Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma

Sponsor
Hospital of Stomatology, Wuhan University
Study ID
NCT05798793
Phase
PHASE3
Status
Recruiting
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Conditions

  • Oral Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab plus TP — DRUG
    The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
  • TP — DRUG
    The participants will receive docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.

Study Details

The purpose of this study is to investigate the survival benefit of neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy compared with TP chemotherapy or up-front surgery in resectable locally advanced oral squamous cell carcinoma.

Key Dates

Start date
Nov 21, 2023
Status verified
Apr 2024
Primary completion
Jul 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
309 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Surgery followed by postoperative RT
    The participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
  • Experimental: Neoadjuvant TP chemotherapy
    The participants will receive 2 courses of TP chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
  • Experimental: Neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy
    The participants will receive 3 doses of PD-1 blockade and 2 courses of TP chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.

Primary Outcome Measure

Event-free Survival (EFS) Rate on Each Treatment Arm. [ Time Frame: 24 months. ]

Central Contacts

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