Locally advanced cervical cancer
Conditions
Interventions
Experimental group:Camrelizumab combined with concurrent radiotherapy and chemotherapy
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced cervical cancer diagnosed by pathology or clinical diagnosis, International Federation of Obstetrics and Gynecology (FIGO) 2014 IB2-IIB (lymph node positive) or FIGO 2014 III-IVA. 2. Have not received surgery, radiotherapy, system therapy, immunotherapy in the past. 3. With measurable tumor lesions (spiral CT scan >= 10mm, meet RECIST 1.1 standard). 4. Expected survival time > 3 months. 5. Age: 18 to 70 years old, no gender limit. 6. ECOG PS: 0-2 points. 7. The damage caused by the subject receiving other treatments has recovered. 8. The functions of vital organs meet the following requirements: a) Absolute neutrophil count >= 1.5*10^9/L, platelet >= 100*10^9/L, hemoglobin >= 9g/dL, b) Bilirubin 35g/ml, prothrombin time extension 60 mL/min. 9. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraception during treatment and 6 months after the last treatment dose. 10. The patient voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have previously undergone hysterectomy. 2. Unable to pass intracavitary brachytherapy or interstitial brachytherapy due to anatomy, tumor shape, and contraindications. 3. Suffer from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ. 4. Patients with bone marrow suppression or coagulation disorders and patients with renal impairment. 5. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated. Patients with a history of active tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment. 6. Patients with active hepatitis B or C, and chronically infected patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 2000 IU/mL are allowed to participate in the study, but are required during the study period Continue or start the full course of standardized antiviral therapy. 7. Subjects suffering from active, known or suspected autoimmune diseases, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected. 8. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months. 9. Patients receiving hematopoietic stem cell or organ transplantation. 10. Live vaccine has been vaccinated or will be vaccinated within 30 days before the administration of Camrelizumab. 11. Pregnant or lactating women. 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up. 13. Has a history of psychotropic drug abuse, alcohol or drug abuse. 14. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive. 15. The researcher thinks it is inappropriate to participate in this experiment.
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 ContactYunyan Zhang
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed