locally advanced cervical cancer
Conditions
Interventions
Test group:Apalophoritovolrelizumab (QL1706) 5 mg/kg+paclitaxel for injection (albumin bound) 260 mg/m ^ 2+cisplatin for injection 75 mg/m ^ 2, once every 3 treatment cycles, for a total of 3 cycles
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced cervical cancer (stage IB3, IIA2 and IIIC1r without parametrial invasion, according to figo2018 staging system); 2.They had not received any systemic or local anti-tumor treatment for cervical cancer before enrollment, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc. 3. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma; 4. Age >=18 years and 4 cm and radiographic stage IIIC1r pelvic lymph node short diameter >=1.5cm); 6. No distant organ metastasis, short diameter of para-aortic lymph nodes =12 months; 9. The functional level of the organ must meet the following requirements. Samples had to be obtained 3 days before the start of the study intervention. (1) Hematology: absolute neutrophil count =3.5×10^9/L, platelet =80×10^9/L, hemoglobin >=90g/L(without blood transfusion or use of blood products within the past 14 days); (2) Kidney: serum creatinine, urea nitrogen = upper limit of normal value; (3) liver: total bilirubin <=1.5 times upper limit of normal value; ALT and AST <=1.5 times the upper limit of normal; (4) Coagulation: prothrombin time (PT) <=1.5 times upper limit of normal value, international normalized ratio (INR) <=1.5 times upper limit of normal value, activated partial thromboplastin time (APTT) <=1.5 times upper limit of normal value; (5) Endocrine: thyroid stimulating hormone (TSH)<= the upper limit of normal value (if abnormal, FT3 and FT4 levels should be examined at the same time, if FT3 and FT4 levels are normal, they can be enrolled; 10. Women of childbearing age should take reasonable contraceptive measures; 11. The subject (or legal representative) has provided the informed consent for the study; 12. The subjects agreed to collect the tumor tissue and peripheral blood samples needed during the screening period and the research process and apply them to the related research. 13. As judged by the investigator, the participant was willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study;
Exclusion criteria
Exclusion criteria: 1. Major uncontrolled cardiovascular or cerebrovascular disease within 6 months before the study intervention, including New York Heart Association class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, or other major distracting cerebrovascular disease; 2. Have active or known or suspected autoimmune disease requiring systemic treatment, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention. 3. The patient has uncontrolled systemic disease, such as active infection requiring systemic treatment; 4. Urine routine examination showed that urine protein >=++, and 24-hour urine protein >1.0 g; 5. Have any primary tumor within 5 years (except cured skin basal cell carcinoma, thyroid papillary carcinoma, etc.); 6. Received any previous systemic antitumor therapy; 7. Previous treatment with immune checkpoint inhibitors (including but not limited to other anti-PD-1, anti-PD-L1, and anti-CTLA-4 antibodies); 8. Previous allogeneic bone marrow transplantation or organ transplantation; 9. Patients were enrolled in other drug clinical trials within 4 weeks before enrollment; 10. Active bleeding occurred within 3 months; Severe arterial/venous thrombosis occurred within 6 months; Hereditary or acquired bleeding (e.g. coagulopathy); 11. Major surgery (other than biopsy or polypectomy), incomplete healing of surgical incision, or major trauma within 4 weeks before the study; Fractures or wounds that have not healed for a long time; 12. Currently using or taking aspirin (> 325 mg/ day), dipyridamole, clopidogrel, or cetazole (10 days before study); 13. The subject has not fully recovered from major surgery or has ongoing surgical complications; 14. Have a medical condition requiring low-dose systemic corticosteroid therapy within 1 month or high-dose systemic corticosteroid therapy within 3 months before enrollment; 15. Inactivated vaccine administered within 4 weeks before enrollment; 16. Known HIV positive or AIDS patients; Or combined with active hepatitis B (HBsAg positive and/or HBV DNA positive) and active hepatitis C (anti-HCV antibody positive and HCV RNA positive) infection; 17. Unwilling or unable to sign informed consent; 18. Pregnant or lactating women; 19. A history of substance abuse, alcohol or drug abuse; 20. Hypersensitivity to apalorito volrelizumab (QL1706), paclitaxel (albumin-bound), cisplatin or intolerance to any of their excipients; 21. There is historical or current evidence of any disease, treatment, laboratory abnormality, or other condition that may interfere with the results of the study or preclude full participation in the study to the extent that the investigator believes that participation in the study is not in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete Response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical resection rate;overall survival;Optimal response Rate;Event-free survival;Objective response rate (ORR);Incidence of adverse events related to neoadjuvant therapy; | — |
Countries
China
Contacts
Public ContactMa Rong
Harbin Medical University Cancer Hospital
Outcome results
None listed