Endometrial Cancer
Conditions
Interventions
Intervention group:The first stage of treatment is:
QL1706 5 mg/kg IV Q3W Carboplatin AUC 5 IV Q3W Paclitaxel 175 mg/m2 IV Q3W for a total of 6 cycles
The second stage of treatment is:
QL1706 5 mg/kg
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in the study and sign the informed consent form; 2. Age over 18 years old (including 18 years old), under 80 years old (including 80 years old), female; 3. Expected survival >=12 weeks; 4. Eastern Cooperative Oncology Group (ECOG) physical status of 0 - 2 points within 7 days before the first dose of study drug; 5. Have a clear histopathological diagnosis of endometrial carcinoma (endometrioid adenocarcinoma, serous carcinoma, clear cell carcinoma, carcinosarcoma) and have immunohistochemistry reports with clear pMMR status; 6. Patients with stage III/IVa endometrial cancer with measurable lesions or measurable/non-measurable stage IVb patients or patients with recurrent endometrial cancer (measurable lesions refer to RECIST v1.1 criteria); 7. Patients can provide peripheral blood and tumor tissue before the first dose and after 3 cycles of treatment under the conditions allowed by the study physician (only peripheral blood and body fluids can be provided if there are no measurable lesions or tumor tissue cannot be obtained/assessed for greater risk). 8. Patients with primary endometrial cancer who have not received systemic therapy, including chemotherapy, immunotherapy, hormone therapy, or intraperitoneal hyperthermic chemotherapy (HIPEC) (including neoadjuvant therapy for endometrial cancer); 9. Patients with relapse who have received first-line systemic anticancer therapy (chemotherapy or targeted therapy) in the past, (patients who have progressed on PD-1 lenvatinib and/or high-dose progesterone therapy and long-term endocrine therapy can be accepted), and the last chemotherapy time is more than 6 months; 10. Female subjects of childbearing age must be non-lactating; 11. The physical condition has recovered after surgery (no serious complications related to surgery and contraindications to radiotherapy and chemotherapy) when receiving study treatment; 12. Adequate organ function; (1) Routine blood tests: (no blood transfusion within 14 days prior to screening, no use of granulocyte colony-stimulating factor [G-CSF], no medication correction): 1) Neutrophils>=1.5×10^9/L; 2) Platelets>=75×10^9/L; 3) Hemoglobin >=90g/L; (2) Biochemical examination: (no albumin transfusion within 14 days prior to screening): 1) Serum creatinine 50mL/min; 2) Serum total bilirubin =1.5×ULN (subjects with Gilbert's syndrome are allowed to have total bilirubin =50%; 13. Patients with active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be < 500 IU/mL (or <2500 copy/ml if the study center only has copy/mL testing units) and is willing to receive antiviral therapy throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA)-positive patients must receive antiviral therapy according to local standard treatment guidelines and have liver function within CTCAE grade 1 elevation; 14. Patients must have an ad
Exclusion criteria
Exclusion criteria: 1. Patients with no measurable lesions in stage III and IVa (RESICT v1.1); 2. Participating in other interventional clinical studies; 3. History of a second malignancy, unless potentially curative therapy has been completed and no signs of malignancy within 3 years. Note: The time requirement does not apply to participants who have successfully undergone definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other carcinoma in situ; 4. Previously received dual drug therapy with anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), anti-programmed cell death receptor ligand 2 (PD-L2) drugs combined with other stimulatory or synergistic inhibitory T cell receptors (such as cytotoxic T lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137); 5. Received a live vaccine within 30 days prior to receiving the first dose of study intervention. Note: Inactivated vaccines are allowed; 6. Is participating in or has participated in an investigational drug study, or has used an investigational device, within 4 weeks prior to the first dose of study intervention. Note: Participants who have entered the follow-up phase of a study may participate in the study as long as it has been 4 weeks since the last dose of study drug; 7. Contraindications to the use of carboplatin or paclitaxel; 8. Confirmed immunodeficiency or is receiving chronic systemic steroid therapy (at doses greater than 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention; 9. Severe allergy (grade >=3) to epalolitoroworelimab (QL1706) and/or any of its excipients; 10. Active autoimmune disease or history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who can only be controlled by hormone replacement therapy can be included]); Subjects with skin diseases such as vitiligo, psoriasis, alopecia, controlled type I diabetes mellitus treated with insulin or asthma in childhood who have been completely resolved without any intervention in adulthood can be included; Asthma patients requiring medical intervention with bronchodilators cannot be included; 11. Subjects with current interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis, organizing pneumonitis (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonitis, or evidence of active pneumonitis or severely impaired lung function on chest computed tomography (CT) chart at the screening period, active tuberculosis; 12. Has an active infection requiring systemic treatment; 13. Known history of HIV infection; 14. Patients who are ready for or have previously received organ or allogeneic bone marrow transplantation; 15. Not adequately recovered from surgery and/or surgical complications; 16. Breastfeeding; 17. History of gastrointestinal bleeding or clear tendency to gastrointestinal bleeding within 6 months before the start of study treatment, such as: bleeding risk or severe esophagogastric varices, local active gastrointestinal ulcer lesions, and persistent positive fecal occult bloo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Duration of response (DOR);Overall survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactYu Aijun; Xing Jie
Zhejiang Cancer Hospital
Outcome results
None listed