A Prospective Single-Arm Study（NCLDR）

Early Phase 1

Not yet recruiting

• Conditions: Oral Squamous Cell Carcinoma (OSCC)
• Interventions: Radiation: Low dose radiotherapy regimen; Drug: New adjuvant immunotherapy regimen; Procedure: Surgical treatment; Drug: Postoperative adjuvant therapy plan; Radiation: Radical radiotherapy plan

• Registration Number: NCT07028918
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

To investigate the safety and efficacy of low-dose radiotherapy combined with chemotherapy and immunotherapy as neoadjuvant therapy for locally advanced oral squamous cell carcinoma (OSCC), and to explore whether low-dose radiotherapy can induce cross-presentation of tumor-specific antigens, enhance lymphocyte infiltration into the tumor microenvironment, and thereby amplify tumor-specific immune responses, ultimately improving the therapeutic outcomes of neoadjuvant chemoimmunotherapy.

Detailed Description

This study is a prospective, phase II clinical trial that enrolled patients with locally advanced oral squamous cell carcinoma (based on AJCC clinical staging, clinical stages III, IVA, and IVB). The patients were treated with a combination of albumin paclitaxel and cisplatin and trastuzumab for 2 cycles before surgery. On the day of the 2 chemotherapy immunotherapy sessions and the second day (d1, d2), the patients were given 1 Gy/1f of radiation therapy for the primary lesion and metastatic lymph nodes, for a total of 4 Gy/4f. Approximately 4 weeks after the first day of the second treatment cycle, evaluate the condition of the lesion and cervical lymph nodes. Patients can undergo surgical treatment after resection. After surgery, based on pathological results, decide on the postoperative adjuvant treatment plan: patients with postoperative pathological progression of pCR will receive maintenance treatment with Triprolizumab Q3W for 1 year, while patients without postoperative pathological progression of pCR will receive adjuvant radiotherapy (60-66Gy/30-33f). If there are high-risk recurrence factors (positive tumor margin or insufficient safe margin, lymph node extracellular invasion), adjuvant radiotherapy and chemotherapy will be given. Patients assessed as unresectable will receive curative radiotherapy and chemotherapy, and immune maintenance will be chosen based on the patient's specific condition after completion. Collect safety related indicators such as adverse reactions (AE) and surgical delay rate during and after treatment for patients; pCR、MPR、 Use treatment related indicators such as 2-year EFS rate, 2-year OS rate, and oral function retention rate to statistically analyze the effectiveness and safety of treatment plans.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-01
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Study Start: 2025-08-30
• Primary Completion: 2026-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OSCC（III、IVA、IVB）	Low dose radiotherapy regimen	Patients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging)
OSCC（III、IVA、IVB）	New adjuvant immunotherapy regimen	Patients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging)
OSCC（III、IVA、IVB）	Surgical treatment	Patients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging)
OSCC（III、IVA、IVB）	Postoperative adjuvant therapy plan	Patients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging)
OSCC（III、IVA、IVB）	Radical radiotherapy plan	Patients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging)

Primary Outcome Measures

Name	Time	Method
Complete pathological response rate	Surgery completed based on pathological results，9-10 week	Complete pathological response rate (pCR) of low-dose radiotherapy combined with chemotherapy and immune neoadjuvant therapy for locally advanced oral squamous cell carcinoma patients

Secondary Outcome Measures

Name	Time	Method
Failure to achieve pathological remission rate (pCR)	2 year	Secondary endpoints: The major pathological response (MPR) rate, objective response rate (ORR), oral function preservation rate, 2-year event-free survival (EFS) rate, 2-year overall survival (OS) rate, and safety profile of low-dose radiotherapy combine