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Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer

NCT06848439 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-05-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Affiliated Stomatological Hospital of Nanjing Medical University

    collaborator UNKNOWN

  • Jiangsu Cancer Institute & Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06848439 on ClinicalTrials.gov