital of Qingdao University

Study Sites (1)

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