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Toripalimab in Combined With Cetuximab，Chemotherapy for Conversion Therapy of Locally Nonresectable OCSCC

NCT06081582 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-10-13

No results posted yet for this study

Summary

This is a prospective, single center phase II clinical study with a planned enrollment of 33 patients. The main objective is to evaluate the efficacy and safety of the PD-1 inhibitor toripalimab combined with cetuximab, cisplatin, and 5-FU regimen in the treatment of locally advanced oral squamous cell carcinoma patients who are initially unresectable.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Toripalimab

This study was conducted on 30 patients with initially unresectable locally advanced head and neck squamous cell carcinoma who underwent two cycles of PD-1 antibody (trepril monoclonal antibody) combined with fluorouracil, cisplatin, and cetuximab conversion therapy. The feasibility of radical surgery should be evaluated before surgical treatment.Three patients were enrolled in the safe induction period before the study began. The dosage of medication used is as follows: Toripalimab: 240mg, Day1, Q3W Cisplatin: 25mg/m2, Day1-3, Q3W（every 3 weeks） 5-FU: 1000mg/m2, Day1-3, Q3W Cetuximab Day 1, 8, 15, Q3W, 400 mg/m2 initial dose; Afterwards, 250 mg/m2 per week

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Yulong Zheng, MD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2024-03-31
Completion
2024-11-30

Countries

  • China

Study Locations

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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 NCT06081582 on ClinicalTrials.gov