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RECRUITING
NCT05098119
PHASE2

Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002)

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

View on ClinicalTrials.gov

Summary

The study is being conducted to evaluate the efficacy and safety of sintilimab in combination with reduction of cycles of chemotherapy (carboplatin and nab-paclitaxel) in patients with oral cavity or oropharyngeal squamous cell carcinoma who are about to undergo surgery. Data obtained in this trial will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in oral cavity or oropharyngeal squamous cell carcinoma.

Official title: Phase II Trial of Sintilimab, an Anti-PD-1 Monoclonal Antibody, in Combination With Reduction of Cycles of Chemotherapy, as a Novel Neoadjuvant Pre-Surgical Therapy for Oral Cavity or Oropharyngeal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2021-09-16

Completion Date

2028-09-16

Last Updated

2024-03-26

Healthy Volunteers

No

Interventions

DRUG

Sintilimab, Nab-paclitaxel, Carboplatin

Neoadjuvant Therapy

PROCEDURE

Surgical resection

Standard of care

DRUG

Sintilimab

Adjuvant Therapy

Locations (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China