Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT07028918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Single-Arm Study（NCLDR）
Sponsor:
Qilu Hospital of Shandong University
Organization:
Study Overview
Official Title:
Phase II Trial of Neoadjuvant Chemoimmunotherapy With Low-Dose Radiotherapy in Locally Advanced Oral Squamous Cell Carcinoma: A Prospective Single-Arm Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NCLDR
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: