RecruitingPhase 2Phase 3NCT05125055

Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC

Neoadjuvant Toripalimab and Albumin Paclitaxel /Cisplatin Versus Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

80 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two neoadjuvant (pre-surgery) treatment combinations for locally advanced oral cavity squamous cell carcinoma (mouth cancer): standard chemotherapy (TPF — docetaxel, cisplatin, fluorouracil) versus a combination of an immunotherapy (anti-PD-1) plus two chemotherapy drugs (TP — cisplatin and paclitaxel). The goal is to shrink the tumor before surgery and improve the chances of complete removal. **You may be eligible if...** - You are 18–75 years old with a confirmed diagnosis of oral cavity squamous cell carcinoma (tongue, gums, cheek, floor of mouth, hard palate, or posterior molar area) - Your cancer is stage III or IVA (locally advanced but not yet spread to distant organs) - You have adequate blood counts, liver, kidney, and clotting function - Your general health allows chemotherapy and surgery (ECOG 0–2) **You may NOT be eligible if...** - You have already received treatment for this cancer - You have known allergy to study drugs - You have active autoimmune disease or are on chronic steroids - You have uncontrolled infections including HIV, Hepatitis B or C - 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

DRUGToripalimab (anti-programmed death-1 inhibitor)

The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.

DRUGAlbumin paclitaxel

The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.

DRUGCisplatin

The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m\^2 of Cisplatin will be used intravenously on the first day of each cycle.

DRUGDocetaxel

The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m\^2 of Docetaxel will be used intravenously on the first day of each cycle.

DRUG5-Fluorouracil

The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.


Locations(1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT05125055


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