Locally advanced cervical cancer
Conditions
Interventions
Treatment group:Radiotherapy combined with immunomaintenance therapy
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
Female
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written ICF; 2. Female, aged >= 70 years old; 3. Cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma) confirmed by histology or pathology, stage IIB-IVA of FIGO 2018; 4. Newly treated, who have not received surgery, radiotherapy, chemotherapy, immunotherapy, biological therapy, etc. 5. Before the start of chemoradiotherapy, CT or MRI has at least one measurable lesion; 6. ECOG 0-1 points; 7. Samples can be provided for PD-L1 testing (voluntary testing); 8. Predicted survival expectation of not less than 3 months; 9. Refusal of concurrent chemotherapy ; 10. Have adequate organ and bone marrow function:; (1) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; (2) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil count (ANC) >= 1.5×10^9/L; (3) In the case of no blood transfusion in the past 14 days, platelets (PLT) >= 9×10^9/L; (4) total bilirubin (TBIL) = 50mL/min (Cockcroft-Gault formula); (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range, If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 11. Voluntarily comply with the visits, treatment plans, laboratory tests, and other requirements of the study specified in the schedule.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies targeting ICOS, CD40, CD137, GITR, and Ox40 targets, etc.), immune cell therapy, etc. Any therapy that targets the immune mechanisms of the tumour.; 2. Patients with mental disorders who are unable to cooperate with treatment; 3. Patients with active autoimmune disease or a history of autoimmune disease that may recur; Note: Patients with the following diseases are not excluded and can proceed to further screening: a. Controlled type 1 diabetes mellitus; b. Hypothyroidism (if controlled with hormone replacement therapy alone); c. Controlled coeliac disease;d. Skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia); e. Any other disease that is not expected to recur in the absence of external triggers; 4. Any active malignancy within 2 years grade 1 potassium, sodium, or corrected calcium levels 14 days prior =3 hypoalbuminemia despite standard drug therapy; 7. History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, hypertension, etc. 8. Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibiotic, antibacterial or antiviral therapy prior to enrolment or within 14 days prior to the first dose of study drug; 9. Known history of HIV infection; 10. Patients with untreated chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA >= 2000 IU/mL or active hepatitis C virus (HCV) carriers should be excluded. Note: Patients with in active hepatitis B surface antigen (HBsAg), treated and stable hepatitis B patients (HBV DNA =2 ventricular arrhythmia within 6 months prior to enrollment or the first dose of study drug <= History of cerebrovascular accident prior to enrollment or within 6 months prior to the first dose of study drug 14. History of severe hypersensitivity reaction to other monoclonal antibodies or any ipalolitovorelimab injection; 15. Current presence of radiographi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Progression-Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time;Quality of Life;Duration of Response;Progression-Free Survival time;Objective response rate;Disease control rate;security; | — |
Countries
China
Contacts
Public ContactDan Li
The affiliated hospital of southwest medical university
Outcome results
None listed