Endometrial cancer
Conditions
Interventions
Group A( QL1706 + carboplatin + paclitaxel):Paclitaxel 135~175 mg/m^2, intravenous infusion, at least 3 hours
Carboplatin AUC 4~5, intravenous infusion, at least 1 hour
QL1706 5 mg/kg, 30~60 minute intravenous infusion, combined with chemotherapy every 3 weeks.
Group B (carboplatin + paclitaxel):Paclitaxel 135–175 mg/m^2, intravenous infusion, at least 3 hours
Carboplatin AUC 4–5, intravenous infusion, at least 1 hour, repeated every 3 weeks
Sponsors
Nantong Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the written ICF; 2. Age at enrollment >=18 years and =3 months; 5. Histologically confirmed metastatic/recurrent endometrial cancer that has not received first-line systemic anticancer therapy; 6. Presence of measurable lesions meeting the following criteria: At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); for non-lymph node lesions, the longest diameter >=10 mm, or for lymph node lesions, short-axis diameter >=15 mm, and these lesions must be repeatedly measurable. Lesions that have received external beam radiation therapy (EBRT) or local regional treatment (e.g., radiofrequency ablation) must show subsequent evidence of substantial size increase to be considered target lesions; 7. Major organ functions are good: Hematology (no use of any blood components or growth factor support within 7 days prior to the start of treatment): Absolute neutrophil count (ANC) >= 1.5 ×10^9 /L (1500/mm^3); Platelet count >= 100 ×10^9 /L (100,000/mm^3); Hemoglobin >= 100 g/L. Kidney: Creatinine clearance (CrCl) >= 40 mL/min; CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft-Gault equation) CrCL (mL/min) = [(140 - age) × weight (kg) × F] / (SCr (mg/dL) × 72), where F = 1 for males, F = 0.85 for females; SCr = serum creatinine; Urine protein = 28 g/L. Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 50%. 8. The subject is willing and able to comply with scheduled visits, treatment regimens, laboratory tests, and other study requirements.
Exclusion criteria
Exclusion criteria: 1. Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention; 2. Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known allergy to any component of the investigational drug or other monoclonal antibodies; 3. History of human immunodeficiency virus (HIV) infection, or known active hepatitis B or C; 4. Use of immunosuppressive drugs or systemic corticosteroids within 2 weeks before the investigational drug to achieve immunosuppression (>10 mg/day of prednisone or equivalent); 5. History of other primary malignant tumors; 6. Participation in another clinical trial at the same time; 7. Pregnant or breastfeeding women; subjects of childbearing potential who have not been surgically sterilized must agree to use effective contraception during the study treatment and for 3 months after the end of study treatment; 8. Uncontrolled comorbidities, including but not limited to: cardiac disease: New York Heart Association (NYHA) class >2, severe/unstable angina, myocardial infarction within 6 months before study drug administration, serious arrhythmias requiring medication or intervention; difficult-to-control hypertension; cerebrovascular accident or brain disease within 6 months before study drug administration, impaired judgment; hematologic disorders: coagulation abnormalities (INR>2.0, PT>16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; liver or kidney developmental abnormalities or surgical history; active infection requiring systemic anti-infective therapy within 14 days prior to first dose of drug; 9. Vaccination with live or attenuated vaccines within 4 weeks prior to first study drug administration. Note: administration of seasonal inactivated influenza vaccine is allowed; 10. Patients who have previously undergone allogeneic bone marrow transplant or solid organ transplant; 11. Drug and/or alcohol abuse; 12. Unable or unwilling to sign the informed consent form; 13. Patients deemed by the investigator as unlikely to comply with study procedures, restrictions, and requirements are not allowed to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression-Free Survival (PFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactLi Yong
Nantong Cancer Hospital
Outcome results
None listed