Cervical cancer
Conditions
Interventions
treatment group:Subjects received two cycles of induction therapy with anlotinib + paclitaxel/cisplatin and then received anlotinib + concurrent chemoradiotherapy sequential high-dose rate intralumina
Sponsors
Gansu Provincial Maternal and Child Health Care Hospital/Gansu Provincial Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperation with the follow-up visit 2. Age= 18 years old (calculated on the day of signing informed consent) 3. Patients diagnosed with cervical cancer by pathology or histology, including squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, small cell neuroendocrine carcinoma, and have measurable lesions 4. Including the following locally advanced patients patients who are to be treated with concurrent chemoradiotherapy, ,with FIGO stage IIIC-IVA 5. ECOG score of 0-2 points 6. Expected survival time > 3 months 7. Tolerated with this study protocol and good organ function, please refer to the following: a) Neutrophil count = 1500/µL b) White blood cell count = 3000/mm3 c) Platelet = 100,000/µL d) Hemoglobin = 10g/dL e) Serum creatinine =1.5 times the upper limit of normal value, or creatinine clearance = 60mL/min (calculated according to the Cockcroft-Gault formula) f) Total bilirubin = 1.5 times the upper limit of normal value or direct bilirubin = 1.0 times the upper limit of normal value g) AST and ALT = 2.5 times the upper limit of normal value, and =5 times the upper limit of normal value must be in the presence of liver metastases h) Serum calcium= 2.5 times the upper limit of normal value i) Urine protein < 1000mg (24-hour urine collection) 8. Females of childbearing age who have a negative pregnancy test result at the time of enrollment and promise to take adequate and effective contraceptive measures or abstinence from the beginning of the study to the end of the study, and within 3 months after the last administration of the study drug can be enrolled in this study.
Exclusion criteria
Exclusion criteria: Patients with any of the following cannot be enrolled in this study: 1. Female subjects who are pregnant, lactating, or planning to become pregnant during the study 2. Patients with contraindications to anti-angiogenic drugs 3. Previous pelvic external beam radiation therapy (including transvaginal brachytherapy) 4. Major surgery or open biopsy within the past 28 days 5. Previous systemic chemotherapy 6. Estimated survival 140 mmHg or diastolic blood pressure > 90 mmHg, or blood pressure >160/90 mm Hg while taking medication) d) Within 6 months prior to randomization, the following conditions have occurred: myocardial infarction within the past 12 months, severe/unstable angina, NYHA grade 3-4 cardiac insufficiency, supraventricular or ventricular arrhythmias requiring medication, and symptomatic congestive heart failure e) Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g. diabetes, pulmonary fibrosis and acute pneumonia, etc.) f) Renal insufficiency: urine routine shows urine protein =++, or confirmed 24-hour urine protein volume = 1.0g g) History of live attenuated vaccination within 28 days prior to the first study administration or expected live attenuated vaccination during the study period h) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA = 500 IU/ml; Hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C i) Severe infection within 4 weeks prior to the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; Active infection of CTCAE=2 grade 2 requiring treatment with systemic antibiotics within 2 weeks prior to the first dose, or unexplained fever >38.5°C during the screening period/before the first dose (as judged by the investigator, fever due to tumor causes can be enrolled); Evidence of active tuberculosis infection within 1 year prior to dosing j) Diagnosis of any other malignancy within 3 years prior to study entry, with the exception of adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ of the cervix k) Major surgery within 28 days prior to randomization (tissue biopsy and peripherally venous catheter placement [PICC] required for diagnosis are permitted) l) Subjects who have received or are preparing to undergo allogeneic bone marrow transplantation or solid organ transplantation in the past m) Peripheral neuropathy = grade 2; Patients with active brain metastases, carcinomatous meningitis, spinal cord compressio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate of tumor biomarkers(The proportion of patients with CA199 and SCCA decreased to normal range);12-month recurrence-free survival rate;Overall Survival;Duration Of Response;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactGao Liying
Gansu Provincial Maternal and Child Health Care Hospital/Gansu Provincial Central Hospital
Outcome results
None listed