cervical cancer
Conditions
Interventions
Interventional study:Sequential Cisplatin/Paclitaxel and Tislelizumab
Sponsors
Jiangmen Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The clinical diagnosis cervical cancer according to FIGO 2018 stages are IB3, IIA2 and IIIC1r with local tumour maximum diameter =4cm. 2. Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma. 3. Ages 18-70 year. 4. ECOG 0-1 and expected survival =6 months. 5.WBC=3.5×109/L,Hb=100g/L,PLT=90×109/L when routine analysis of blood. Cardiac and liver function well(TBil=1.5ULN, ALT=2.5ULN, AST=2.5ULN), kidney funtion well(serum Cr=1.5ULN) ,coagulation function well. 6. No other antitumor concomitant therapy (including steroid drugs) 7. No other serious diseases conflict with this study 8. Without previous surgery, radiation or systemic treatment for cervical cancer 9. Agree with chemotherapy and related therapy. Sign informed consent for this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Previous immunotherapy, including immune checkpoint inhibitory antibodies (such as anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint agonist antibodies (such as anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy; Prior receipt of VEGF/VEGFR inhibitors such as bevacizumab, ramucirumab, aflibercept, and tyrosine kinase inhibitors. 2. Systemic infection or other serious infection requiring intravenous antibiotics > 7 days of treatment within 2 weeks prior to enrollment, or fever of unknown cause > 38.5 degrees during the screening period and before enrollment (except for fever caused by tumor in the judgment of the investigator). 3. Presence of disease requiring systemic use of corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks prior to enrollment. Topical corticosteroids, nasal sprays, and inhaled steroids are allowed. Systemic corticosteroids are allowed for the prevention of contrast allergy. 4. Received systemic therapy with immunomodulatory drugs (such as thymopeptide, lentinan polysaccharide, interferon, interleukin, etc.) within 2 weeks prior to enrollment. 5. Treatment with aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), dipyridamole, ticlopidine, and cilostazol within 2 weeks prior to enrollment and the use of other anticoagulant therapy for therapeutic purposes (except for low molecular weight heparin therapy). 6. Within 2 weeks prior to enrollment, have received modern traditional Chinese medicine preparations approved by NMPA for anti-tumor treatment. 7. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to enrollment; or requires elective major surgical treatment during the study. Received local invasive procedures (such as needle core biopsy) within 1 week prior to enrollment, except for the placement of vascular access devices. 8. Received anti-tumor therapy, such as chemotherapy, endocrine therapy, targeted therapy, biological therapy, tumor embolization, etc., within 4 weeks before enrollment. 9. Presence of symptomatic central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression due to metastases prior to signing informed consent. Patients who are asymptomatic and have clinical and/or radiographic evidence that their condition is stable, who have stopped treatment with corticosteroids and anticonvulsants for at least 2 weeks, and who do not require further treatment (radiotherapy, surgical resection, and/or corticosteroid therapy) may participate in this study. 10. Currently have clinically significant hydronephrosis, which cannot be relieved by nephrostomy or ureteral stenting as judged by the investigator. 11. At present, there is a third space effusion with poor clinical control and requires repeated puncture and drainage. 12. Have an active or potentially recurrent autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; Hypothyroidism due to autoimmune thyroiditis requiring only stable doses of hormone replacement therapy; Type I diabetes requiring only stable doses of insulin replacement therapy. 13. History of gastrointestinal perforation or fistula, genitourinary fistula, intra-abdominal abscess within 6 months prior to enrollment, and it is acceptable if the underlying factors leading to perforat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;2-year PFS rate; | — |
Countries
China
Contacts
Public ContactXiaohong Ruan
Jiangmen Central Hospital
Outcome results
None listed