Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/M HNSCC

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ID
NCT05156970
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab 200 mg IV on Day 1 of each 3-week cycle for up to 24 months
  • Cisplatin — DRUG
    Cisplatin 75 mg/m\^2 or Carboplatin AUC5 IV on Day 1 of each 3-week cycle (4 to 6 cycle maximum)
  • Docetaxel — DRUG
    Docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle (4 to 6 cycle maximum)
  • Apatinib Mesylate — DRUG
    Apatinib 250mg qd for up to 24 months
  • Carboplatin — DRUG
    Carboplatin at a target AUC 5 IV on Day 1 of each 3-week cycle (6 cycle maximum)

Study Details

This study is the first clinical study of first-line treatment of head and neck squamous cell carcinoma with drugs targeting VEGF signaling pathway combined with PD-1 inhibitors in China, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

Key Dates

Start date
Jun 24, 2021
Status verified
Jul 2025
Primary completion
Jun 24, 2024
Completion
Jun 24, 2025

Study Design

Enrollment
81 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab + Chemotherapy
    Participants receive Camrelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months;plus cisplatin 75 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle (6 cycle maximum).
  • Experimental: Camrelizumab +Apatinib mesylate
    Participants receive Camrelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months;plus Apatinib 250mg qd for up to 24 months.

Primary Outcome Measure

Overall Survival (OS) in All Participants [ Time Frame: 12 months ]

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