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NCT06130007: B2023-153
A Prospective, Single-arm Phase II Clinical Trial of Tislelizumab Combined With Platinum Doublet Neoadjuvant Therapy to Improve Mandibular Preservation in Resectable Locally Advanced Oral Squamous Cell Carcinoma.
Phase 2 trial testing Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy in Oral Squamous Cell Carcinoma in 48 participants. Status unknown.
25 September 2024
Quick facts
| Lead sponsor | Xuekui Liu |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 25 November 2023 |
| Primary completion | 25 September 2024 |
| Estimated completion | 25 October 2024 |
Drugs / interventions tested
- Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy
Conditions studied
- Oral Squamous Cell Carcinoma — all drugs for Oral Squamous Cell Carcinoma →
Sponsor
Xuekui Liu
Who can join
Adults 18 to 70, any sex, with Oral Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Given the feasibility of induction chemotherapy in oral cancer and the encouraging remission rates achieved, we explore the clinical application prospects of using tislelizumab in combination with traditional standard chemotherapy as induction treatment in oral cancer patients who have no radiological evidence of mandibular erosion but require mandibulectomy due to the tumor's proximity to the mandible, aiming to shrink tumor size and increase the rate of mandible preservation. Therefore, we propose to conduct a prospective, single-arm, single-center phase II exploratory clinical trial: we plan to select patients with locally advanced resectable primary oral squamous cell carcinoma T3-4N0-3M0 (stages III-IVb, excluding T1-2) after multidisciplinary consultation and assessment by imaging and clinical evaluation. We aim to explore the feasibility of a three-week treatment regimen combining tislelizumab with polyaletin paclitaxel and a platinum-based triplet, preliminarily assess its clinical efficacy, adverse reactions, and postoperative mandible preservation rate, to provide the best comprehensive treatment plan for the preservation rate of the mandible in oral squamous cell carcinoma.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Head and neck cancer: pathogenesis and targeted therapy.
Liu Y, Zhang N, Wen Y, Wen J. · · 2024 · cited 21× · PMID 39170944 · DOI 10.1002/mco2.702 -
PD-1 inhibitor combined with paclitaxel and cisplatin in the treatment of recurrent and metastatic hypopharyngeal/laryngeal squamous cell carcinoma: efficacy and survival outcomes.
Fang Q, Li X, Xu P, Cao F, et al · · 2024 · cited 5× · PMID 38827739 · DOI 10.3389/fimmu.2024.1353435 -
The emerging role of neoadjuvant immunotherapy in locally advanced oral squamous cell carcinoma: progress and challenges.
Zhao TC, Dai YB, Zhou ZH, Huang YY, et al · · 2026 · PMID 41532448 · DOI 10.1097/js9.0000000000004783
Verify or expand the search:
- PubMed search for NCT06130007
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Xuekui Liu trials
Trials by the same sponsor.
- NCT06107114 — Cetuximab+Zimberelimab in Combination With Cisplatin and Nab-paclitaxel in Resctable Head and Neck Squamous Cell Carcino · Phase 2 · unknown
- NCT06023875 — Neoadjuvant Cadonilimab in Combination With Cisplatin and Nab-paclitaxel in Resectable Head and Neck Squamous Cell Carci · Phase 2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06130007 (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 Xuekui Liu
- Last refreshed: 13 November 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/NCT06130007.
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