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NCT06957938
Comparing Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor Versus Neoadjuvant Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Carcinoma
Phase 3 trial testing Neoadjuvant Chemotherapy (NACT) in Laryngeal Carcinoma in 168 participants. Not yet recruiting.
1 May 2029
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 168 |
| Start date | 28 April 2025 |
| Primary completion | 1 May 2029 |
| Estimated completion | 1 May 2031 |
| Sites | 1 location across China |
Drugs / interventions tested
- Neoadjuvant Chemotherapy (NACT) — full drug profile →
- Neoadjuvant and maintenance Tislelizumab — full drug profile →
- Concurrent chemo-radiotherapy (CCRT)
- Surgery and adjuvant (chemo-)radiotherapy
Conditions studied
- Laryngeal Carcinoma — all drugs for Laryngeal Carcinoma →
- Hypopharyngeal Carcinoma — all drugs for Hypopharyngeal Carcinoma →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Laryngeal Carcinoma or Hypopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Neoadjuvant chemotherapy combined with immunotherapy has achieved promising pathological remission rates in locally advanced head and neck squamous cell carcinoma and has offered new hope for patients with locally advanced laryngeal and hypopharyngeal cancer. In our center's previous phase II study on locally advanced laryngeal and hypopharyngeal cancer, neoadjuvant chemotherapy combined with immunotherapy showed good 1 - year laryngeal preservation rate and 1 - year PFS rate. However, in locally advanced laryngeal and hypopharyngeal cancer, whether neoadjuvant chemotherapy combined with PD-1 inhibitor, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival, event - free survival and overall survival remains unclear. Thus, this study aims to explore in locally advanced laryngeal and hypopharyngeal cancer whether neoadjuvant immuno - chemotherapy, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival and bring benefits in quality of life.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06957938
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Neoadjuvant Chemotherapy (NACT)
Trials testing the same drug.
- NCT06916117 — Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in LACC · Phase 2 · not yet recruiting
- NCT07054086 — Patient Derived Organoids (PDOs) to Observe the Clinical Consistency of Personalized Neoadjuvant Therapy for Resectable · recruiting
- NCT06714084 — CNCMT：a Multi-center, Prospective, Single-arm Study · NA · enrolling by invitation
Other recruiting trials for Laryngeal Carcinoma
Currently open trials in the same condition.
- NCT06940505 — Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Comparing Care Close to Home Versus Sta · NA · recruiting
- NCT06080503 — Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy · NA · recruiting
- NCT06463756 — AI Models to Predict Thyroid Cartilage Invasion in Laryngeal Carcinoma · recruiting
- NCT05075980 — Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study · Phase 2 · active not recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · 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)
- Trial protocol + status: ClinicalTrials.gov NCT06957938 (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 Fudan University
- Last refreshed: 8 May 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/NCT06957938.
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