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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

NCT07007364 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-27

No results posted yet for this study

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

Conditions

  • Early-Stage Oral Squamous Cell Carcinoma

Interventions

DRUG

Adebrelimab 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

Sponsors & Collaborators

  • Jun Jia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2026-06-01
Completion
2027-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07007364 on ClinicalTrials.gov