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NCT06895369
The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC
Phase 2 trial testing Pucotenlimab in Squamous Cell Carcinoma of Head and Neck in 30 participants. Not yet recruiting.
31 December 2028
Quick facts
| Lead sponsor | Sir Run Run Shaw Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 May 2025 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2033 |
| Sites | 1 location across China |
Drugs / interventions tested
- Pucotenlimab — full drug profile →
Conditions studied
- Squamous Cell Carcinoma of Head and Neck — all drugs for Squamous Cell Carcinoma of Head and Neck →
Sponsor
Sir Run Run Shaw Hospital
Who can join
Adults 18 to 70, any sex, with Squamous Cell Carcinoma of Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study Objective: To evaluate the efficacy and safety of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (HNSCC). Study Design: This is a single-arm interventional study. Intervention: Patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination. Endpoints: Pathological complete response rate (pCR) after surgery, major pathological response rate (MPR) of the treatment regimen, disease-free survival (DFS), and overall survival (OS). Hypothesis: The combination of pucotenlimab and TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced HNSCC is expected to improve pathological response rates and enhance patient prognosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06895369
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Related trials
Other trials of Pucotenlimab
Trials testing the same drug.
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- NCT07353827 — FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarc · Phase 2 · not yet recruiting
- NCT07394244 — Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma · Phase 2 · not yet recruiting
Other recruiting trials for Squamous Cell Carcinoma of Head and Neck
Currently open trials in the same condition.
- NCT07455032 — Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous · Phase 1 · recruiting
- NCT07219212 — A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck S · Phase 1 · recruiting
- NCT07276399 — A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurre · Phase 3 · recruiting
- NCT07063212 — A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC) · Phase 2 · recruiting
- NCT06487403 — HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune R · NA · recruiting
Other Sir Run Run Shaw Hospital trials
Trials by the same sponsor.
- NCT07453940 — Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Sympto · NA · recruiting
- NCT07508943 — Decision-making and Optimization of Ventilatory Support for AECOPD Patients · not yet recruiting
- NCT07514533 — The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma · Phase 2 · not yet recruiting
- NCT07350590 — Comparison Between Robotic and Laparoscopic Right Hemicolectomy · terminated
- NCT07457073 — AI-Powered Sound Analysis for COPD Screening · active not recruiting
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 NCT06895369 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sir Run Run Shaw Hospital
- Last refreshed: 26 March 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/NCT06895369.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing