Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma

Sponsor
Eye & ENT Hospital of Fudan University
Study ID
NCT04156698
Phase
PHASE2
Status
Unknown

Conditions

  • Chemotherapy
  • Hypopharyngeal Carcinoma
  • Immunotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Docetaxel is a chemotherapy drug.
  • Cisplatin — DRUG
    Cisplatin is a chemotherapy drug.
  • Capecitabine — DRUG
    Capecitabine is a chemotherapy drug.
  • Camrelizumab — DRUG
    Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Study Details

This is a single-center, multidisciplinary, open-label, single-arm prospective clinical study.

Key Dates

Start date
May 21, 2020
Status verified
Aug 2023
Primary completion
Apr 16, 2023
Completion
Jan 16, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab (PD-1 inhibitor) group
    Induction chemotherapy combined with immunotherapy (TPF + Camrelizumab), q3w, 3 cycles in total: Docetaxel (domestic) 75 mg/m2 i.v. d1, Cisplatin 25 mg/m2 i.v. d1-3, Capecitabine 800 mg/m2 po bid d1-d14, Camrelizumab 200mg i.v. d1; Radical radiotherapy plus concurrent immunotherapy (CR or PR): Radiotherapy: Using intensity-modulated radiation therapy (IMRT). Primary site: GTV dose 66 (2.2Gy / fraction)-70 Gy (2Gy / fraction)；CTV 1.6-1.9 Gy / fraction. Cervical lymph nodes: Radiotherapy plan is the same as the radiotherapy plan of original site; Concurrent immunotherapy : Camrelizumab 200mg i.v. d1, d22; Maintenance period: After completing concurrent chemoradiotherapy combined with immunotherapy, Camrelizumab 200 mg q3w will be given up to 12 months (calculated from the time of the first dose of PD-1 immunotherapy).

Primary Outcome Measure

Overall Response Rate [ Time Frame: 9 weeks ]

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