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Induction Chemotherapy and Toripalimab Followed by Radiotherapy in Unresectable Laryngeal/Hypopharyngeal Carcinoma

NCT05420597 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-06-15

No results posted yet for this study

Summary

The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.

Conditions

  • Laryngeal Cancer
  • Hypopharyngeal Cancer

Interventions

DRUG

Toripalimab

Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2，Cisplatin 25mg/m2 d2-4 q3w. Then a total dose of 70Gy in 35 fractions was administered, with concurrently weekly cisplatin (30mg/m2 qw). At 3-6 weeks post-radiotherapy, maintenance Toripalimab was administered for 8 cycles (240mg d1 q3w, in total 8 cycles).

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xiayun He, M.D. · Fudan University

  • Yu Wang, M.D. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2024-12-31
Completion
2025-12-31

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 NCT05420597 on ClinicalTrials.gov