Actively Recruiting
Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer
Led by Fujian Cancer Hospital · Updated on 2024-06-12
37
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
F
Fujian Cancer Hospital
Lead Sponsor
Z
Zhangzhou Municipal Hospital of Fujian Province
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Female gender
- Histologically or cytologically confirmed cervical squamous cell carcinoma with disease progression not responding to curative treatment
- Disease progression or recurrence within six months after at least one cycle of standard systemic treatment
- Not suitable for curative surgery or radiotherapy
- At least four weeks since completion of prior systemic therapy with resolved adverse events to grade 1 or less (except hair loss and fatigue)
- At least one measurable target lesion per RECIST V1.1
- At least one non-target lesion suitable for stereotactic radiotherapy (SBRT)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Expected survival time longer than 12 weeks
- Female participants capable of reproduction must use effective contraception during the study and for five months after last dose
- Consent to provide tumor tissue samples for EGFR expression testing or agree to tumor biopsy if no archived sample available
- Good organ and bone marrow function
You will not qualify if you...
- Diagnosis of malignancies other than cervical squamous cell carcinoma within 5 years, except certain treated skin and thyroid cancers
- Symptomatic pleural, pericardial, or ascitic effusions requiring drainage or not resolving quickly
- Prior or planned organ or bone marrow transplantation
- Active hepatitis B or C infection not controlled to specified viral load levels
- Meningeal or symptomatic central nervous system metastases; certain treated brain metastases allowed under conditions
- Life-threatening bleeding events within past 3 months
- Recent arterial thrombosis, embolism, or ischemia within past 6 months or significant thromboembolic events within 3 months
- Hepatic vein or major vessel thrombus
- Tumor invading critical organs or blood vessels with risk of fistula formation
- Uncontrolled high blood pressure or severe heart conditions
- Severe bleeding disorders or current thrombolytic therapy
- Recent gastrointestinal perforation, fistula, obstruction, or inflammatory bowel disease
- History of pneumonitis or active pneumonitis
- Active tuberculosis treatment within past year
- HIV infection or active syphilis
- Severe or uncontrolled infections
- Recent therapeutic antibiotic use
- Active or recent systemic autoimmune diseases requiring treatment
- Recent use of immunosuppressive drugs (except certain corticosteroids)
- Recent live attenuated vaccine or immune stimulation therapy
- Recent major surgery or unhealed wounds
- Uncontrolled metabolic, systemic, or non-malignant organ diseases
- Any other conditions increasing risk or interfering with study as judged by investigator
- Prior treatment with nintedanib, other anti-EGFR therapy, sunitinib, or anti-CTLA-4 antibody
- Allergies to study drugs or related monoclonal antibodies
- Receipt of anti-cancer treatment within 4 weeks before study start (with some washout exceptions)
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350011
Actively Recruiting
Research Team
Q
Qin Xu
CONTACT
L
Li Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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