Nituzumab Plus Serplulimab Combined With SBRT in Recurrent Advanced Cervical Cancer: A Prospective, Multicenter, Single-arm, Phase II Clinical Trial
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.
• 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 treatments such as curative surgery or radiotherapy. 6) A minimum interval of four weeks must occur between the completion of prior systemic therapy and administration of the investigational drug. Additionally, any treatment-related adverse events must have resolved to CTCAE V5.0 grade ≤1 (excluding hair loss and fatigue).
• 7\) At least one measurable lesion must serve as a target lesion according to RECIST V1.1 criteria.
• 8\) Presence of at least one non-target lesion amenable to SBRT is also necessary.
• 9\) Eastern Cooperative Oncology Group Performance Status (ECOG PS) score should be either 0 or 1.
• 10）Expected survival time should exceed 12 weeks 11）Female subjects capable of reproduction need to utilize effective contraception throughout the study period and for at least five months following their final dose of the investigational drug 12）Subjects are required to consent providing sufficient tumor tissue samples for EGFR expression detection including archived tumor samples (paraffin blocks or an adequate number of unstained slides meeting study requirements); if no archived tumor tissue samples are available, subjects must agree on biopsy from the tumor site 13）Good organ function and bone marrow hematopoietic function.