Cervical squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
Conditions
Interventions
study group:Socazolimab
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. all the observed patients have signed the informed consent of the experimental treatment. Informed consent must be obtained at the time of implementation of the research requirements Sign before specifying the study procedure. On the day of signing the informed consent; 2. age >= 18 years old, female. 3. the ECoG physical fitness score was 0-2. 4. expected survival time >= 3 months. 5. cervical cancer confirmed by histology or cytology. 6. the pathological type was squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma; 7. without systemic anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy). Note: pelvic lymph node or paraaortic lymph node resection or biopsy for clinical staging is allowed. 8. locally advanced cervical cancer figo2018 Ib2-IIb, ? -Iva (whether lymph node positive or negative). 9. the diagnosis of lymph node metastasis can be confirmed by biopsy or imaging diagnosis,Imaging diagnosis of lymph node metastasis should meet the following requirements Standard MRI or CT showed positive lymph nodes (minimum transverse diameter >= 10mm). It should be noted that the minimum transverse diameter >= 15mm can be used as the target lesion. 18F-FDG PET/CT showed positive lymph nodes SUVmax >= 2.5). 10. there is at least one measurable tumor lesion according to RECIST v1.1 standard. 11. Female patients of childbearing potential must have a serum pregnancy test within 7 days before the first dose, and the result must be negative. If a female patient of childbearing potential has sexual intercourse with a non-sterilized male partner, she must use an acceptable and effective method of contraception from the start of screening and agree to continue using these protective measures until 120 days after the last dose of the study drug and at least 180 days after radiotherapy and chemotherapy; periodic abstinence and the rhythm method are not acceptable forms of contraception. 12. Highly effective contraceptive methods refer to those with a very low failure rate when used consistently and correctly (such as less than 1% per year). Not all contraceptive methods are highly effective. In addition to barrier methods, women of reproductive age can also use hormonal contraceptives (such as birth control pills) or intrauterine devices to ensure pregnancy does not occur. 13. Women of childbearing potential refer to women who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or who have not reached menopause (menopause is defined as at least 12 consecutive months of amenorrhea without medical cause, with serum follicle-stimulating hormone levels within the laboratory reference range for postmenopausal women).
Exclusion criteria
Exclusion criteria: 1. Has anatomical abnormalities or tumor geometry-related contraindications that prevent the use of brachytherapy. 2. Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or any therapy targeting immune co-stimulatory factors (such as antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.) or any other treatment targeting tumor immune mechanisms. 3. Patients who need systemic treatment with glucocorticoids (10 mg/day of prednisone or an equivalent dose of glucocorticoids) or other immunosuppressive drugs within 2 weeks prior to enrollment; exceptions include: inhaled, ophthalmic, or topical treatment with a dose 1000 IU/mL, and patients with active hepatitis C virus (HCV) infection. Note: inactive or asymptomatic carriers, and HBV patients who are treated and stable with HBV DNA <=1000 IU/mL, are allowed to be enrolled. Patients cured of HCV, HCV antibody positive and HCV RNA negative, are allowed to be enrolled. 12. Individuals with active or a history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), or active diverticulitis. 13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 14. Known history of severe hypersensitivity reactions to other monoclonal antibodies. 15. Women who are pregnant or breastfeeding. 16. Researchers believe that any condition that may pose a risk in receiving the study medication, or could interfere with the evaluation of the study drug, patient safety, or the analysis of study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression free survival;median overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of 2-year PFS and OS;rate of 5-year PFS and OS;rate of 1-year PFS and OS; | — |
Countries
China
Contacts
Public ContactCheng Shuxia
Henan Cancer Hospital
Outcome results
None listed