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NCT07371234
Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Phase 2 trial testing Neoadjuvant and Adjuvant Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma in 22 participants. Currently enrolling.
15 January 2027
Quick facts
| Lead sponsor | Xiwei XU |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 15 December 2025 |
| Primary completion | 15 January 2027 |
| Estimated completion | 30 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Neoadjuvant and Adjuvant Immunotherapy — full drug profile →
- Low-dose radiotherapy
- Surgery
- Adjuvant Radiotherapy
- Adjuvant Cisplatin — full drug profile →
Conditions studied
- Locally Advanced Head and Neck Squamous Cell Carcinoma — all drugs for Locally Advanced Head and Neck Squamous Cell Carcinoma →
Sponsor
Xiwei XU — full company profile →
Who can join
Adults 18 to 75, any sex, with Locally Advanced Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Over 60% of head and neck squamous cell carcinoma (HNSCC) patients are diagnosed at a locally advanced stage. While standard treatments involve surgery and chemoradiotherapy, prognosis remains poor, with 50-60% experiencing local recurrence within two years. Neoadjuvant therapy can potentially reduce tumor burden, preserve organs, and lower distant metastasis risk. Despite the KEYNOTE-689 trial showing that adjuvant two-cycle pembrolizumab increased major pathological response to 9.8% in stage III-IVB HNSCC, this result remains insufficient. More effective immunotherapy-based combinations are urgently needed to improve long-term survival after neoadjuvant treatment. Preclinical and clinical evidence indicates that low-dose radiotherapy can activate the tumor immune microenvironment and synergize with immunotherapy. Based on this rationale, the present clinical trial will evaluate a neoadjuvant regimen combining LDRT with two cycles of an anti-PD-1 inhibitor in patients with surgically resectable, locally advanced HNSCC.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07371234
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Neoadjuvant and Adjuvant Immunotherapy
Trials testing the same drug.
- NCT07524452 — Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, · Phase 3 · recruiting
Other recruiting trials for Locally Advanced Head and Neck Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT07524452 — Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, · Phase 3 · recruiting
- NCT07369882 — Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Adva · NA · recruiting
- NCT06470217 — Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT06240689 — A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy f · Phase 2 · recruiting
- NCT06129864 — A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell C · Phase 3 · 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 NCT07371234 (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 Xiwei XU
- Last refreshed: 3 February 2026
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/NCT07371234.
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