Cervical cancer
Conditions
Interventions
Treatment group:Cadonilimab + paclitaxel liposome + cisplatin
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects are able to understand the informed consent form, voluntarily participate and sign the informed consent form; 2. Female, aged 18-75 years old; 3. Histopathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; 4. Local advanced tumors that have not received any treatment in the past (tumor diameter>=4cm) refer to cervical cancer patients in stage IB3 and IIA2 of FIGO staging (confirmed by imaging); 5. During the screening period, patients must provide tumor tissue slices; Send tumor histopathological samples embedded in formalin fixed paraffin or fresh tumor histopathological samples to the central laboratory for PD-L1 expression detection; 6. ECOG score 0-1 points; 7. Normal function of major organs, i.e. meeting the following criteria: 1) The blood routine examination must comply with (no blood transfusion, no use of hematopoietic factors, and no medication correction within 14 days): a. ANC>=1.5 × 109/L; b. PLT>=100 × 109/L; c. HB>=90 g/L; 2) Biochemical examination must meet the following standards: a. TBIL=50mL/min (Cockcroft Gault formula); 3) Coagulation function must meet: INR<=1.5 × ULN and APTT<=1.5 × ULN; 8. Female participants of childbearing age must undergo a serum pregnancy test within 3 days before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method (such as an intrauterine device, contraceptive, or condom) during the study period and within 3 months after the last administration of the study medication; 9. Before the start of treatment, the ejection fraction on the echocardiography was greater than 50%; 10. The subjects are capable and willing to comply with the visit, treatment plan, laboratory tests, and other research related procedures stipulated in the research protocol.
Exclusion criteria
Exclusion criteria: 1. The subject has received radiotherapy and chemotherapy, immunotherapy, traditional Chinese medicine treatment or surgery for cervical cancer; 2. Major surgical surgery (except biopsy) performed within 4 weeks prior to the first study drug treatment or surgical incision not completely healed; 3. Previous anti-PD-1, anti-PD-L1, or anti-CTL-A4 antibody therapy, or any other antibody or drug with T-cell co-stimulation or checkpoint pathway as a specific target; 4. Other malignant tumors in the past 5 years; 5. Uncontrollable pleural effusion, pericardial effusion or ascites; 6. Severe cardiovascular disease, such as symptomatic coronary heart disease, congestive heart failure of grade >= II, uncontrolled arrhythmia, myocardial infarction within 12 months before enrollment; 7. Complicated by severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; 8. Have uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; known history of HIV infection or AIDS; Active syphilis; active tuberculosis; Active infection; uncontrolled hypertension, symptomatic cardiac insufficiency; Active bleeding; 9. Have a history of interstitial lung disease (except radiation pneumonia that has not been treated with national hormones) and non-infectious pneumonia; 10. Allergic reaction to the drugs used in this study; 11. Use of steroids or other systemic immunosuppressive therapy 14 days prior to recruitment; 12. Previous allogeneic stem cell transplantation or organ transplantation; 13. Have received a live vaccine within 4 weeks (inclusive) before the first administration of the study drug; (Note: Seasonal injections of influenza vaccines are usually inactivated vaccines, so they are permitted.) Intranasal vaccines are live vaccines, so they are not allowed) 14. Pregnant or lactating women or women of childbearing age who have a positive baseline pregnancy test; 15. Patients assessed by investigators to have poor patient compliance and could not guarantee treatment and follow-up according to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major response rate;Overall response rate;Disease control rate;Disease-free survival;Overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactLiu Chang
The First Hospital of Lanzhou University
Outcome results
None listed