RecruitingPhase 2NCT05098119

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

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


Sponsor

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

Enrollment

43 participants

Start Date

Sep 16, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (sintilimab) to a shorter course of chemotherapy before surgery can help treat mouth or throat cancer. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the mouth or throat (confirmed by biopsy) - You are between 18 and 80 years old - You are in good general health (able to carry out daily activities) - You have not previously received immunotherapy drugs like anti-PD-1 or anti-CTLA-4 treatments - Your blood counts and organ function (liver, kidneys) meet required levels - You are willing to use contraception if you could become pregnant or father a child **You may NOT be eligible if...** - You have had another cancer within the last 5 years - You have an active autoimmune disease requiring steroids - You have active HIV, Hepatitis B or C, or tuberculosis - You are currently pregnant or breastfeeding - You have active lung disease (like pneumonitis) - You are currently taking high-dose steroids or immune-suppressing medications 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

DRUGSintilimab, Nab-paclitaxel, Carboplatin

Neoadjuvant Therapy

PROCEDURESurgical resection

Standard of care

DRUGSintilimab

Adjuvant Therapy


Locations(1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

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NCT05098119


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