NCT04164238 is a Phase 2 clinical trial of Toripalimab in Head and Neck Squamous Cell Carcinoma, sponsored by First Affiliated Hospital of Zhejiang University.

Who is sponsoring NCT04164238?

NCT04164238 is sponsored by First Affiliated Hospital of Zhejiang University.

What drugs are being tested in NCT04164238?

Interventions in NCT04164238: Toripalimab, Paclitaxel, Carboplatin, Cisplatin, 5-fu.

What condition does NCT04164238 study?

NCT04164238 studies Head and Neck Squamous Cell Carcinoma.

Is NCT04164238 still recruiting?

NCT04164238 is currently status unknown. Last updated 15 November 2019.

Last reviewed 2019-11-15 · How we verify

NCT04164238

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

Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients

Status unknown Phase 2 Last updated 15 November 2019

What this trial tests

Phase 2 trial testing Toripalimab in Head and Neck Squamous Cell Carcinoma in 90 participants. Status unknown.

Timeline

7 November 2019

Primary endpoint
7 November 2020

7 November 2021

Quick facts

Lead sponsor	First Affiliated Hospital of Zhejiang University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	7 November 2019
Primary completion	7 November 2020
Estimated completion	7 November 2021
Sites	1 location across China

Drugs / interventions tested

Toripalimab (TORIPALIMAB) — full drug profile →
Paclitaxel — full drug profile →
Carboplatin (Carboplatin) — full drug profile →
Cisplatin (cisplatin) — full drug profile →
5-fu

Conditions studied

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

Sponsor

First Affiliated Hospital of Zhejiang University

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Biotherapeutic Antibodies for the Treatment of Head and Neck Cancer: Current Approaches and Future Considerations of Photothermal Therapies.
Al Qaraghuli MM. · · 2020 · cited 10× · PMID 33324546 · DOI 10.3389/fonc.2020.559596

Verify or expand the search:

Other trials of Toripalimab

Trials testing the same drug.

NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07423078 — Window of Opportunity in Preserving Laryngeal Function Trial · Phase 2 · recruiting
NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
NCT07469956 — Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancre · Phase 2 · not yet recruiting

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 First Affiliated Hospital of Zhejiang University trials

Trials by the same sponsor.

NCT07537192 — Inulin-Spirulina Co-intervention for Insomnia Disorder · NA · not yet recruiting
NCT07510867 — 18F-FAPI PET/CT and MRI in Gastric Cancer · not yet recruiting
NCT07589647 — Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic D · NA · recruiting
NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
NCT07468162 — Characteristic Electroencephalogram of General Anesthesia · 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 NCT04164238 (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 First Affiliated Hospital of Zhejiang University
Last refreshed: 15 November 2019

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/NCT04164238.

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