Newly diagnosed recurrent or metastatic endometrial cancer.
Conditions
Interventions
Experimental group:Atezo combination antibody combined with chemotherapy
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written ICF; 2. Age >=18 years old, =3 months; 5. Histologically confirmed stage III/IV or recurrent endometrial cancer, who have not received first-line systemic anti-cancer therapy, and are not suitable for other treatments other than systemic therapy (such as inoperable or intolerant surgery, not suitable for radiotherapy, etc.); 6. Presence of measurable lesions with the following requirements: at least 1 measurable lesion according to the Efficacy Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1), and > for non-lymph node lesions with a long diameter of >=10 mm or a short diameter of lymph node lesions= 15 mm lymph node, and can be measured repeatedly. Lesions receiving external beam radiation therapy (EBRT) or locoregional therapy (e.g., radiofrequency ablation) must show subsequent evidence of substantial increase in size to be considered target lesions; 7. Good function of major organs: Hematology (no use of any blood components and cell growth factor supportive therapy within 7 days prior to initiation of study treatment): Absolute neutrophil ANC > = 1.5 ×10 9 /L (1,500/mm3). Platelet count > = 100 × 10 9/L (100,000/mm3). Hemoglobin > = 100 g/L. Renal: Creatinine clearance * (CrCl) calculated value > = 40 mL/min. CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft-Gault formula) CrCL (mL/min) = [(140 - age) × body weight (kg) × F]/ (SCr (mg/dL) × 72) where F=1 for males and F=0.85 for females; Urine protein =28 g/L. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) =50%. 8. Female subjects of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed to be negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result is negative. If a female subject of childbearing potential has sexual activity with a non-sterilized male partner, the subject must be using an acceptable method of contraception from screening and must agree to continue using a method of contraception for 120 days after the last dose of study drug; Whether to discontinue contraception after this time point should be discussed with the investigator; 9. Subjects are willing and able to comply with the visits, treatment protocols, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Participated in the treatment of experimental drugs or used experimental devices within 4 weeks prior to the first administration of QL170; 2.nroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study (defined as more than 4 weeks from the first dose to the last dose of the previous clinical study or more than 5 half-lives of the study drug, whichever is longer); 3.Suffering from carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma, or other high-grade sarcomas, or endometrial stromal sarcoma; 4.Has had any other active malignancy within 2 years prior to enrollment. Excludes locally curable malignancies (demonstrated to be), such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, or cervical or breast carcinoma in situ; 5.The subject has a history of active autoimmune disease requiring systemic therapy within 2 years prior to the start of treatment, or in the opinion the investigator, has an autoimmune disease that is likely to recur or planned to be treated; the following exceptions apply: dermatologic conditions (e.g., vitiligo, alopecia, psoriasis, or eczema) not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis that requires only stable doses of hormone therapy; well-controlled type 1 diabetes mellitus; childhood asthma that has resolved completely and requires no intervention as an adult; or a disease that, in the of the investigator, is unlikely to recur in the absence of an external trigger; 6.Active or clinically significant inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea); 7.Known human immunodeficiency virus or known acquired immunodeficiency syndrome test positive history; 8.Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 9.Known to have interstitial lung disease or history; 10.History of gastrointestinal perforation and/or fistula within 6 months prior to enrollment; 11.The subject has necrotic lesions found during the screening period within 4 weeks before enrollment, and the investigator judges that there is a risk of major bleeding; 12.Serious infection within 4 weeks prior to the first dose, including but not limited to complicated infections requiring hospitalization, sepsis, or severe pneumonia; 13.Known to have active pulmonary tuberculosis (TB). Suspected of having active TB, the subject needs to be examined with chest X-rays, sputum, and exclusion by clinical symptoms and signs; 14.Untreated chronic hepatitis B patients or chronic hepatitis B virus (HBV) carriers with HBV DNA > 1000 IU/mL, and patients with active hepatitis C should be excluded. Inactive hepatitis B surface antigen (HbsAg) carriers, treated and stable hepatitis B patients (HBV DNA <1000 IU/mL), and cured hepatitis C patients can be enrolled. For subjects positive for HCV Ab, they are eligible to participate in the study only if the HCV RNA test result is negative; 15.It is known that there are leptomeningeal metastases, spinal cord compression, leptomeningeal disease, or active brain metastases. However, patients with measurable lesions outside the central nervous system that meet the following criteria are eligible for enrollment: no prior treatment, currently asymptomatic (e.g., no neurological deficits, seizures, or other typical signs and symptoms of central nervou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Duration of Response (DoR);Overall survival (OS);security; | — |
Countries
China
Contacts
Public ContactXiang Yang
Peking Union Medical College Hospital
Outcome results
None listed