cervical cancer
Conditions
Interventions
Case series:Anlotinib plus Albumin taxol/cisplatin
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma was pathologically confirmed at the initial treatment.The following rare pathological types of tumors are not included: micropartial adenocarcinoma, villous tubular adenocarcinoma, clear cell carcinoma or sarcoma etc. 3. The enrolled patients need to be confirmed with recurrence by histology or imaging, or the disease is in the advanced stage evaluated by the researcher. 4. The patient did not receive any anti-tumor therapies (including chemotherapy, radiotherapy and traditional Chinese medicine treatment etc.) within one month before the treatment, and the initial platinum-chemotherapy was more than 6 months. 5. At least one measurable lesion (according to RECIST 1.1, CT results of tumor lesion, physical examination or gynecological examination, long diameter =10mm, and CT scan of lymph node lesion, short diameter =10mm) 6. ECOG score: 0-2; 7. Life expectancy = 3 months; 8. The subjects recovered from the damage caused by other treatments, in which they received nitroso or mitomycin at an interval of >=6 weeks;Received other cytotoxic drug, radiotherapy or surgery >=4 weeks, and the wound was completely healed; 9. The main organs function normally, that is, they meet the following standards: (1) Blood routine examination standards shall be met (no blood transfusion or blood products received within 14 days) : 1) ANC >=1.5 x 10^9/L; 2) PLT >=80 x 10^9/L or higher; (2) Biochemical examination shall meet the following standards: 1) TBIL45 ml/min (Cockcroft-Gault formula); 10) Should use a medically approved contraceptive method (e.g., iUD, contraceptive pill or condom) during the treatment and within 1 month after the study in patients with potential fertility;Serum or urine HCG must be negative within 72 hours before study inclusion and must be in non-lactation period; 11. Subjects voluntarily participate in this study and sign informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Tumor-related symptoms and treatment: (1) Uncontrollable, medium to large pleural, peritoneal, or pericardial effusion, requiring drainage repeatly; (2) Imaging (CT or MRI) shows that the tumor invades the large vessels or the researchers judge that the tumor is very likely to invade the important vessels and cause fatal hemorrhage during the follow-up study; (3) Prior to receiving anti-angiogenesis therapy, or other VEGFR inhibitors treatment; 2. Concomitant disease/history: (1) Subjects with any known or suspected autoimmune disease, except: hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy;Subjects with stable type 1 diabetes in which blood sugar is controlled; (2) Hypertension, and cannot get controlled through antihypertensive drugs (systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg); In the 6 months before randomization, patients with myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or above cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure should be excluded; (3) Patients with interstitial lung disease, non-infectious pneumonia or uncontrollable systemic disease (e.g., diabetes mellitus, pulmonary fibrosis, acute pneumonia, etc.); (4) Received live attenuated vaccine within 28 days before the first study or will receive live attenuated vaccine during the following study; (5) Infected Human immunodeficiency virus (HIV) 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 detection limit) or hepatitis B and C co-infection; (6) Severe infection occurred within 4 weeks prior to the first administration, including but not limited to bacteremia requiring hospitalization and severe pneumonia etc;Or an active CTCAE >=2 infection requiring systemic antibiotics within 2 weeks prior to first administration; or a fever of unknown cause >38.5 degree C occurring during screening/prior to first administration (as determined by the investigator, fever caused by tumor can be included); Evidence of active TB infection within 1 year before administration; (7) Had been diagnosed with any other malignant tumor within 5 years before entering the study, except basal cell carcinoma or squamous cell carcinoma or carcinoma in situ of the cervix after adequate treatment; (8) There is a significant clinical significance of intestinal obstruction; (9) subjects who have received or are about to receive allogeneic bone marrow transplantation or solid organ transplantation; (10) peripheral neuropathy >=2; 3. Bleeding tendency disease: (1) events of arteriovenous thrombosis (AVT) in the first 6 months of randomization, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except for venous thrombosis caused by intravenous catheterization due to previous chemotherapy and confirmed by the investigator to be cured) and pulmonary embolism etc; (2) Subjects with cough up blood symptoms and maximum daily hemoptysis >=2.5ml within 2 months before entering the study. Clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above at baseline, or vasculitis, were observed within 3 months before the study.Hereditary or acquired bleeding and thrombotic tendenc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR; | — |
Countries
China
Contacts
Public ContactGAO FUFENG
Shandong Cancer Hospital
Outcome results
None listed