A Prospective Single-Arm Study（NCLDR）

ConditionOral Squamous Cell Carcinoma (OSCC)

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-70

SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 to 70 years old (inclusive) at the time of enrollment, based on the Gregorian calendar birth date. Age calculation is based on the date of signing the informed consent form. Includes both males and females.

ECOG Performance Status: 0-1.

Life Expectancy: ≥ 6 months.

Diagnosis: Histologically confirmed oral squamous cell carcinoma.

Disqualifiers

Unsuitable for Treatment: Unsuitable for receiving the protocol-specified low-dose radiotherapy, immunotherapy, and chemotherapy.

Prior Anti-tumor Therapy: Previous treatment with anti-tumor therapy, including investigational drugs, chemotherapy, radiotherapy, or prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies/drugs, or any other antibody/drug specifically targeting T-cell co-stimulatory checkpoint pathways.

Active Infection: Severe active infection requiring systemic therapy.

Cardiovascular/Cerebrovascular Events: History within 6 months prior to study treatment of: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.

Trial design

Design model

Single group

Treatments tested in this trial

Low dose radiotherapy regimen
Radiation
On the first and second day of chemotherapy and immunotherapy, low-dose radiotherapy of 1 Gy/1f was administered to the primary tumor lesion and metastatic lymph nodes, respectively, for a total of 4 Gy/4f.
New adjuvant immunotherapy regimen
Drug
Terriptylimab: fixed dose 240 mg, q30000, intravenous infusion, each infusion lasting 30 minutes (not less than 20 minutes, not more than 60 minutes); Chemotherapy regimen: Albumin bound paclitaxel: 175-260 mg/m2, d1, q3w; Platinum class: Cisplatin: 75mg/m2, d1-3, q3w; Carboplatin: AUC=5, d1, q3w (for patients with cisplatin allergy, intolerance, hearing impairment, creatinine clearance rate\<50ml/min, or grade 1 neuropathy that are not suitable for cisplatin use).
Surgical treatment
Procedure/Surgery
Surgery begins around 4 weeks after the first day of the second cycle of neoadjuvant therapy. The surgical plan is developed and evaluated by oral surgeons with years of clinical surgical experience. The determination of surgical margins is mainly based on baseline standards before neoadjuvant therapy for tumors, and can be appropriately reduced by oral surgeons depending on the situation.
Postoperative adjuvant therapy plan
Drug
* Patients with postoperative pathological progression of pCR were given maintenance treatment with Triprolizumab Q3W for 1 year. * Patients with postoperative pathology not reaching pCR should receive adjuvant radiotherapy (60-66Gy/30-33f) ③ Patients with high-risk recurrence factors in postoperative pathology (positive tumor margin or insufficient safe margin, presence of lymph node extracellular invasion) are given adjuvant radiotherapy and chemotherapy.
Radical radiotherapy plan
Radiation
① Radical radiotherapy for the primary lesion and cervical lymphatic drainage area. ② Synchronous cisplatin during radiotherapy: 75mg/m2, d1-3, q3w.

Treatment groups

35 Participants

are divided into 1 treatment group

Group A: OSCC（III、IVA、IVB）Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

Complete pathological response rate

Complete pathological response rate (pCR) of low-dose radiotherapy combined with chemotherapy and immune neoadjuvant therapy for locally advanced oral squamous cell carcinoma patients

Time frame

Surgery completed based on pathological results，9-10 week

Secondary outcomes

Failure to achieve pathological remission rate (pCR)

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

Time frame

2 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov

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