Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients

Sponsor
Shanghai Jiao Tong University School of Medicine
Study ID
NCT05069857
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anti-PD-1
  • Anti-VEGFR
  • Neoadjvant Therapy
  • Oral Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab (anti-PD-1 inhibitor) — DRUG
    The patients will receive three cycles of Camrelizumab, with 14 days each. 200mg of Carrelizumab will be used intravenously on the first day of each cycle.
  • Apatinib (anti-VEGFR inhibitor) — DRUG
    The patients will receive Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle.

Study Details

To evaluate the efficacy of neoadjuvant anti-PD-1 plus anti-VEGFR therapy for patients with locally advanced and resectable oral squamous cell carcinoma, and the CPS\>10 in the biopsy samples.

Key Dates

Start date
Sep 1, 2021
Status verified
Nov 2023
Primary completion
Aug 30, 2024
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Neoadjuvant arm
    The patients received three cycles of neoadjuvant therapy, with 14 days each. Dosage and administration: 200mg Carrelizumab intravenously on the first day of each cycle; Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle. Then the patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.
  • No Intervention: Control arm
    The patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.

Primary Outcome Measure

2-year disease-free survival rate [ Time Frame: 24 months ]

Central Contacts

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