Recurrent and metastatic cervical cancer patients who have not received systematic treatment in the past
Conditions
Interventions
Treatment Group:Combination of vediximab, sintilimab, platinum and SBRT
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The subjects voluntarily joined this study and signed a written informed consent form, and were able to comply with the visit and related procedures specified in the protocol. 2) Women aged >= 18 and = 24 weeks. 9) The completion of previous systemic treatment must be at least 4 weeks after the first use of medication in this study, and the treatment-related adverse events must have recovered to the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 = 1.5 × 10^ 9/L; Platelet count (PLT) >= 100 × 10^ 9/L; Hemoglobin (HGB) content >= 9 g/dL. Liver function (without albumin infusion within 14 days prior to obtaining results and with indications for liver protection treatment): Total bilirubin (TBIL) = 28 g/L. Renal function: serum creatinine (Cr) = 50mL/min (Cockcroft Gault formula); Patients whose urine routine results show urinary protein= 2+are required to undergo 24-hour urine collection with a 24-hour urine protein quantification of<1g. Coagulation function: International Normalized Ratio (INR) <= 2, and Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1) Diagnosed with other malignant tumors within 5 years prior to the first administration, excluding curative basal cell carcinoma, squamous cell carcinoma, excised carcinoma in situ, and/or papillary thyroid carcinoma. 2) Patients with clinical symptoms or requiring drainage of pleural effusion, ascites, and pericardial effusion (those who do not require drainage of effusion or have no significant increase in effusion within 3 days of stopping drainage can be selected). 3) Patients who are preparing for or have previously undergone organ or bone marrow transplantation. 4) Individuals infected with acute or chronic active hepatitis B or C, with hepatitis B virus (HBV) DNA>200IU/ml or 1000 copies/ml; Hepatitis C Virus (HCV) antibody positive and HCV-RNA level above the detection limit. Individuals infected with acute or chronic active hepatitis B or C who have undergone nucleotide antiviral therapy and meet the above criteria or laboratory test limits may be selected. 5)Any life-threatening bleeding events have occurred within the past 3 months. 6)Has experienced any arterial thrombosis, embolism or ischemia within the past 6 months, such as myocardial infarction, unstable angina, cerebrovascular accident, etc. There is a history of severe deep vein thrombosis or any other serious thromboembolism within the past 3 months prior to enrollment. 7) Portal vein cancer thrombus simultaneously affects the main stem and left and right branches of the portal vein, or simultaneously affects the main stem and superior mesenteric vein, inferior vena cava cancer thrombus; Superior vena cava cancer thrombus and superior vena cava syndrome. 8) Tumors invade important surrounding organs or blood vessels (such as mediastinal vessels, superior vena cava, inferior vena cava, abdominal aorta, iliac vessels, trachea, esophagus, etc.), or there is a risk of developing esophagotracheal fistula or esophageal pleural fistula. 9) Uncontrollable hypertension, with systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100mmHg after optimal medical treatment, and a history of hypertensive crisis or hypertensive encephalopathy. 10) Symptomatic congestive heart failure (New York Heart Association classification II-IV). Symptomatic or poorly controlled arrhythmia. QT interval prolongation, QTcF>470ms. 11)Severe bleeding tendency or coagulation dysfunction. 12) History of extensive intestinal resection, Crohn's disease, and ulcerative colitis. 13)History of interstitial pneumonia, drug-induced pneumonia, radiation pneumonia, idiopathic pneumonia, or active pneumonia. 14) Individuals with active pulmonary tuberculosis (TB) who are currently receiving anti tuberculosis treatment or have received anti tuberculosis treatment within one year prior to their first study medication. 15) Human Immunodeficiency Virus (HIV) infected individuals (HIV 1/2 antibody positive), known active syphilis infected individuals. 16) Severe infections that are active or poorly controlled clinically. Within 4 weeks prior to the first administration, there was a severe infection, including but not limited to hospitalization due to infection, bacteremia, or complications of severe pneumonia. 17) Administer therapeutic antibiotics orally or intravenously within one week before starting the study treatment. 18) An active autoimmune disease requiring systematic treatment or a medical history of the disease within the past two years (vitiligo, psoriasis, alopecia or Grave's disease requi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DOR;TTR;AE;TEAE;DCR;TTP;OS;SAE; | — |
Countries
China
Contacts
Public ContactQin Xu
Fujian Cancer Hospital
Outcome results
None listed