cervix cancer
Conditions
Interventions
experimental group:Camrelizumab,Paclitaxel,Carboplatin,concurrent chemoradiotherapy
Sponsors
Lu'an People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years (inclusive, calculated as of the date of signing the informed consent form); Histologically or cytologically confirmed diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 2.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1; 3.Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, with at least one measurable lesion. 4.Life expectancy exceeding 3 months; 5.Adequate function of major organs, defined as: (1) Hematological parameters (without blood transfusion, blood products, granulocyte colony-stimulating factor [G-CSF], or other hematopoietic stimulators within 14 days): a. Hemoglobin (Hb) =90 g/L;b. Absolute neutrophil count (ANC) >=1.5×10?/L; c. Platelet count (PLT) >=80×10?/L. (2) Biochemical parameters:a. Total bilirubin (TBIL) =60 mL/min (calculated by Cockcroft-Gault formula). 6.Non-sterilized women of childbearing potential must have negative pregnancy test results (serum or urine) within 7 days prior to enrollment, and agree to use highly effective contraception during the study period and for 8 weeks after the last administration of investigational drug.
Exclusion criteria
Exclusion criteria: 1. Abnormal coagulation (International Normalized Ratio (INR) of prothrombin time >1.5 or Prothrombin Time (PT) >ULN+4 seconds or APTT >1.5 ULN), bleeding tendency, or receiving thrombolytic or anticoagulant therapy; Note: Small doses of heparin (0.6 million to 12,000 U per day for adults) are permitted for prophylaxis, provided that the INR is =450ms in men and >=470ms in women); according to the NYHA standard, grade III-IV new insufficiency, or cardiac ultrasound suggests that the left ventricular ejection fraction (LVEF) is 10mmol/ml); 4. Pregnant and lactating women; 5. Allergy to drug components or excipients; 6. Prior or concurrent other malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast (DCIS), papillary thyroid carcinoma, and other malignancies adequately treated and cured for >=3 years prior to randomization with evidence of no recurrent metastasis; 7. Presence of any active or known autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, pituitary gland inflammation, hyperthyroidism, etc.). Type I diabetes mellitus treated with stabilized doses of insulin, hypothyroidism requiring only hormone replacement therapy, and skin diseases (e.g., eczema, vitiligo, or psoriasis) that do not require systemic therapy and have not acutely worsened in the 1 year prior to the Screening Period are permitted for enrollment; asthmatics requiring medical intervention with bronchodilators are not eligible for inclusion; 8. those who have received a previous organ transplant; 9. systemic treatment with corticosteroids (>10 mg/d of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to treatment; inhaled or topical corticosteroids in the absence of active autoimmune disease and adrenal hormone replacement therapy at doses of =10 mg/d of prednisone efficacy dose are allowed; 10.Patients with a history of psychotropic substance abuse that is not amenable to abstinence or with a neurologic or psychiatric disease or disorder that is not readily controllable, and who are unable to cooperate and narrate a response to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR);toxicological reaction;quality of life; | — |
Countries
China
Contacts
Public ContactFeng Rong
Lu'an People's Hospital
Outcome results
None listed