RecruitingPhase 2NCT05862168

Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial

Neoadjuvant Tislelizumab Combined With Albumin-paclitaxel, Cisplatin, and Fluorouracil in Patients With Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective,Phase II Study


Sponsor

Weijia Fang, MD

Enrollment

30 participants

Start Date

May 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced HNSCC. These explorations have also achieved good results. Therefore, this study aims to explore the pathological remission rate, the long-term benefit and safety of Tislelizumab combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests tislelizumab (an immunotherapy drug) combined with chemotherapy given before surgery (neoadjuvant treatment) for people with locally advanced oral cancer (squamous cell carcinoma of the mouth). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with locally advanced oral squamous cell carcinoma (stage III or IVb) - You have not yet received any systemic treatment (chemotherapy, immunotherapy, or targeted therapy) for this cancer - You have at least one measurable tumor - You are in good general health (ECOG 0–1) with adequate organ function **You may NOT be eligible if...** - You have had another cancer that was not fully cured more than 5 years ago - You have a history of active bleeding or clotting disorders - You have active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding 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

DRUGTislelizumab

The participants will receive 3 cycles of Tislelizumab, with 21 days each. 200mg of Tislelizumab will be used intravenously on the first day of each cycle.

DRUGAlbumin paclitaxel

The participants will receive 3 cycles of Albumin paclitaxel, with 21 days each. 200mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.

DRUGCisplatin

The participants will receive 3 cycles of Cisplatin, with 21 days each. 20mg/m\^2 of Cisplatin will be used intravenously on days 1 through 3 of each cycle.

DRUG5-Fluorouracil

The participants will receive 3 cycles of 5-Fluorouracil, with 21 days each. 600mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.


Locations(1)

First affiliated hospital, School of Medicine, Zhejiang University

Hangzhou, China

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NCT05862168


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