Locally advanced cervical cancer
Conditions
Interventions
experimental group:Envafolimab combined with Endostar and concurrent chemoradiotherapy
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for this study: 1. age: 18 to 75 years; 2. ECOG score: 0-1; 3. expected survival = 3 months; 4. histologically or pathologically confirmed locally advanced cervical cancer that is not suitable for surgery or refuses surgery.It does not include the following rare pathological types of tumors: minimal deviation adenocarcinoma, villous tubular adenocarcinoma, clear cell carcinoma or sarcoma; histological or cellular scholars cannot be obtained, and clinical diagnosis can be provided in combination with medical history, laboratory tests and imaging tests (such as CT, MRI, PET/CT); 5. previous systemic treatment, efficacy evaluation PR or SD; no radiotherapy; no previous treatment with other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1; no VEGFR inhibitors, such as sorafenib, sunitinib; 6. at least one measurable lesion (according to RECIST 1.1 criteria, tumor lesion CT scan long diameter = 10 mm, lymph node lesion CT scan short diameter = 10 mm); 7. normal main organ function, that is, the following criteria should be met: (1) blood routine examination criteria need to meet (no blood transfusion and blood products within 14 days): a. ANC = 1.5 × 10^9/L; b. PLT = 80 × 10^9/L; (2) biochemical tests need to meet the following criteria: a. TBIL 45ml/min (Cockcroft-Gault formula); 8. patients with potential fertility need to use a medically recognized contraceptive (such as intrauterine device, contraceptives or condoms) during study treatment and within 1 month after the end of study treatment; and serum or urine HCG test must be negative within 72h before study enrollment and must be non-lactating; 9.subjects voluntarily join this study, sign informed consent, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Subjects who met the following criteria could not be enrolled in this study: 1. had experienced or currently had other malignancies within 3 years before the start of treatment in this study; 2. could not pass (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.; 3. unresolved toxicity = grade 1 due to any previous treatment (according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 5.0 [CTCAE 5.0]); 4. subjects with any severe and/or uncontrolled disease.These include: 1) unsatisfactory blood pressure control (systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg); 2) suffering from = Grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc = 470 ms) and = Grade 2 congestive heart failure (New York Heart Association [NYHA] classification); 3) active or uncontrolled serious infection (= CTCAE2 infection); 4) cirrhosis, active hepatitis *; active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA test value exceeds the upper limit of normal; hepatitis C reference: HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal); previous HBV infection or HBV infection has been cured (defined as the presence of hepatitis B core antibody [anti-HBc] and the absence of HBsAg) patients are eligible; HCV antibody positive patients can only participate in this study when HCV RNA is negative by polymerase chain reaction (PCR);To prevent viral activation; 5) with a history of (non-infectious) pneumonia/interstitial lung disease requiring steroid therapy or current (non-infectious) pneumonia/interstitial lung disease; 6) active syphilis; 7) renal failure requiring hemodialysis or peritoneal dialysis; 8) a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 5. Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L); 6. Urine routine showed urine protein = +, and confirmed 24-hour urine protein quantification > 1.0 g; 7. Major surgical treatment or significant traumatic injury within 28 days before the start of study treatment; or long-term incurable wounds or fractures; 8. Severe arterial/venous thrombotic events within 6 months before the start of study treatment, such as cerebrovascular accident (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 9. with a history of psychiatric drug abuse and can not quit or mental disorders; 10.Related to study treatment: 1) history of live vaccination within 28 days before the start of study treatment or planned live vaccination during the study period; 2) severe hypersensitivity reactions after the use of monoclonal antibodies; 3) active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressive agents) within 2 years before the start of study treatment, except replacement therapy (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency); 4) diagnosis of immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose > 10 mg/day prednisone or other effective physiological dose hormones), and continued within 2 weeks after the first dose; 5) history of active tuberculosis; 11.Are participating or have participated in other clini
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Objective response rate (ORR);Overall survival (OS);Safety ; | — |
Countries
China
Contacts
Public ContactMingbo Liu
Henan Provincial People's Hospital
Outcome results
None listed