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Recruiting Phase 2 NCT06455072

Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer

Trial Parameters

Condition Cervical Cancer
Sponsor Fujian Cancer Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 37
Sex FEMALE
Min Age 18 Years
Max Age 75 Years
Start Date 2023-02-01
Completion 2025-01-31
Interventions
NituzumabSerplulimab

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 1\) Prospective participants will be voluntarily enrolled in this research study and will provide written informed consent, demonstrating the ability to adhere to scheduled visits and associated procedures. 2\) Individuals aged between 18 and 75 years old are eligible for inclusion. 3) Patients with histologically or cytologically confirmed cervical squamous cell carcinoma, along with documented disease progression that is unresponsive to curative treatment. It should be noted that confirmation of the original primary tumor tissue by a pathological report is required. 4\) Ineligibility due to failure of standard systemic treatment for persistent, recurrent, or metastatic cervical cancer (defined as progression or recurrence within six months after at least one cycle of standard systemic treatment; patients who have previously received anti-PD-1/PD-L1 antibody treatment and achieved CR, PR, or SD≥6 months may still be considered). 5\) Not suitable for local treatme

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