Locally advanced cervical cancer
Conditions
Interventions
Experimental group:Neoadjuvant therapy with ipalolitovorelimab in combination with chemotherapy
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. IB3, IIA2, >=4cm stage IIB/IIIC1r cervical cancer (2018 FIGO stage) without any prior anti-tumor therapy; 2. Pathologic diagnosis of cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma; 3. Age 18~70 years old, female; 4. ECOG score 0~1; 5. At least one measurable lesion according to RECIST 1.1 criteria; 6. There are no serious blood, heart, lung, liver, kidney function abnormalities and immunodeficiency diseases, and the functional level of organs must meet the following requirements: (1) Blood routine: ANC>=1.5×10^9/L; PLT>=90×10^9/L; Hb>=90g/L; (2) Blood biochemistry: TBIL=50 mL/min; (3) Cardiac ultrasound: left ventricular ejection fraction >= 50%; 7. Women of childbearing age have a negative pregnancy test and are not lactating, and subjects of childbearing potential must receive effective medical contraception (within 6 months from signing the informed consent form to the last study dose); 8. Subjects voluntarily joined this study, signed informed consent, had good compliance and were willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, etc.); 2. Concomitant treatment with other anti-tumor drugs; 3. Participated in other drug clinical trials within 4 weeks before enrollment, and received major surgical treatment, incisional biopsy or obvious traumatic injury (except for the diagnostic biopsy of primary breast cancer); 4. Other malignant tumors within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin; 5. Subjects with any severe and/or uncontrolled disease; 6. Those who are known to have a history of allergy to the drug components of this protocol; 7. Subjects with active infectious disease; 8. Have a history of immunodeficiency, including a positive HIV test, HCV, active viral hepatitis B or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 9. Have any previous cardiac disease, including: cardiac arrhythmia requiring medication or clinical significance; Myocardial infarction; Heart failure; Any other cardiac disease, etc., judged by the investigator to be unsuitable for participating in this trial; 10. Pregnant and lactating female patients, female patients of childbearing potential and positive baseline pregnancy test test; 11. According to the judgment of the investigator, there are serious concomitant diseases that endanger the safety of patients or affect the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, etc. that cannot be controlled by drugs); 12. Previous clear history of neurological or psychiatric disorders, including epilepsy or 13. Any other condition that, in the opinion of the investigator, the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate, pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Event-free survival, EFS;Disease-free survival, DFS;Overall survival, OS;Adverse events, AE; | — |
Countries
China
Contacts
Public ContactLi Min
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed