Cervical Cancer
Conditions
Interventions
Experimental group:Sindilizumab combined with chemotherapy
Sponsors
Hu'nan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Understand the research procedure and content, and voluntarily sign written informed consent; 2.Female, Aged 18 to 75 years; 3.Untreated stage IVB or recurrent or persistent cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosamous cell carcinoma) confirmed by histopathology are not suitable for surgery and/or radiotherapy; If there was a recurrence in the radiotherapy field and the target lesion satisfying RECIST 1.1 was in the radiotherapy field, it must be more than 3 months after the end of radiotherapy before inclusion; 4.According to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), at least one lesion can be measured on imaging; 5.ECOG PS score was 0-1; 6.With adequate organ and bone marrow function, the laboratory tests performed by screening must meet the following criteria: (1)Hemoglobin content >9g/dL in the case of that patients have no blood transfusion or use of erythropoietin during the last 14 days; (2)Absolute Neutrophil Count (ANC) >=1.5x10^9/L in the case of that patients have not use granulocyte colony stimulating factor during the last 14 days; (3)Platelet count >=90x10^9/L in the case of that patients have no blood transfusion during the last 14 days; (4)Total bilirubin =50 mL /min; (7)Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 x ULN; (8)Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is beyond the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can be included; (9)Myocardial enzyme spectrum was within the normal range (only laboratory abnormalities with no clinical significance were allowed to be included if comprehensively judged by the researcher); 7.Life expectancy of at least 3 months; 8.For female subjects of reproductive age, a urine or serum pregnancy test should be negative and should be performed within 3 days prior to the first study drug administration (cycle 1 day 1). If a urine pregnancy test cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age were defined as those more than one year after menopauseor having undergone sterilization operation or hysterectomy; 9.If there is a risk of pregnancy, all subjects will be required to use a contraceptive with an annual failure rate of less than 1% throughout the treatment period up to 120 days after the last study drug is administered.
Exclusion criteria
Exclusion criteria: 1.Other malignant tumors were diagnosed within 5 years prior to the first dose, with the exception of radical cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ; 2.Currently participating in interventional clinical research or treatment, or receiving other research drugs or using research equipment within 4 weeks before the first dose; 3.Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137); 4.Received systemic systemic therapy with anti-tumor indications of Proprietary Chinese medicines or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first administration; 5.An active autoimmune disease requiring systemic therapy (e.g., palliative drugs, glucocorticoids, or immunosuppressants) occurred within 2 years prior to initial dosing. Alternative therapies (e.g. thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary dysfunction) are not considered systemic; 6.The study was receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoid) or any other form of immunosuppressive therapy within 7 days prior to initial dosing; Note: Physiological doses of glucocorticoids are permitted (<=10 mg/ day of prednisone or equivalent); Physiological doses of corticosteroids (<=10 mg/day of prednisone or equivalent) are permitted; 7.Has undergone or planed to undergo major surgery within 4 weeks prior to the administration of the first study drug (except for surgery for biopsy purposes); Major surgery in this study was defined as a recovery time of at least 3 weeks after surgery. 8.Clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need drainage or have no significant increase in effusion after 3 days of cessation of drainage can be enrolled); 9.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10.Known to be allergic to the active ingredient or excipients of Sintilimab; 11.Has not fully recovered from toxicity and/or complications from any intervention before starting treatment (i.e., recover means grade <=1 or reached baseline, excluding fatigue or hair loss); 12.Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 13.Untreated active hepatitis B (defined as HBsAg positive with hbV-DNA copy number greater than the upper limit of the normal value in the laboratory department of the research center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: With HBV viral load <1000 copies/mL (200 IU/ml) prior to initial administration, subjects should receive anti-HBV therapy throughout the study to avoid viral reactivation Prophylactic anti-HBV therapy is not required for HBc (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), but HCV-infected subjects with active virus reactivation should be closely monitored (HCV antibody positive and HCV-RNA levels above the detection limit); 14.Vaccination of live vaccine within 30 days before the first dose (1st cycle, 1st day); Note: Inactivated virus vaccines for seasonal influenza, injectable drugs are permitted; however, live attenuated influenza vaccines are not allowed for intranasal admi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Duration of response;Disease Control Rate;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactRan Xiaomin
Hu'nan Cancer Hospital
Outcome results
None listed