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A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC

NCT04992559 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-04-14

No results posted yet for this study

Summary

This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).

Conditions

  • Head and Neck Squamous Cell Carcinomas

Interventions

DRUG

Consolidation Toripalimab

Toripalimab consolidation therapy after radiotherapy or chemoradiotherapy, 240mg IV, every 3 weeks, until progressive disease (PD), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Toripalimab will be given at a maximum of 12 months.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2024-12-01
Completion
2027-05-01

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 NCT04992559 on ClinicalTrials.gov