NCT05758389 is a Phase 2 clinical trial of Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU in Head and Neck Tumors, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.

What drugs are being tested in NCT05758389?

Interventions in NCT05758389: Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU.

What condition does NCT05758389 study?

NCT05758389 studies Head and Neck Tumors.

Is NCT05758389 still recruiting?

NCT05758389 is currently recruiting now. Last updated 5 September 2025.

Last reviewed 2025-09-05 · How we verify

NCT05758389

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

Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors

Recruiting now Phase 2 Last updated 5 September 2025

What this trial tests

Phase 2 trial testing Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU in Head and Neck Tumors in 29 participants. Currently enrolling.

Timeline

1 April 2022

Primary endpoint
7 August 2025

7 December 2025

Quick facts

Lead sponsor	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	1 April 2022
Primary completion	7 August 2025
Estimated completion	7 December 2025
Sites	1 location across China

Drugs / interventions tested

Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU — full drug profile →

Conditions studied

Head and Neck Tumors — all drugs for Head and Neck Tumors →

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Who can join

Adults 18 to 75, any sex, with Head and Neck Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are: 1. evaluate the efficacy and safety of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy in the treatment of locally advanced head and neck tumors. 2. the exploration of efficacy-related immune microenvironment genes Participants will receive tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy.

Publications & conference data

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

Taxanes in the Treatment of Head and Neck Squamous Cell Carcinoma.
Hsieh CY, Lin CC, Chang WC. · · 2023 · cited 8× · PMID 38001888 · DOI 10.3390/biomedicines11112887
Harnessing nucleotide metabolism and immunity in cancer: a tumour microenvironment perspective.
Suleiman H, Emerson A, Wilson PM, Mulligan KA, et al · · 2025 · cited 7× · PMID 39308084 · DOI 10.1111/febs.17278
Evaluation of neoadjuvant immunotherapy regimens for head and neck squamous cell carcinoma: a systematic review and single-arm and network meta-analysis.
Ye Z, Fan W, Zeng B, Tan R, et al · · 2026 · PMID 41504501 · DOI 10.1097/js9.0000000000004689

Verify or expand the search:

Other recruiting trials for Head and Neck Tumors

Currently open trials in the same condition.

NCT06479811 — [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, · Phase 1 · recruiting
NCT06968520 — Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis · recruiting
NCT06767488 — Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors · recruiting
NCT06791941 — Study of the Contribution of Mutant p53/YAP Proteins to Therapy Resistance in Recurrent Head and Neck Cancer · recruiting
NCT05671458 — Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherap · NA · recruiting

Other The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials

Trials by the same sponsor.

NCT06966765 — Accelerated vs Standard Approach to Continuous Veno-venous Hemodiafiltration Post-hemoperfusion (ASAP) in Severe Acute D · Phase 3 · not yet recruiting
NCT07403071 — Validating Fish Oil's Role in Alleviating Bortezomib-Induced Neuropathy: A Multi-Method Study Integrating Big Data, Expe · not yet recruiting
NCT07532538 — A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions · not yet recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07399574 — Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diqua · 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 NCT05758389 (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 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Last refreshed: 5 September 2025

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/NCT05758389.

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