Who is sponsoring NCT04960943?

NCT04960943 is sponsored by Fudan University.

What drugs are being tested in NCT04960943?

Interventions in NCT04960943: Pyrotinib with or without trastuzumab.

What condition does NCT04960943 study?

NCT04960943 studies Gastrointestinal Tumor, Effect of Drug.

Is NCT04960943 still recruiting?

NCT04960943 is currently status unknown. Last updated 14 July 2021.

Last reviewed 2021-07-14 · How we verify

NCT04960943

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

Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

Status unknown Phase 2 Last updated 14 July 2021

What this trial tests

Phase 2 trial testing Pyrotinib with or without trastuzumab in Gastrointestinal Tumor in 60 participants. Status unknown.

Timeline

1 February 2020

Primary endpoint
9 September 2022

1 March 2023

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 February 2020
Primary completion	9 September 2022
Estimated completion	1 March 2023
Sites	1 location across China

Drugs / interventions tested

Pyrotinib with or without trastuzumab — full drug profile →

Conditions studied

Gastrointestinal Tumor — all drugs for Gastrointestinal Tumor →
Effect of Drug — all drugs for Effect of Drug →

Sponsor

Fudan University

Who can join

18 and older, any sex, with Gastrointestinal Tumor or Effect of Drug. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Targeting human epidermal factor receptor 2 (HER2) therapy have shown the anti-tumor efficacy in patients with HER2-positive gastrointestinal tumors. Pyrotinib is an irreversible small-molecule receptor tyrosine kinase inhibitor targeting both epidermal growth factor receptor (EGFR) and HER2. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive gastrointestinal tumors.

Publications & conference data

5 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
Dual HER2 Targeted Therapy With Pyrotinib and Trastuzumab in Refractory HER2 Positive Metastatic Colorectal Cancer: A Result From HER2-FUSCC-G Study.
Chang J, Xu M, Wang C, Huang D, et al · · 2022 · cited 27× · PMID 35941028 · DOI 10.1016/j.clcc.2022.07.003
History and Future of HER2-Targeted Therapy for Advanced Gastric Cancer.
Ariga S. · · 2023 · cited 12× · PMID 37240498 · DOI 10.3390/jcm12103391
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
Targeting HER2 in Metastatic Colorectal Cancer: Current Therapies, Biomarker Refinement, and Emerging Strategies.
Vaghi C, Tosi F, Mauri G, Bonazzina E, et al · · 2026 · cited 2× · PMID 41247589 · DOI 10.1007/s40265-025-02253-2

Verify or expand the search:

Other recruiting trials for Gastrointestinal Tumor

Currently open trials in the same condition.

NCT06190730 — REmote Symptom COllection to improVE postopeRative Care · NA · recruiting
NCT04960072 — A Study of GC101 TIL in r/r Gastrointestinal Tumors (10hospital) · EARLY_PHASE1 · recruiting

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · 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 NCT04960943 (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 Fudan University
Last refreshed: 14 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/NCT04960943.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing