Cervical Cancer
Conditions
Interventions
treatment group:chemotherapy combined with Tislelizumab
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women = 20 years of age and patients must be premenopausal and wish to preserve fertility. 2. Squamous cervical cancer or adenocarcinoma in FIGO 2018 stage IB1-IB3 or IIIC1r on physical examination and MRI 3. At time of registration, patient may not have had any prior therapy to treat their cancer lesion. 4. Patient must have disease that is measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 5. Eastern Cooperative Group (ECOG) performance status 0 or 1. 6. Patients must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least one year after the fertility-sparing surgery (FSS) procedure. A serum pregnancy test within 72 hours prior to study registration is required. 7. Patients must have normal organ and marrow function. 8. Ability to understand and willing to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Has a history of infertility. 2. Patients who have had chemotherapy or radiotherapy, immunotherapy, herbal treatment or surgery for their cancer. 3. Is currently participating in or has participated in a study of an investigational agent or has used antineoplastic therapy within 28 days . 4. Has received prior therapy with Checkpoint inhibitor drugs . 5. Has received a major surgery within 4 weeks prior to signing informed consent or The incision did not heal completely. 6. Dramatic pleural effusion, pericardial effusion, or ascites require repeated drainage during the 2-week period prior to initial administration of the study drug. 7. Has a known any active malignancy tumor, excluded of Basal cell carcinoma of the skin or carcinoma in situ of the breast after radical resection 8. Has a known history of active autoimmune disease or an recurrent auto-immune disease . 9. Has a known history of Human Immunodeficiency Virus (HIV) infection or active infection 10. During screening period HBV DNA=104 copy number/mL 11. Has had an allogeneic tissue/solid organ transplant 12. Has received a live vaccine within 4 weeks. 13. Regardless of any other medical condition, metabolic disorder or abnormal laboratory test, researchers reasonably suspected that the patient was unsuitable for the study drug, would interfere with the interpretation of the study results, or put the patient at high risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate;3-year disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| pregnancy rate;objective response rate;live birth rate;malformation rate; | — |
Countries
China
Contacts
Public ContactDanbo Wang
Liaoning Cancer Hospital & Institute
Outcome results
None listed