Ovarian cancer
Conditions
Interventions
Trial group:The subjects received high-dose radiotherapy combined with immunotherapy, of which high-dose radiotherapy was used for the primary measurable lesion. The specific dose and range were PGTV1
Sponsors
Yichun People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years; 2. Confirmed diagnosis of ovarian cancer by histology or cytology; 3. FIGO stage III-IV; 4. Failure of at least one prior line of standard chemotherapy, regardless of prior immunotherapy; 5. At least two measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (excluding ascites, pleural effusion, etc.); 6. ECOG performance status =55% as assessed by echocardiography; (2) Hematological parameters: white blood cell count >=3.0×10^9/L, hemoglobin >=90 g/L, absolute neutrophil count >=1.5×10^9/L, platelet count >=75×10^9/L; (3) Hepatic and renal function: total bilirubin =28 g/L, serum creatinine <=1.5×ULN; (4) Urinalysis: urine protein <2+; (5) Coagulation function: international normalized ratio (INR) <=1.5×ULN; activated partial thromboplastin time (APTT) <=1.5×ULN; 9. Understanding and voluntary written informed consent signed, as judged by the investigator to be able to comply with the study protocol; 10. Other conditions deemed potentially beneficial by the investigator.
Exclusion criteria
Exclusion criteria: 1. Evidence of interstitial lung disease or active, non-infectious pneumonia; 2. Severe inadequacy of cardiac, hepatic, or renal function; 3. Severe, uncontrolled psychiatric symptoms; 4. Imaging shows tumor invasion of critical vessels, or the investigator judges that the patient has a very high likelihood of invading critical vessels during tumor treatment, leading to fatal hemorrhage; 5. Use of systemic corticosteroids or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 4 weeks prior to enrollment, or anticipated need for other systemic immunosuppressive agents during the trial. Subjects with active, known, or suspected autoimmune diseases, such as interstitial pneumonia, uveitis, Crohn’s disease, or autoimmune thyroiditis, are excluded. Type I diabetes requiring only hormone replacement therapy is acceptable; 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Uncontrolled comorbidities, including but not limited to: (1) Active or poorly controlled severe infection; (2) Human immunodeficiency virus (HIV) infection (HIV antibody positive); (3) Known acute or chronic active hepatitis B (HBV DNA positive) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive); (4) Active tuberculosis; (5) Symptomatic congestive heart failure (New York Heart Association class III–IV) or uncontrolled symptomatic arrhythmias; (6) Uncontrolled hypertension (SBP =160 mmHg or DBP =100 mmHg); (7) Prior arterial thromboembolic events, including myocardial infarction, unstable angina, stroke, or transient ischemic attack, occurring within 6 months prior to enrollment with concomitant need for anticoagulation therapy; (8) Uncontrolled hypercalcemia (Ca²? >1.5 mmol/L or Ca >12 mg/dL or corrected serum calcium >ULN), or symptomatic hypercalcemia during bisphosphonate therapy; 9. Other primary malignancies, except for cured non-melanoma skin cancer or cured cervical carcinoma in situ; 10. According to the investigator’s judgment, subjects with other diseases or abnormal laboratory findings that may increase the risk of enrollment and treatment or interfere with interpretation of study results may be excluded; 11. Pregnant or lactating women; 12. Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival;Disease Control Rate;Duration of Response;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactAI Sufen
Jiangxi Yichun People's Hospital
Outcome results
None listed