Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer

Sponsor
Fujian Cancer Hospital
Study ID
NCT06455072
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Nituzumab — DRUG
    EGFR monoclonal antibody
  • Serplulimab — DRUG
    PD-1 (programmed death receptor 1) monoclonal antibody

Study Details

In recurrent advanced cervical cancer, patients were prone to drug resistance who have relapsed within prior platinum-based chemotherapy. However, immune checkpoint inhibitor's combination therapy has become a promising strategy for advanced cervical cancer. Epidermal Growth Factor Receptor (EGFR) is overexpressed in cervical cancer cells. Stereotactic radiotherapy (SBRT) can enhance the efficacy of immunotherapy.

Key Dates

Start date
Feb 1, 2023
Status verified
Jun 2024
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

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

Arms

  • Experimental: Nituzumab Plus Serplulimab Combined With SBRT
    Nituzumab was given intravenously (400mg qw, 21 days per cycle), and Serplulimab was administered intravenously (200mg once every 3 weeks).The dose was 30-50 Gy in three to five fractions and the number of lesions was no more than four by SBRT. The treatment was continued until disease progression, death or intolerant toxicity.

Primary Outcome Measure

ORR [ Time Frame: 2years ]

Central Contacts

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