NCT04380012 is a Phase 2 clinical trial of Pyrotinib in Colorectal Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University.

Who is sponsoring NCT04380012?

NCT04380012 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University.

What drugs are being tested in NCT04380012?

Interventions in NCT04380012: Pyrotinib, Pyrotinib in combination with trastuzumab.

What condition does NCT04380012 study?

NCT04380012 studies Colorectal Cancer.

Is NCT04380012 still recruiting?

NCT04380012 is currently status unknown. Last updated 15 July 2021.

Last reviewed 2021-07-15 · How we verify

NCT04380012

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Study of Pyrotinib in Patients With HER2-positive Advanced Colorectal Cancer

Status unknown Phase 2 Last updated 15 July 2021

What this trial tests

Phase 2 trial testing Pyrotinib in Colorectal Cancer in 40 participants. Status unknown.

Timeline

17 December 2019

Primary endpoint
17 December 2021

17 June 2022

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	17 December 2019
Primary completion	17 December 2021
Estimated completion	17 June 2022
Sites	1 location across China

Drugs / interventions tested

Pyrotinib — full drug profile →
Pyrotinib in combination with trastuzumab — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 75, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With HER2-positive Advanced Colorectal Cancer

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Structural Insight and Development of EGFR Tyrosine Kinase Inhibitors.
Amelia T, Kartasasmita RE, Ohwada T, Tjahjono DH. · · 2022 · cited 83× · PMID 35164092 · DOI 10.3390/molecules27030819
Mechanisms of immune modulation in the tumor microenvironment and implications for targeted therapy.
Czajka-Francuz P, Prendes MJ, Mankan A, Quintana Á, et al · · 2023 · cited 46× · PMID 37427115 · DOI 10.3389/fonc.2023.1200646
Beyond RAS and BRAF: HER2, a New Actionable Oncotarget in Advanced Colorectal Cancer.
Guarini C, Grassi T, Pezzicoli G, Porta C. · · 2021 · cited 26× · PMID 34202896 · DOI 10.3390/ijms22136813
Dual targeted therapy with pyrotinib and trastuzumab for HER2-positive advanced colorectal cancer: A phase 2 trial.
Fu X, Ying J, Yang L, Fang W, et al · · 2023 · cited 22× · PMID 36382603 · DOI 10.1111/cas.15660
Emerging Role of ERBB2 in Targeted Therapy for Metastatic Colorectal Cancer: Signaling Pathways to Therapeutic Strategies.
Wang N, Cao Y, Si C, Shao P, et al · · 2022 · cited 18× · PMID 36291943 · DOI 10.3390/cancers14205160
Personalizing first-line treatment in advanced colorectal cancer: Present status and future perspectives.
Motta R, Cabezas-Camarero S, Torres-Mattos C, Riquelme A, et al · · 2021 · cited 12× · PMID 34988329
Molecular Basis of HER2-Targeted Therapy for HER2-Positive Colorectal Cancer.
Yoshikawa A, Nakamura Y. · · 2022 · cited 10× · PMID 36612185 · DOI 10.3390/cancers15010183
HER2-targeted therapy in colorectal cancer: a comprehensive review.
Benli Y, Arıkan H, Akbulut-Çalışkan Ö. · · 2025 · cited 4× · PMID 40087250 · DOI 10.1007/s12094-025-03887-0

Verify or expand the search:

Other trials of Pyrotinib

Trials testing the same drug.

NCT06495541 — The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive · NA · not yet recruiting
NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
NCT07340398 — Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Subop · Phase 2 · recruiting
NCT07179939 — Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study · Phase 2 · not yet recruiting

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials

Trials by the same sponsor.

NCT07445152 — Research on Construction and Verification of Multimodal Medical Imaging Large Model · not yet recruiting
NCT06775665 — A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population · not yet recruiting
NCT07533422 — Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing · NA · not yet recruiting
NCT07487285 — A Non-inferiority Study of Laser Combined With Ultrasonic Debridement Therapy (LCUDT) Versus Manual Combined With Ultras · NA · not yet recruiting
NCT07505186 — Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04380012 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
Last refreshed: 15 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04380012.

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