Unresectable advanced cervical cancer with high risk factors
Conditions
Interventions
experimental group:Carrelizumab and GM-CSF combined with full dose chemoradiotherapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. This hospital is pathologically diagnosed as cervical malignant tumor, and it has been assessed by two or more senior doctors that it is not resectable; 2. Accompanied by high-risk factors; high-risk factors are defined as: gynaecological examination by senior physicians reveals parauterine infiltration, lesions larger than 4cm, lesions involving the lower 1/3 of the vagina, which meets one of them; imaging evaluation of pelvic lymph nodes positive, para-aortic Positive lymph node, distant metastasis, meet one of them; biopsy suggests invasion of rectal mucosa or bladder mucosa, meet one of them; 3. Have not received surgery, radiotherapy, systemic therapy, or immunotherapy in the past; 4. Complete baseline assessment of tumor lesions according to the RECIST 1.1 standard 28 days before the start of treatment: there is at least one measurable lesion, that is, according to CT cross-sectional images, PET-CT or MRI, the length of non-lymph node lesions is >= 10 mm, or the lymph node lesions are short Diameter >= 15 mm; 5. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 to 1; 6. Expected survival time> 3 months; 7. Participate voluntarily and sign an informed consent form, understand the possible progression and recurrence of the disease, and be willing to take risks; 8. Organ function and hematopoietic function must meet the following requirements: hemoglobin (HGB) >= 90 g/L; white blood cell count (WBC) >= 3x10^9/L; absolute neutrophil count (ANC) >= 1.5x10^ 9/L; platelet count (PLT) >= 100x10^9/L; total bilirubin (TBIL) = 50 mL /min International Normalized Ratio (INR) or Plasma Prothrombin Time (PT) <= 1.5xULN.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Have active autoimmune diseases and have received systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years; 3. Those who have received live vaccination within 4 weeks before the start of treatment; 4. Those with meningeal metastasis or symptomatic central nervous system metastasis; 5. Combined with autoimmune diseases, serious medical diseases, and other malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Toxic side effects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactRen Fang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed