ovarian cancer
Conditions
Interventions
treatment group:QL1706+Nab-paclitaxel+Bevacizumab
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with pathological types including: high-grade serous adenocarcinoma, endometrioid carcinoma (G2 or G3), clear cell carcinoma, etc.; 3. Platinum-resistant recurrent ovarian cancer patients who have received platinum-based therapy and experienced disease progression during platinum-based therapy (platinum-refractory) or within =2 times the upper limit of normal [ULN], requiring confirmation after 1 week) accompanied by clinical symptoms or physical examination suggesting disease progression; 4. Progressed during or after the most recent line of systemic therapy, or intolerable to treatment, with at least one measurable lesion (assessed by the investigator according to RECIST 1.1); 5. ECOG Performance Status score of 0 or 1 within 7 days before the first dose; 6. >=3 weeks from the end of prior chemotherapy to the first dose in this study; >=4 weeks from the end of monoclonal antibody anti-cancer therapy to the first dose; >=2 weeks from the end of small molecule targeted therapy to the first dose; 7. Treatment-related adverse events have recovered to NCI-CTCAE grade =1 (except grade 2 alopecia); 8. Subjects must have adequate organ function, meeting all the following laboratory results before enrollment: a) Bone marrow reserve (no transfusion or blood products, no G-CSF or other hematopoietic growth factors for correction within 7 days before screening): Absolute neutrophil count >=1.5 × 10^9/L, Hemoglobin >=90 g/L, Platelets >=100 × 10^9/L; b) Liver function: Total bilirubin = 60 mL/min; d) Coagulation function: INR =12 weeks; 10. For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception with a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose (whichever is later).
Exclusion criteria
Exclusion criteria: 1. Received >1 line of systemic therapy for ovarian cancer after developing platinum resistance, and/or received >1 line of non-platinum systemic therapy before platinum resistance; 2. Subjects who progressed during the first platinum-based chemotherapy (from first dose to 28 days after the last dose); 3. Tumors of low malignant potential (e.g., low-grade serous adenocarcinoma, endometrioid carcinoma G1), borderline tumors, ovarian mucinous carcinoma, non-epithelial tumors (e.g., sex cord-stromal tumors, germ cell tumors, carcinosarcoma); 4. Other active malignancies within 5 years or concurrently (cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc., may be enrolled); 5. Received any pelvic or abdominal radiotherapy; 6. Positive for human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive with HBV-DNA = lower limit of detection of the central laboratory), or hepatitis C virus infection (HCV antibody positive with HCV-RNA >= lower limit of detection of the central laboratory); 7. Patients at risk for active autoimmune diseases, or with a history of autoimmune diseases that may involve the central nervous system, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain–Barré syndrome), etc. Exceptions: Type I diabetes, hypothyroidism stable on hormone replacement therapy (including that caused by autoimmune thyroid disease), psoriasis or vitiligo not requiring systemic treatment, autoimmune diseases caused by B cells or autoantibodies; 8. Lung disease defined as >= Grade 3 per NCI-CTCAE v5.0; patients with current or history of interstitial lung disease (ILD); 9. Patients who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation; 10. Patients who have recently undergone major surgery or are expected to undergo surgical treatment: a) Major surgery or significant trauma within 28 days before enrollment; b) Planned major surgery during the study, including but not limited to abdominal surgery (open or laparoscopic) before disease progression; c) Open biopsy within 7 days before enrollment; 11. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); clinically significant bleeding events, arterial or deep venous thromboembolic events within 6 months before enrollment, or superficial venous thrombosis and intermuscular venous thrombosis requiring intervention; 12. Currently taking or recently (within 10 days before the first dose) taken aspirin (>325 mg/day) or other non-steroidal anti-inflammatory drugs that may affect platelet function; 13. History of intestinal obstruction (including incomplete intestinal obstruction) within 3 months before enrollment; history of abdominal fistula, gastrointestinal perforation, or abdominal abscess; 14. Severe infection during the screening period requiring systemic intravenous antibiotics or hospitalization; 15. Clinically manifest central nervous system (CNS) diseases, or brain metastases; history of stroke (CVA) or trans
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective relief rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS;Disease control rate, DCR;Quality of Life Endpoints;Immunogenicity Assessment;Incidence of Adverse Events and Serious Adverse Events ; | — |
Countries
China
Contacts
Public ContactXuejun Chen
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed