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

NCT05125055 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

  • Oral Squamous Cell Carcinoma
  • Neoadjvant Therapy
  • Anti-PD-1
  • Chemotherapy

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.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-09-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125055 on ClinicalTrials.gov