Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma

Sponsor
Hospital of Stomatology, Wuhan University
Study ID
NCT04649476
Phase
PHASE2
Status
Completed

Conditions

  • Oral Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
  • Camrelizumanb plus TPF — 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, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.

Study Details

The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.

Key Dates

Start date
Mar 22, 2021
Status verified
Nov 2024
Primary completion
Aug 10, 2022
Completion
Aug 10, 2024

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant PD-1 blockade alone
    The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
  • Experimental: Neoadjuvant PD-1 blockade plus TPF induction chemotherapy
    The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.

Primary Outcome Measure

Pathologic Response. [ Time Frame: 8 weeks. ]

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