A Prospective Single-Arm Study（NCLDR） (NCT07028918) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Prospective Single-Arm Study（NCLDR）
35 participantsStarted 2025-08-30
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete pathological response rate
Timeframe: Surgery completed based on pathological results，9-10 week
. Measurable Lesion: At least one measurable target lesion according to RECIST 1.1 criteria, confirmed by imaging during the screening period.
Exclusion criteria
. 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.