Cerivcal Cancer
Conditions
Interventions
Treatment group:Vedecitumumab + Sepalizumab +SBRT
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Participants voluntarily participated in the study, provided written informed consent, and were able to comply with the protocol-specified visit and related procedures. 2) Age =18 years old and =75 years old. 3) histologically confirmed cervical cancer with documented disease progression (disease not amenable to curative treatment).4) Recurrent, metastatic cervical cancer that failed prior platinum-based standard therapy, platinum-based concurrent chemoradiotherapy, or immunotherapy (patients who failed prior anti-PD-1 / PD-L1 antibody therapy were allowed). 5) Patients who are unable to be cured by radical surgery or regional radiotherapy.6) The interval between the end of previous systemic therapy and the first dose of the study drug must be at least 4 weeks and treatment-related aes returned to the Common Terminology Criteria for Adverse Events. CTCAE V5.0=1 (except alopecia and fatigue). 7) According to RECIST V1.1, there must be at least one measurable target lesion as the target lesion, and at least one lesion that can be treated by Stereotactic Body Radiotherapy (SBRT). 8) Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-2. 9) expected survival time =24 weeks. 10) Women of childbearing age, should use an effective contraceptive method throughout the treatment period and for at least 5 months after the last dose of study drug. 11) Subjects must agree to provide sufficient tumor tissue samples for testing of human epidermal growth factor receptor 2 (HER2) expression. Archival tumor samples (paraffin blocks or unstained sections in numbers that met the investigational testing requirements) were included. Participants consented to undergo rebiopsy of the tumor lesion if an archived tumor tissue sample was not available. HER2 expression was positive or higher. 12) Patients must have enough organ and bone marrow hematopoietic function, and laboratory tests within 7 days before enrollment meet the following requirements: A. Blood routine examination (no blood components and cell growth factors were given within 14 days before the results were obtained) : Absolute Neutrophil Count (ANC) =1.5×10 9/L; Platelet count (PLT) =100×10 9/L; Hemoglobin (HGB) level =9 g/dL. B. Liver function (drugs with indications for liver-protective therapy without albumin infusion within 14 days before the results were obtained) : serum Total Bilirubin (TBIL) =1.5× Upper Limit of Normal Value (ULN); Aalanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) =3×ULN; ALT and AST=5×ULN in subjects with liver metastasis; Serum albumin =28 g/L. C. Renal function: serum Creatinine (Cr) =1.5×ULN or creatinine clearance (CCr) =50mL/min (Cockcroft-Gault formula); Patients with urinary protein < 2+ on urinalysis or =2+ on urinalysis at baseline had 24-hour urine collection and 24-hour urinary protein quantification of < 1g. D. Coagulation function: International Normalized Ratio (INR) =2, and Activated Partial Thromboplastin Time (APTT) =1.5×ULN.
Exclusion criteria
Exclusion criteria: 1) Subjects were diagnosed other malignancies within 5 years, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, radical carcinoma in situ, and/or papillary thyroid carcinoma. 2) Patients with clinical symptoms or pleural effusion, ascites, or pericardial effusion requiring drainage (patients with no need for drainage or no significant increase in effusion within 3 days after cessation of drainage were eligible). 3) Candidates for or prior recipients of organ or bone marrow transplantation.4) Acute or chronic active Hepatitis B or hepatitis C infection, Hepatitis B virus (HBV) DNA > 200IU/ml or 1000 copies /ml; Hepatitis C Virus (HCV) antibody positive and HCV-RNA level higher than the lower limit of detection. Patients with acute or chronic active hepatitis B or hepatitis C who were below the above criteria or below the lower limit of laboratory detection after nucleotide antiviral therapy were eligible for inclusion. 5) leptomeningeal metastasis or symptomatic central nervous system (CNS) metastasis. Patients with asymptomatic brain metastases or stable symptoms for 2 weeks or more after treatment of brain metastases were eligible to participate in the study if they met all the following criteria: measurable disease outside the central nervous system; There was no metastasis to the meninges, midbrain, pons, cerebellum, medulla oblongata or spinal cord. No previous history of intracranial hemorrhage; Hormone therapy was discontinued 14 days before the first dose of study drug. 6) Any life-threatening bleeding event in the previous 3 months, including the need for blood transfusion, surgery or local treatment, and continued medical therapy.7) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, etc. in the past 6 months. A history of deep-vein thrombosis or any other major thromboembolism (thrombosis of implantable venous-access port or catheter origin, superficial venous thrombosis, or a thrombus that was stable with conventional treatment were not considered to be "major" thromboembolism) within 3 months before enrollment. 8) Portal vein tumor thrombus involving both the main portal vein and its left and right branches, or the main portal vein and superior mesenteric vein or inferior vena cava tumor thrombus simultaneously; Superior vena cava tumor thrombus, superior vena cava syndrome. 9) Tumor invasion of surrounding important organs or blood vessels (such as mediastinal vessels, superior vena cava, inferior vena cava, abdominal aorta, iliac vessels, trachea, esophagus, etc.), or the risk of esophagotracheal or esophagopleural fistula. 10) Uncontrolled hypertension, systolic blood pressure = 150mmHg or diastolic blood pressure =100mmHg with best medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 11) Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled arrhythmias. The QT interval was prolonged with QTcF > 470ms. 12) Severe bleeding tendency or coagulopathy, or receiving thrombolytic therapy.13) Subjects had a history of gastrointestinal perforation and/or fistula within the previous 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or wide bowel resection (partial colectomy or wide bowel resection with chronic diarrhea), Crohn's disease, ul
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;Overall survival, OS;disease control rate, DCR;DOR;TTR;TTP; | — |
Countries
China
Contacts
Public ContactQin Xu
Fujian Cancer Hospital
Outcome results
None listed