NCT05993858 (PC-1) is a Phase 2 clinical trial of 3cycles (Toripalimab + cetuximab) in Head and Neck Squamous Cell Carcinoma, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

What drugs are being tested in NCT05993858?

Interventions in NCT05993858: 3cycles (Toripalimab + cetuximab), Surgery, Radiotherapy or chemoradiotherapy.

What condition does NCT05993858 study?

NCT05993858 studies Head and Neck Squamous Cell Carcinoma, Neoadjuvant Therapy.

Is NCT05993858 still recruiting?

NCT05993858 is currently not yet recruiting. Last updated 15 August 2023.

Last reviewed 2023-08-15 · How we verify

NCT05993858: PC-1

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

Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced HNSCC

Not yet recruiting Phase 2 Last updated 15 August 2023

What this trial tests

Phase 2 trial testing 3cycles (Toripalimab + cetuximab) in Head and Neck Squamous Cell Carcinoma in 33 participants. Not yet recruiting.

Timeline

20 October 2023

Primary endpoint
20 December 2025

20 December 2026

Quick facts

Lead sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	20 October 2023
Primary completion	20 December 2025
Estimated completion	20 December 2026
Sites	1 location across China

Drugs / interventions tested

3cycles (Toripalimab + cetuximab) — full drug profile →
Surgery
Radiotherapy or chemoradiotherapy

Conditions studied

Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Who can join

Adults 18 to 70, any sex, with Head and Neck Squamous Cell Carcinoma or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-center, single-arm, phase II clinical study to evaluate the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC.

Publications & conference data

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

Single-cell RNA sequencing: enhancing the predictive accuracy of tumor immunotherapy efficacy.
Zhou W, Huang Z, Wu Z, Tang M, et al · · 2025 · cited 3× · PMID 40857744 · DOI 10.1042/ebc20253017
[Application of neoadjuvant immunotherapy in head and neck squamous cell carcinoma: From mechanisms to clinical practice].
Chen J, Zhang J, Kuang Y, Chen Y, et al · · 2025 · PMID 42032983 · DOI 10.11817/j.issn.1672-7347.2025.250271

Verify or expand the search:

Other recruiting trials for Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT06995508 — Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial · Phase 2 · recruiting
NCT07254585 — SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma · Phase 2 · recruiting
NCT07514754 — Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients · NA · recruiting

Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials

Trials by the same sponsor.

NCT07521124 — ABC Maintenance Therapy for AML · NA · not yet recruiting
NCT07497243 — X-ray Assisted Diagnostic System · not yet recruiting
NCT07520123 — Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatiti · NA · not yet recruiting
NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · 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 NCT05993858 (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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Last refreshed: 15 August 2023

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/NCT05993858.

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