Camrelizumab Plus Docetaxel and Cisplatin in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ID
NCT05611463
Phase
PHASE2
Status
Unknown

Conditions

  • Oral Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab Plus Docetaxel and Cisplatin — DRUG
    Camrelizumab (200 mg) was administered once on day 1 every 3 weeks until disease progression, intolerable toxicity, physician or participant decision or 35 cycles, whichever occurred first. Chemotherapy was received docetaxel (75 mg/m2) and cisplatin (75 mg/m²) on day 2 every 3 weeks for six cycles.

Study Details

the purpose of this study is to assess the efficacy and safety of camrelizumab plus Docetaxel and Cisplatin as First-line Therapy in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients

Key Dates

Start date
Jun 2, 2020
Status verified
Sep 2022
Primary completion
Dec 2, 2022
Completion
Jun 2, 2023

Study Design

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

Arms

  • Experimental: Camrelizumab Plus Docetaxel and Cisplatin
    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).

Primary Outcome Measure

Participants Experiencing an Adverse Event (AE) [ Time Frame: 24 months ]

Central Contacts

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