cervical cancer
Conditions
Sponsors
He'nan Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be able to sign informed consent, including complying with the requirements and restrictions set out in the Informed Consent (ICF) and this protocol; 2. Date and sign written informed consent prior to carrying out any required study specific procedures, sampling and analysis; 3. Provide signed and dated written informed consent for genetic studies prior to collection of genetic analysis samples; 4. Female aged >= 18 years at screening time, and whose weight > 30 kg; 5. Histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma, or cervical adenosquamous carcinoma and meeting the following requirements: GO IB2 to IIb, lymph node positivity (N>=1) - or -FIGO IIIa to IVA, any N (N>=0);Lymph node staging can be determined by surgery or imaging (RECIST v1.1);No evidence of metastatic disease (M0); 6. At least one lesion (>=4cm, no previous radiotherapy) meets RECIST 1.1 target lesion criteria at baseline. Tumor evaluation by CT scan or MRI must be performed within 28 days prior to randomization; 7. ECOG: 0 - 1; 8. The investigator assessed the suitability of receiving CCRT; 9. Expected survival >=12 weeks; 10. Full organ and bone marrow function, that is, meeting the following criteria: Hemoglobin >=9.0 g/dL, The neutrophil count was >=1.5x10^9/L, Plate count >=75x10^9/L, Clear bilirubin =60mL/min .
Exclusion criteria
Exclusion criteria: 1. Fertility preservation treatment plan is proposed; 2. According to RECIST 1.1, metastatic disease is identified, including lymph nodes >=15 mm (short axis) located above the first lumbar vertebra (L1) (cephalic) or outside the planned exposure field; 3. Patients who have undergone prior hysterectomy (including subtotal hysterectomy) or who will undergo hysterectomy as part of their initial treatment regimen for cervical cancer; 4. Have a history of allotransplantation; 5. Active or previously recorded autoimmune or inflammatory diseases (including but not limited to inflammatory bowel diseases [such as colitis or Crohn's disease], diverticulitis [other than diverticulitis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome [granulomatous polyangiitis, Graves' disease, rheumatoid arthritis, pituitaritis, grape)Membranitis, etc.]).Exceptions to this standard are: patients with vitiligo or hair loss; Patients with hypothyroidism (e.g., after Hashimoto syndrome) and stable condition after hormone replacement therapy; Patients with any chronic skin disease that does not require systematic treatment;Patients who have been free of active disease for the past 5 years may be included in the study after discussion with the study physician; Patients with celiac disease on diet alone; 6. Uncontrolled co-diseases, including but not limited to:Persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes, uncontrolled arrhythmias, active interstitial pulmonary disease (ILD), severe chronic gastrointestinal disease with diarrhea,Or psychiatric/social problem conditions that may limit compliance with study requirements, cause a significant increase in the risk of AE, or affect subjects' ability to provide written informed consent; 7. A history of other primary malignancies except: cured malignancies with no known active disease for >= 5 years prior to the first dose of IP and with a low potential risk of recurrence;Adequate treatment of non-melanoma skin cancer or malignant moles without signs of disease;Adequately treated carcinoma in situ without signs of disease; 8. A history of active primary immunodeficiency; 9. Active infections include tuberculosis (clinical assessment including clinical history, physical and imaging findings, and tuberculosis screening based on local practices), hepatitis B (known to be HBV positive for HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV, HIV 1/2 antibody positive).Patients with prior HBV infection or who have been cured of HBV infection (defined as the presence of hepatitis B core antibodies [anti-HBC] and the absence of HBsAg) are eligible.Patients with positive HCV antibodies may participate in this study only if they are negative for HCV RNA as indicated by polymerase chain reaction (PCR); 10. Brain metastasis or spinal cord compression. Patients with suspected BMs at the time of screening should undergo brain MRI (preferred) or CT (preferably with IV contrast) prior to enrolment in the study. Brain metastases were not recorded as RECIST target lesions at baseline; 11. The Fridericia formula (QTCF) was used to calculate the mean QT interval of heart rate correction >= 470 ms based on the results of 3 ECG tests (within 15 min, at 5 min intervals); 12. Known to produce allergic or hypersensitive reactions to any study drug or any excipient thereof; 13. Previous history of bladder, vaginal or rectal fistula;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two years' recurrence rate;Objective response rate;Disease control rate;Overall survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactCheng Huijun
He'nan Tumor Hospital
Outcome results
None listed