Endometrial cancer
Conditions
Interventions
Experimental group:Subjects received QL1706 (5 mg/kg, Q3W, day 1), carboplatin (AUC=5, Q3W, day 1), and paclitaxel (175 mg/m^2, Q3W, day 1) for a total of 8 cycles, followed by maintenance treatment w
Sponsors
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed the written informed consent form (ICF). 2. Female, aged >=18 years and = 6 months. 5. Histologically confirmed Stage III/IV or recurrent endometrial carcinoma, having not received first-line systemic anti-cancer therapy for recurrent/advanced endometrial cancer, and unsuitable for treatments other than systemic therapy (e.g., ineligible for or unable to tolerate surgery, unsuitable for radiotherapy, etc.). 6. Patients with dMMR or pMMR endometrial carcinoma are eligible for inclusion. 7. Presence of measurable lesions meeting the following criteria: (1)At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); the longest diameter of non-nodal lesions must be >=10 mm or the short axis of lymph nodes must be >=15 mm, and the lesions must be reliably measurable on repeated examinations. (2) Lesions previously subjected to external beam radiation therapy (EBRT) or local regional therapy (e.g., radiofrequency ablation) must demonstrate subsequent evidence of substantial size increase to be considered target lesions. 8. Adequate organ function: Hematological (without transfusion or growth factor support within 7 days prior to initiation of study treatment): Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (1,500/mm³). Platelet count >= 100 × 10^9/L (100,000/mm³).Hemoglobin >= 90 g/L. Renal:Calculated creatinine clearance* (CrCl) >= 50 mL/min.CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = [(140 - age) × weight (kg) × F] / (serum creatinine (mg/dL) × 72), where F = 1 for males and 0.85 for females. Urine protein = 28 g/L. Coagulation:International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 50%. 9. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test result is not conclusively negative, a serum pregnancy test is required, and the serum result shall be considered definitive). If sexually active with a non-sterilized male partner, subjects of childbearing potential must use acceptable contraceptive methods starting from screening and must agree to continue such precautions for 120 days after the last dose of study drug; discussion with the investigator regarding contraception discontinuation after this period is required. 10. Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.
Exclusion criteria
Exclusion criteria: 1. Participation in an investigational drug or device study within 4 weeks prior to the first dose of QL1706. 2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study (defined as the time from the first dose in the current study being at least 4 weeks after the last dose in the previous clinical study, or more than 5 half-lives of the investigational product from the previous study, whichever is longer). 3. History of carcinosarcoma (malignant mixed Müllerian tumor), endometrial leiomyosarcoma, other high-grade sarcomas, or endometrial stromal sarcoma. 4. Other active malignancies within 2 years prior to enrollment, except for locally curable malignancies that have been cured, such as basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or breast carcinoma in situ. 5. Active autoimmune disease requiring systemic treatment within 2 years prior to initiation of study treatment, or any autoimmune disease judged by the investigator as likely to recur or requiring planned treatment. Exceptions include: skin diseases not requiring systemic therapy (e.g., vitiligo, alopecia, psoriasis, or eczema); hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; well-controlled type I diabetes; childhood asthma completely resolved in adulthood without any intervention; or diseases judged by the investigator as unlikely to recur in the absence of external triggers. 6. Active or clinically treated inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or chronic diarrhea. 7. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 9. Known history or presence of interstitial lung disease. 10. History of gastrointestinal perforation and/or fistula within 6 months prior to enrollment. 11. Presence of necrotic lesions identified within 4 weeks prior to enrollment, which in the investigator’s judgment pose a risk of major hemorrhage. 12. Serious infection within 4 weeks prior to the first dose, including, but not limited to, complications requiring hospitalization, sepsis, or severe pneumonia. 13. Known active tuberculosis (TB). Subjects suspected of having active TB must be evaluated with chest X-ray, sputum examination, and clinical signs/symptoms to rule out active infection. 14. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA >1000 IU/mL, and subjects with active hepatitis C are excluded. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B subjects (HBV DNA <1000 IU/mL), and cured hepatitis C subjects may be enrolled. Subjects positive for hepatitis C antibody (HCV Ab) are eligible only if HCV RNA test results are negative. 15. Known leptomeningeal metastasis, spinal cord compression, leptomeningeal disease, or active brain metastases. However, subjects with measurable lesions outside the central nervous system are eligible if they meet the following criteria: 1) Previously untreated and currently asymptomatic (e.g., no neurological dysfunction, seizures, or other typical signs/symptoms of CNS metastases; no glucocorticoid therapy required); 2) Asymptomatic after treatment, with radiologically sta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactLi Sun
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed