NCT06848439

Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer

A Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients With Locally Advanced Oral Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Mouth Neoplasms
• Neoadjuvant Therapy
• Immunotherapy
• Molecular Targeted Therapy

Interventions

Type	Name	Description
DRUG	benmelstobart-Anlotinib-Chemo	Neoadjuvant Treatment Regimen : Benmelstobart: 1200mg, Day 1, IV (21 days per cycle); Anlotinib: 10mg, Days 1-14, orally (21 days per cycle); Cisplatin: 60mg/m², Day 1, IV (21 days per cycle); Albumin-bound Paclitaxel: 260mg/m², IV infusion, Day 1 (21 days per cycle). Total of 3 cycles. Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading: Group A (pCR): Postoperative RT alone: 40Gy/5 weeks. Group B (MPR): Postoperative RT alone: 50Gy/5 weeks. Group C (partial pathological response/no pathological response) : low and intermediate-risk patients: RT: 60Gy/6w; High-risk patients: CCRT: 60-66Gy/6-6.6w + cisplatin: 60mg/m2 Q3W, 2-3 cycles. All patients also received adjuvant Benmelstobart 3-4 weeks after surgery, as well as maintenance Benmelstobart for a total duration of 1 year.

Timeline

• Start date: 2025-06-15
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-02-27
• Last updated: 2025-05-31

Locations

1 site across 1 country: China