Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07007364

Neoadjuvant Low-Dose Radiotherapy Combined With Adebrelimab and Single-Agent Albumin-Bound Paclitaxel Chemotherapy for Early-Stage Oral Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Trial

Led by Jun Jia · Updated on 2025-06-27

30

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, single-arm, Phase II clinical trial. The included population consisted of untreated patients with histologically confirmed stage I-II oral squamous cell carcinoma. Eligible patients received neoadjuvant low-dose radiotherapy combined with adibelizumab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy. The primary endpoints were the rate of pathological response and the rate of exemption from cervical lymph node dissection. The secondary endpoints included progression-free survival, local control rate, distant metastasis-free rate, overall survival, safety and quality of life of patients, as well as the exploration of biomarkers

CONDITIONS

Official Title

Neoadjuvant Low-Dose Radiotherapy Combined With Adebrelimab and Single-Agent Albumin-Bound Paclitaxel Chemotherapy for Early-Stage Oral Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Trial

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 70 years, any gender
  • Confirmed diagnosis of oral squamous cell carcinoma in the anterior 2/3 of the tongue, floor of the mouth, gingiva, buccal mucosa, hard palate, or posterior molar area
  • Diagnosed as stage I-II oral squamous cell carcinoma (T1-2N0M0) based on the 8th edition of the American Joint Committee on Cancer staging
  • ECOG performance status of 0 or 1
  • Normal vital organ function able to tolerate treatment, including:
    • Bone marrow: white blood cell count ≥3.5×10⁹/L, neutrophil count ≥2.0×10⁹/L, hemoglobin ≥100 g/L, platelet count ≥100×10⁹/L
    • Liver and kidney function within specified limits (total bilirubin ≤1.5× ULN; AST/ALT ≤2.5× ULN; alkaline phosphatase ≤2.5× ULN; creatinine clearance ≥60 mL/min)
    • Normal thyroid, coagulation, pituitary function, infection markers, myocardial enzymes, ECG, and echocardiography
  • Women of childbearing age (18-49 years) must have negative pregnancy tests within 7 days before treatment and agree to use approved contraception during and for 120 days after treatment
  • Signed informed consent and willingness to follow study procedures and visits
Not Eligible

You will not qualify if you...

  • Uncontrollable pleural, pericardial, or peritoneal effusions requiring repeated drainage
  • History of allergy to Adebrelimab
  • Received investigational drugs within 4 weeks before starting this treatment or within 5 half-lives of last investigational drug use
  • Currently enrolled in another interventional clinical trial
  • Received anti-tumor therapy (radiotherapy, chemotherapy, immunotherapy, endocrine, targeted, biological therapy, or tumor embolization) within 2 weeks before starting study drug
  • Need for corticosteroids >10 mg prednisone equivalent daily within 2 weeks before study drug start, except routine chemotherapy premedication
  • Received anti-tumor vaccines or live vaccines within 4 weeks before study drug start
  • Major surgery or severe trauma within 4 weeks before study drug start
  • Prior treatment with taxane drugs
  • Toxicities from previous cancer treatments not recovered to grade 1 or less (except alopecia)
  • Active autoimmune diseases or history of autoimmune diseases, except certain controlled conditions
  • History of immunodeficiency including HIV, organ or bone marrow transplantation, or active hepatitis exceeding specified viral load
  • Poorly controlled cardiovascular conditions including NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
  • Severe infections within 4 weeks before study drug start or active pulmonary inflammation requiring antibiotics
  • History of interstitial lung disease (except specified pneumonitis cases)
  • Active or untreated pulmonary tuberculosis or history of active pulmonary tuberculosis within 1 year
  • Diagnosis of any other malignant tumor within 5 years except adequately treated low-risk tumors
  • Pregnant or breastfeeding women
  • Other serious diseases or conditions judged by investigators to interfere with study participation or safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital of Stomatology, Wuhan University

Wuhan, Hubei, China

Actively Recruiting

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Research Team

J

JJia Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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