NCT07137858

Adebrelimab Combined With Carboplatin and Albumin-bound Taxanol in the Treatment of Resectable Locally Advanced Oral Squamous Cell Carcinoma Cardiac, Randomized, Phase II Exploratory Study

Not yet recruiting Phase 2 Last updated 22 August 2025

What this trial tests

Phase 2 trial testing Preoperative neoadjuvant immunotherapy chemotherapy in Oral Squamous Cell Carcinoma (OSCC) in 70 participants. Not yet recruiting.

Timeline

15 August 2025

Primary endpoint
30 June 2027

31 December 2027

Quick facts

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	15 August 2025
Primary completion	30 June 2027
Estimated completion	31 December 2027

Drugs / interventions tested

• Preoperative neoadjuvant immunotherapy chemotherapy — full drug profile →
• Two courses of preoperative neoadjuvant immunotherapy chemotherapy — full drug profile →
• Three courses of preoperative neoadjuvant immunotherapy chemotherapy — full drug profile →

Conditions studied

• Oral Squamous Cell Carcinoma (OSCC) — all drugs for Oral Squamous Cell Carcinoma (OSCC) →
• Neoadjuvant Chemoimmunotherapy — all drugs for Neoadjuvant Chemoimmunotherapy →

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Adults 18 to 75, any sex, with Oral Squamous Cell Carcinoma (OSCC) or Neoadjuvant Chemoimmunotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Programmed death ligand-1 (PD-L1) plays a role in inhibiting the cancer-immune cycle by binding to negative regulatory factors of T cell activation such as PD-1 and B7.1. It has achieved good therapeutic effects in lung cancer, liver cancer and other cancers. Previous studies have shown that three cycles of PD-L1 inhibitors combined with chemotherapy have satisfactory efficacy and safety in locally advanced oral squamous cell carcinoma. However, during the three-cycle treatment process, due to the accumulation of drug toxicity, patients' tolerance to adverse reactions decreases, increasing the risk of serious adverse events and psychological pressure on patients. Based on this, this study aims to explore the efficacy of two cycles of avelumab (PD-L1 inhibitor) combined with chemotherapy in locally advanced oral squamous cell carcinoma, to explore whether it can achieve the same efficacy as three cycles while shortening the treatment time, reduce the risk of serious adverse events, and further verify the efficacy and safety of PD-L1 inhibitors combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma. This study uses the postoperative pathological complete response (PCR) rate as the primary outcome indicator, and the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival (EFS) rate, and 2-year and 5-year overall survival (OS) rate as secondary outcome indicators to evaluate the efficacy and long-term survival impact.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.