Cervical Cancer
Conditions
Interventions
therapy group:PD-L1 monoclonal antibody + bevacizumab
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma diagnosed by histopathology; 3. Patients with recurrence, metastasis, and persistent cervical cancer who have received at least 1 line of systemic chemotherapy in the past have been assessed by the investigator to be unable to undergo surgery or the patient refuses to undergo surgery, and the investigator has assessed that they cannot be treated with local radical radiotherapy or The patient refused radiotherapy; (1) After initial treatment for persistent cervical cancer, there are still measurable lesions (RECIST 1.1 standard); (2) Metastatic cervical cancer refers to stage IVB cervical cancer diagnosed pathologically; (3) Past systemic chemotherapy does not include: neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and chemotherapy during concurrent chemoradiation; 4. Patients who can provide blood and tumor tissues (15-20 pieces of formalin-fixed paraffin-embedded tissue blocks or anti-detachment tissue slices, within 2 years). Patients who cannot provide archived tumor tissues must agree to provide fresh tissue before receiving treatment Biopsy specimen; 5. At least one measurable lesion (RECIST 1.1 standard); 6. ECOG score 0 or 1 point; 7. Expected survival >= 12 weeks; 8. Sufficient organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 1 week before the first study drug treatment): (1) Blood routine: white blood cells >=3.0 x10^9/L, neutrophils >=1.5 x10^9/L, platelets >= 100 x10^9/L, hemoglobin >=9.0g/dL; (2) Liver function: total bilirubin 50% detected by 2-dimensional echocardiography; (6) Urine routine: urine protein = 2+, a 24-hour urine protein quantitative examination is required, and a 24-hour urine protein quantitative <1000mg. 9. Fully understand this research and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Clinical trials of research drugs or research devices; or received anti-tumor therapy within 2 weeks, including but not limited to chemotherapy, radiotherapy or targeted therapy, excluding endocrine therapy and Chinese medicine therapy; 2. The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level (hair loss, peripheral neurotoxicity caused by chemotherapy =104 copies/ml during the screening period; 19. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, cerebrovascular accident or transient ischemic attack, congestive heart failure within 6 months before enrollment (New York Heart Association grade > 2); In addition to ß-blockers or digoxin, arrhythmias that require other anti-arrhythmic drugs; QTcF interval of 450 milliseconds (ms) for repeated ECG detection; 20. There is abnormal thyroid function, and the use of drugs cannot maintain the thyroid function in the normal range; 21. Clinically significant abnormal serum electro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Safety and Survivability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of relief;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Naiyi
Peking University Cancer Hospital
Outcome results
None listed