cervical cancer
Conditions
Sponsors
Pingdingshan First People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged >= 18 years; 2. Weight>30 kg; 3. ECOG performance status of 0-1; 4. Histologically proven cervical adenocarcinoma, cervical squamous cell carcinoma, or cervical adenosquamous carcinoma (? Stage B and above locally advanced cervical cancer); 5. No prior definitive surgery, radiotherapy or systemic treatment for cervical cancer has been performed, and no immunotherapy has been performed; 6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline; 7. Expected survival >=12 weeks; 8. The investigator evaluated suitability to receive CCRT; 9. Full organ and bone marrow function, i.e. meet the following criteria: Hemoglobin >= 9.0 g/dL;The neutrophil count was >=1.5 x 10^9/L;Platelet count >= 100 x 10^9/L;Total bilirubin = 60mL/min; 10. For women who are pre-menopausal or who have not undergone surgical sterilization: consent to abstinence from sex or use of effective contraceptive methods during the treatment period and for at least 4 months after the last dosing in the study treatment; 11. Voluntarily participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer; 2. Intent to administer a fertility-sparing treatment regimen; 3. Evidence of metastatic disease per RECIST 1.1 including lymph nodes >= 15 mm (short axis) above the L1 cephalad body, in the inguinal region or outside the planned radiation field; 4. Patients who have previously undergone hysterectomy (including subtotal hysterectomy) or will undergo hysterectomy as part of their initial cervical cancer treatment plan; 5. Have a history of allogeneic organ transplantation; 6. Active or previously recorded autoimmune or inflammatory diseases (including but not limited to inflammatory bowel disease [such as colitis or Crohns disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome [granulomatous polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this standard: patients with vitiligo or hair loss; patients with hypothyroidism (such as after Hashimoto's syndrome) and stable disease after receiving hormone replacement therapy; patients with any chronic skin disease that does not require systemic treatment; the past 5 Patients with no active disease in the first year can be included in the study after discussion with the study doctor; patients with celiac disease who rely solely on diet control; 7. Uncontrolled comorbidities, including but not limited to: persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes, uncontrolled arrhythmia, active interstitial ILD, a severe chronic gastrointestinal disease accompanied by diarrhea, or a mental illness/social problem that may limit compliance with research requirements, cause a significant increase in the risk of AEs, or affect the subjects ability to provide written informed consent; 8. History of other primary malignancies, except for the following: cured malignancies, and no known active disease >= 5 years before the first administration of IP, and the potential risk of recurrence is low; adequate treatment of non-melanoma skin cancer Or malignant moles, without signs of disease; Carcinoma in situ, fully treated, without signs of disease; 9. A history of active primary immunodeficiency; 10. Active infections include HBV HIV HCV; 11. With brain metastases or spinal cord compression, patients with suspected brain metastases at screening should undergo brain MRI (preferred) or CT (IV contrast agent is best used in the scan) before being enrolled in the study, and brain metastases at baseline will not be recorded as RECIST target lesions; 12. The mean QT interval for heart rate correction >= 470 ms based on the results of 3 ECG tests (within 15 min, at 5 min intervals) according to Fridericia formula (QTCF); 13. Known to produce allergic or hypersensitivity reactions to any study drug or any excipient thereof; 14. Patients who, in the investigator's judgment, are unlikely to comply with the study procedures, restrictions, and requirements shall not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactJing Xiaohui
Pingdingshan First People's Hospital
Outcome results
None listed