Clinical trial · Interventional
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
NCT04227041CI-TRIAL-00042794unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER-2 Positive Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib in combination with capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HER2 positive metastatic colorectal cancer
- interventionNames
- Drug: Pyrotinib in combination with capecitabine
Primary outcomes (2)
- measure
- Maximally Tolerated Dose (MTD)
- timeFrame
- up to 36 months
- description
- Evaluation of tumor burden based on RECIST criteria.
- measure
- Progression-free survival (PFS)
- timeFrame
- up to 36 months
- description
- Evaluation of tumor burden based on RECIST criteria.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.