Cervical Cancer
Conditions
Interventions
Case series:paclitaxel+cisplatin+sintilimab
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients aged >=18 years: 2. Histologically confirmed squamous cell, adenocarcinoma, or adenosquamous cervical cancer; 3. Recurrent cervical cancer without prior systemic chemotherapy for recurrent disease, not amenable for curative treatment with surgery and/or radiation therapy, or patients refuse surgery and/or radiation therapy; 4. Persistent Cervical cancer: measurable disease by RECIST v1.1 criteria after primary treatment; 5. Histologically confirmed diagnosis of metastatic cervical cancer (stage IVB); 6. Tumor specimen and blood sample are mandatory at study entry; 7. Measureable disease by RECIST v1.1 criteria; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 9. Life expectancy >=12 weeks; 10. Adequate organ and marrow function as defined below: 1) White blood cell >=3.0x10^9/L, Absolute neutrophil count >=1.5x10^9/L, Platelets >=100x10^9/L, Hemoglobin >=9 g/dL; 2) Liver function: Total serum bilirubin 50% in ultrasonic cardiogram; 11. Signed informed consent before any study-specific procedure.
Exclusion criteria
Exclusion criteria: 1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication; Chemotherapy, radiotherapy, targeted therapy or other anticancer therapy within 2 weeks prior to entering the study; 2. Any unresolved toxicity of CTCAE grade >=2 from previous anticancer therapy (alopecia and peripheral neuropathy =104 copies /ml; 13. Patients with clinically significant cardiovascular disease, this includes: Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg; Myocardial infarction 450 ms calculated from consecutive electrocardiograms (EKGs); 14. Abnormal thyroid function that cannot maintained in normal range by use of medicine; 15. Electrolyte abnormalities need clinical intervention; 16. Receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to therapy; 17. Receipt of live attenuated vaccine within 4 weeks prior to the first dose of investigational treatment. Note: patients, if enrolled, should not receive live vaccine during
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Safety and Survivability; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DoR;PFS;OS; | — |
Countries
China
Contacts
Public ContactZheng Hong
Peking University Cancer Hospital
Outcome results
None listed