Clinical trial · Interventional
A Prospective Single-Arm Study(NCLDR)
Phase II Trial of Neoadjuvant Chemoimmunotherapy With Low-Dose Radiotherapy in Locally Advanced Oral Squamous Cell Carcinoma: A Prospective Single-Arm Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Squamous Cell Carcinoma (OSCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose radiotherapy regimen | Radiation | — | UNRESOLVED |
| New adjuvant immunotherapy regimen | Drug | — | UNRESOLVED |
| Postoperative adjuvant therapy plan | Drug | — | UNRESOLVED |
| Radical radiotherapy plan | Radiation | — | UNRESOLVED |
| Surgical treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OSCC(III、IVA、IVB)
- description
- Patients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging)
- interventionNames
- Radiation: Low dose radiotherapy regimen
- Drug: New adjuvant immunotherapy regimen
- Procedure: Surgical treatment
- Drug: Postoperative adjuvant therapy plan
- Radiation: Radical radiotherapy plan
Primary outcomes (1)
- measure
- Complete pathological response rate
- timeFrame
- Surgery completed based on pathological results,9-10 week
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
【Inclusion Criteria】: 1. 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. 2. ECOG Performance Status: 0-1. 3. Life Expectancy: ≥ 6 months. 4. Diagnosis: Histologically confirmed oral squamous cell carcinoma. 5. Clinical Stage: Stage III, IVA, or IVB according to AJCC clinical staging. 6. Absence of Distant Metastasis: No evidence of distant metastasis confirmed by auxiliary examinations. 7. Prior Anti-tumor Therapy: No previous surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments. 8. Measurable Lesion: At least one measurable target lesion according to RECIST 1.1 criteria, confirmed by imaging during the screening period. 9. 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). * Electrocardiogram (ECG): No significant abnormalities. * Cardiac Function: Left Ventricular Ejection Fraction (LVEF) ≥ 50%. 10. Contraception: Women of childbearing potential must have reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment. They must be willing to use adequate contraception during the trial and for 8 weeks after the last dose of the study drug. Men must agree to use adequate contraception or be surgically sterilized during the trial and for 8 weeks after the last dose of the study drug. 11. Informed Consent: Ability to understand and voluntarily sign the informed consent form (signed by a legal representative if the participant loses capacity), with expected good compliance. 【Exclusion Criteria】: 1. Unsuitable for Treatment: Unsuitable for receiving the protocol-specified low-dose radiotherapy, immunotherapy, and chemotherapy. 2. 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. 3. Active Infection: Severe active infection requiring systemic therapy. 4. 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. 5. 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. 6. 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. 7. 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. 8. Pregnancy/Lactation: Pregnant or breastfeeding women. 9. 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). 10. Other Exclusionary Conditions: Any other factor identified by the investigator that may lead to premature termination of the study, such as severe laboratory abnormalities, or concomitant familial or social factors that could compromise participant safety or affect data/sample collection.
References
Publications (0)
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