Last reviewed · How we verify
NCT05831930
Radiotherapy Combined With Nitozumab and Sinilimab in the Treatment of Locally Advanced Unresectable Platinum Intolerant Head and Neck Squamous Cell Carcinoma： an Open-label Single-arm, Phase II Trial
EARLY_PHASE1 trial testing Nituozumab in HNSCC in 62 participants. Status unknown.
1 January 2026
Quick facts
| Lead sponsor | Sichuan Cancer Hospital and Research Institute |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 17 January 2023 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Nituozumab — full drug profile →
Conditions studied
- HNSCC — all drugs for HNSCC →
Sponsor
Sichuan Cancer Hospital and Research Institute
Who can join
18 and older, any sex, with HNSCC. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Complete remission rate
Time frame: 2 years
The rate of patient complete remission
Sponsor's own description
For patients with locally advanced head and neck tumors who are over 70 years old, have PS\>2, have hearing impairment, renal dysfunction, or have neuropathy greater than grade 1 that is intolerant to cisplatin, radiotherapy alone or combined with EGFR monoclonal antibody radiotherapy should be chosen. The purpose of this study is to demonstrate the superior efficacy of Nitozumab and Sinilimab when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05831930
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HNSCC
Currently open trials in the same condition.
- NCT07035249 — DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07081984 — Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors · Phase 1 · recruiting
- NCT07182149 — A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors · Phase 1 · recruiting
- NCT07106827 — A Study of GV20-0251 in Advanced or Refractory Solid Tumors · Phase 1 · recruiting
- NCT07136545 — A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metas · Phase 1, PHASE2 · recruiting
Other Sichuan Cancer Hospital and Research Institute trials
Trials by the same sponsor.
- NCT07269912 — Application of Multimodal MRI in Histological Grading and Prognostic Assessment of Rectal Cancer · not yet recruiting
- NCT07082699 — The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of · NA · not yet recruiting
- NCT06939764 — Application of the sG8 Scale in Real-World Geriatric Oncology Patients · not yet recruiting
- NCT06717854 — Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial · NA · not yet recruiting
- NCT06860685 — Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Cancer Surgery · Phase 1, PHASE2 · 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 NCT05831930 (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 Sichuan Cancer Hospital and Research Institute
- Last refreshed: 16 April 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/NCT05831930.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing