Oral Squamous Cell Carcinoma (OSCC)Early Phase 1NCLDRNCT07028918
A Prospective Single-Arm Study(NCLDR)
A Early Phase 1 study testing Low dose radiotherapy regimen, New adjuvant immunotherapy regimen and Surgical treatment in people with Oral Squamous Cell Carcinoma (OSCC), run by Qilu Hospital of Shandong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Low dose radiotherapy regimen, New adjuvant immunotherapy regimen and Surgical treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 30 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
【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.
- 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).
- Electrocardiogram (ECG): No significant abnormalities.
- Cardiac Function: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- 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.
- 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】:
- 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).
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II Trial of Neoadjuvant Chemoimmunotherapy With Low-Dose Radiotherapy in Locally Advanced Oral Squamous Cell Carcinoma: A Prospective Single-Arm Study
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.
Read the 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.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Being tested
- Low dose radiotherapy regimen, New adjuvant immunotherapy regimen, Surgical treatment, Postoperative adjuvant therapy plan, Radical radiotherapy plan
- Keywords
- Phase III, IVA, and IVB
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Acidemia, isovaleric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose radiotherapy regimenRadiation
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 regimenDrug
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 treatmentProcedure or 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 planDrug
- 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 planRadiation
① Radical radiotherapy for the primary lesion and cervical lymphatic drainage area.
② Synchronous cisplatin during radiotherapy: 75mg/m2, d1-3, q3w.
| Study group | Role | What they receive |
|---|---|---|
| OSCC(III、IVA、IVB) | Experimental | Patients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging) Receives: Radiation: Low dose radiotherapy regimen; Drug: New adjuvant immunotherapy regimen; Procedure: Surgical treatment; Drug: Postoperative adjuvant therapy plan; Radiation: Radical radiotherapy plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Surgery completed based on pathological results,9-10 week
Secondary outcomes (1)
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
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028918
- Sponsor's protocol ID
- KYLL-202502-008-1
- Acronym
- NCLDR
- Status last verified
- May 2025
- First submitted
- 1 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Ethical restrictions prohibiting open data sharing per local IRB. 2. Inclusion of potentially identifiable biometric data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Neoadjuvant Chemoimmunotherapy With Low-Dose Radiotherapy in Locally Advanced Oral Squamous Cell Carcinoma: A Prospective Single-Arm Study
- ClinicalTrials.gov ID
- NCT07028918
- Acronym / sponsor ID
- NCLDR / KYLL-202502-008-1
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Keywords
- Phase III, IVA, and IVB
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSCC(III、IVA、IVB) | Experimental | Radiation: Low dose radiotherapy regimen, Drug: New adjuvant immunotherapy regimen, Procedure: Surgical treatment, Drug: Postoperative adjuvant therapy plan, Radiation: Radical radiotherapy planPatients with locally advanced oral squamous cell carcinoma (clinical stages III, IVA, and IVB according to AJCC clinical staging) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose radiotherapy regimenOn 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. | Radiation | OSCC(III、IVA、IVB) |
| New adjuvant immunotherapy regimenTerriptylimab: 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). | Drug | OSCC(III、IVA、IVB) |
| Surgical treatmentSurgery 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. | Procedure or surgery | OSCC(III、IVA、IVB) |
| Postoperative adjuvant therapy plan* 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. | Drug | OSCC(III、IVA、IVB) |
| Radical radiotherapy plan① Radical radiotherapy for the primary lesion and cervical lymphatic drainage area. ② Synchronous cisplatin during radiotherapy: 75mg/m2, d1-3, q3w. | Radiation | OSCC(III、IVA、IVB) |
Primary outcome
Complete pathological response rate
Time frame: Surgery completed based on pathological results,9-10 week
Complete pathological response rate (pCR) of low-dose radiotherapy combined with chemotherapy and immune neoadjuvant therapy for locally advanced oral squamous cell carcinoma patients
1 secondary outcome
Failure to achieve pathological remission rate (pCR)
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No. 1. Ethical restrictions prohibiting open data sharing per local IRB. 2. Inclusion of potentially identifiable biometric data.
Related trials for Oral Squamous Cell Carcinoma (OSCC)
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ImmunoADC Therapy for Induction Conversion in Patients With Stage IVB OSCC/OPSCC
Stage IVB Oral Cavity Squamous Cell Carcinoma, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
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Neck Observation or Elective Neck Dissection in cT1N0M0 OSCC
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Not yet recruitingPhase 3
Neoadjuvant Sintilimab Plus Chemotherapy for cT2N0M0 Oral Squamous Cell Carcinoma
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Not yet recruitingPhase 2
Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy for Oral or Oropharyngeal Squamous Cell Carcinoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low dose radiotherapy regimen, New adjuvant immunotherapy regimen and Surgical treatment in people with Oral Squamous Cell Carcinoma (OSCC), run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Qilu Hospital of shandong university, PhD (86+18560083733, 397475023@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pathological response rate (time frame: Surgery completed based on pathological results,9-10 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.