NCT04926753

Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized phase 1, open-labeled clinical study, 1-arm, single center, to observe efficacy and safety of chemotherapy plus PD-L1 antibody Toripalimab every 21 days for 2 cycles as induction regimen in locoregionally-advanced laryngo-hypopharyngeal squamous cell cancer patients.

Detailed description

Locoregionally advanced laryngo-hypopharyngeal squamous cell cancer patients have the demand of laryngo-preservation. Induction chemotherapy (FP) combined with Toripalimab (a humanized IgG4 monoclonal antibody against PD-1) will be given. This regimen will be given every 21 days for 2 cycles. Radiological examinations and PET(FDG/FAPI) examinations pre/post-treatment will be administrated for response evaluation.

Conditions

• Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer

Interventions

Type	Name	Description
DRUG	5-Fluorouracil, Cisplatin, Toripalimab	Drug: FP combined with Toripalimab Combination drugs: 5-Fluorouracil(F), Cisplatin/Carboplatin(P) and Toripalimab every 21 days for 2 cycles This is a single-arm study with all patients receiving these three drugs.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-12-01
• Completion: 2024-06-01
• First posted: 2021-06-15
• Last updated: 2021-06-16

Locations

1 site across 1 country: China