NCT06848439

Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer

Not yet recruiting Phase 2 Last updated 31 May 2025

What this trial tests

Phase 2 trial testing benmelstobart-Anlotinib-Chemo in Mouth Neoplasms in 26 participants. Not yet recruiting.

Timeline

15 June 2025

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	Jiangsu Cancer Institute & Hospital
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	15 June 2025
Primary completion	31 December 2027
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

• benmelstobart-Anlotinib-Chemo — full drug profile →

Conditions studied

• Mouth Neoplasms — all drugs for Mouth Neoplasms →
• Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →
• Immunotherapy — all drugs for Immunotherapy →
• Molecular Targeted Therapy — all drugs for Molecular Targeted Therapy →

Sponsor

Jiangsu Cancer Institute & Hospital

Who can join

Adults 18 to 75, any sex, with Mouth Neoplasms or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer

This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:

Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy/5 weeks.

Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy/5 weeks.

Group C (Partial Pathological Response/No Pathological Response):

Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.

High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.

Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Benmelstobart+anlotinib: an emerging therapeutic option in the targeted-immunotherapy era.
   Cheng P, Gu H, Chen Q, Zhao G, et al · · 2026 · PMID 42052493 · DOI 10.3389/fonc.2026.1748214
2. [Application of neoadjuvant immunotherapy in head and neck squamous cell carcinoma: From mechanisms to clinical practice].
   Chen J, Zhang J, Kuang Y, Chen Y, et al · · 2025 · PMID 42032983 · DOI 10.11817/j.issn.1672-7347.2025.250271