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Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients

NCT04473716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-22

No results posted yet for this study

Summary

The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.

Conditions

  • Oral Cancer
  • Induction Chemotherapy
  • Programmed Cell Death 1 Inhibitor
  • Inductive Therapy

Interventions

DRUG

Toripalimab

Neoadjuvant therapy with Toripalimab of 240mg, iv, qd, on day 1, 22

DRUG

Paclitaxcel

Neoadjuvant therapy with Paclitaxcel of 260mg/m2, iv, qd, on day 1, 22

DRUG

Cisplatin

Neoadjuvant therapy with Cisplatin of 75mg/m2, iv, qd, on day 1, 22

PROCEDURE

Radical surgery

Radical surgery will be performed on the 43th-48th after initiation of inductive therapy.

RADIATION

Post-operative radiotherapy/chemoradiotherapy

Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathological diagnosis.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Lai-ping Zhong, MD, PhD · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2021-04-12
Completion
2023-09-30

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 NCT04473716 on ClinicalTrials.gov