A Prospective Single-Arm Study（NCLDR）

NCT07028918 | Not Yet Recruiting Early Phase 1

• 1 other identifier: KYLL-202502-008-1
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Squamous Cell Carcinoma (OSCC)

Keywords

Phase III, IVA, and IVB

Outcome Measures

Primary Outcomes (1)

• 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

  Surgery completed based on pathological results，9-10 week

Secondary Outcomes (1)

• Failure to achieve pathological remission rate (pCR)

  2 year

Study Arms (1)

OSCC（III、IVA、IVB）

EXPERIMENTAL

Patients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging)

Radiation: Low dose radiotherapy regimen; Drug: New adjuvant immunotherapy regimen; Procedure: Surgical treatment; Drug: Postoperative adjuvant therapy plan; Radiation: Radical radiotherapy plan

Interventions

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.

OSCC（III、IVA、IVB）

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).

OSCC（III、IVA、IVB）

Surgical treatment PROCEDURE

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.

OSCC（III、IVA、IVB）

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.

OSCC（III、IVA、IVB）

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.

OSCC（III、IVA、IVB）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Clinical Stage: Stage III, IVA, or IVB according to AJCC clinical staging.
• Absence of Distant Metastasis: No evidence of distant metastasis confirmed by auxiliary examinations.
• Prior Anti-tumor Therapy: No previous surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments.
• Measurable Lesion: At least one measurable target lesion according to RECIST 1.1 criteria, confirmed by imaging during the screening period.
• Adequate Organ Function: Meeting the following criteria:
• Hematology: White blood cell count (WBC) ≥ 4.0 x 10⁹/L; Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L; Hemoglobin (Hb) ≥ 90 g/L; Platelets (PLT) ≥ 100 x 10⁹/L.
• Liver Function: ALT and AST \< 3 x Upper Limit of Normal (ULN); Total bilirubin \< 1.5 x ULN; Child-Pugh class A or B; Normal liver tissue volume ≥ 700 cm³.
• Renal Function: Serum creatinine \< 1.5 x ULN.
• Coagulation: International Normalized Ratio (INR) and Activated Partial ·Thromboplastin Time (APTT) ≤ 1.5 x ULN.
• Serum Albumin: ≥ 28 g/L.
• Urinalysis: Urine protein \< 2+ (If baseline urine protein ≥ 2+, a 24-hour urine protein quantification must be performed within 7 days; enrollment requires quantification \< 1g).

You may not qualify if:

• 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.
• Bleeding Tendency/Disorder: Definite bleeding tendency or clinically significant bleeding symptoms within 28 days, including but not limited to gastrointestinal bleeding, epistaxis (excluding minor nosebleeds and blood-tinged sputum), or ongoing hemorrhagic or coagulopathic disease.
• Systemic Corticosteroids: Requirement for systemic corticosteroid therapy (\>10 mg/day prednisone or equivalent dose) or replacement therapy (\>10 mg/day prednisone equivalent) within 14 days prior to study treatment.
• Recent Procedures: Live vaccination within 4 weeks prior to study treatment or planned during the study period. Major surgery within 4 weeks prior to study treatment.
• Pregnancy/Lactation: Pregnant or breastfeeding women.
• Infectious Disease:
• Known immunodeficiency.
• Known history of Human Immunodeficiency Virus (HIV) or Acquired --·Immunodeficiency Syndrome (AIDS)-defining illness.
• Hepatitis B Virus (HBV) infection (HBsAg positive) or Hepatitis C Virus (HCV) ·infection (HCV RNA positive if anti-HCV antibody screening is positive).
• Known active history of Tuberculosis (TB).

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Acidemia, isovaleric

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Chen Qilu Hospital of shandong university, PhD

CONTACT

86+18560083733; 397475023@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 19, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share