RecruitingPhase 2NCT07007364

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

Sponsor

Jun Jia

Enrollment

30 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

Early-Stage Oral Squamous Cell Carcinoma

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for early-stage oral cancer: low-dose radiation therapy given before surgery, along with an immunotherapy drug (adebrelimab) and a chemotherapy drug (albumin-bound paclitaxel). The goal is to see if this approach can shrink tumors and improve surgical outcomes. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed early-stage oral squamous cell carcinoma (stage I or II, specifically T1-2N0M0) - Your cancer is in the mouth (tongue, floor of mouth, gums, cheek, hard palate, or back molar area) - Your overall health is good (ECOG 0–1) - Your blood counts, liver, kidney, and heart function meet required levels **You may NOT be eligible if...** - Your oral cancer is more advanced (stage III or higher) - You have poor organ function that prevents you from tolerating the treatment - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab Combined With Albumin Paclitaxel

Eligible patients received neoadjuvant low-dose radiotherapy combined with Adebrelimab 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

Locations(1)

Hospital of Stomatology, Wuhan University

Wuhan, Hubei, China

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NCT07007364