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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

September 30, 2024

Study Completion Date

December 30, 2026

Conditions
Oral Squamous Cell CarcinomaNeoadjvant TherapyAnti-PD-1Chemotherapy
Interventions
DRUG

Toripalimab (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.

DRUG

Albumin 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.

DRUG

Cisplatin

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.

DRUG

Docetaxel

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.

DRUG

5-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.

Trial Locations (1)

20011

RECRUITING

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

All Listed Sponsors
lead

Shanghai Jiao Tong University School of Medicine

OTHER