NCT05661357 (HCCSC-C03) is a Phase 4 clinical trial of Disitamab Vedotin Combined With Fruquintinib in HER2, sponsored by Zhongnan Hospital.

Who is sponsoring NCT05661357?

NCT05661357 is sponsored by Zhongnan Hospital.

What drugs are being tested in NCT05661357?

Interventions in NCT05661357: Disitamab Vedotin Combined With Fruquintinib.

What condition does NCT05661357 study?

NCT05661357 studies HER2, Colorectal Cancer.

Is NCT05661357 still recruiting?

NCT05661357 is currently status unknown. Last updated 17 April 2024.

Last reviewed 2024-04-17 · How we verify

NCT05661357: HCCSC-C03

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

Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression

Status unknown Phase 4 Last updated 17 April 2024

What this trial tests

Phase 4 trial testing Disitamab Vedotin Combined With Fruquintinib in HER2 in 51 participants. Status unknown.

Timeline

1 January 2023

Primary endpoint
31 January 2025

31 December 2025

Quick facts

Lead sponsor	Zhongnan Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	1 January 2023
Primary completion	31 January 2025
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

Disitamab Vedotin Combined With Fruquintinib — full drug profile →

Conditions studied

HER2 — all drugs for HER2 →
Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Zhongnan Hospital

Who can join

Adults 18 to 75, any sex, with HER2 or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Single arm, prospective, exploratory clinical study of Disitamab Vedotin combined with Fruquintinib for advanced colorectal cancer with HER2 expression or mutation that has received at least two standard treatment failures

Publications & conference data

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

Treatment options for HER2-expressing colorectal cancer: updates and recent approvals.
Zheng-Lin B, Bekaii-Saab TS. · · 2024 · cited 12× · PMID 38249334 · DOI 10.1177/17588359231225037
Evaluation of Fruquintinib in the Continuum of Care of Patients with Colorectal Cancer.
Lavacchi D, Roviello G, Guidolin A, Romano S, et al · · 2023 · cited 10× · PMID 36982913 · DOI 10.3390/ijms24065840
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
Clinical Progress of Fruquintinib in Colorectal Cancer: An Overview.
Xie Y, Tang S, Qin Z, Yang C. · · 2025 · cited 3× · PMID 40006092 · DOI 10.3390/ph18020280
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
Colorectal cancer pathogenesis, oncogenic signaling networks and targeted therapeutic advances.
Chen Y, Zhang J, Ding Y, Zhu F, et al · · 2026 · PMID 41826571 · DOI 10.1186/s43556-026-00433-4

Verify or expand the search:

Other recruiting trials for HER2

Currently open trials in the same condition.

NCT07356544 — Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC · recruiting
NCT07285941 — Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatmen · Phase 2 · recruiting
NCT07030569 — RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study · recruiting
NCT05957757 — RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression · Phase 2 · recruiting

Other Zhongnan Hospital trials

Trials by the same sponsor.

NCT07515963 — FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases. · Phase 2 · not yet recruiting
NCT07420036 — An Open-label, Single-arm, Single-center Study to Evaluate the Diagnostic Efficacy of a Novel PET Probe, 68Ga-SFB6-ZN01, · EARLY_PHASE1 · not yet recruiting
NCT07453966 — Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mec · NA · recruiting
NCT07363330 — A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer · Phase 2 · not yet recruiting
NCT07460258 — A Study on the Effect of Medical Students' Literature Reading Patterns on Cognitive Load and Academic Writing Ability · 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 NCT05661357 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Zhongnan Hospital
Last refreshed: 17 April 2024

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/NCT05661357.

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