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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

Recruiting now Phase 2 Last updated 27 June 2025
What this trial tests

Phase 2 trial testing Adebrelimab Combined With Albumin Paclitaxel in Early-Stage Oral Squamous Cell Carcinoma in 30 participants. Currently enrolling.

Timeline
19 June 2025
Primary endpoint
1 June 2026
1 June 2027

Quick facts

Lead sponsorJun Jia
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date19 June 2025
Primary completion1 June 2026
Estimated completion1 June 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jun Jia — full company profile →

Who can join

Adults 18 to 70, any sex, with Early-Stage Oral Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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