Ovarian cancer, tubal cancer and primary peritoneal adenocarcinoma
Conditions
Interventions
single arm: sintilimab combined with capecitabine
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Epithelial ovarian cancer, tubal cancer, or primary peritoneal cancer were histologically confirmed.The types are: non-specific adenocarcinoma, clear cell carcinoma, endometrioid adenocarcinoma, malignant Brenner tumor, mixed epithelial carcinoma, mucinous adenocarcinoma, serous adenocarcinoma, transitional cell carcinoma and undifferentiated carcinoma; 3. At least one measurable tumor lesion (RECIST1.1); 4. ECOG score 0-2; 5. Subjects must have appropriate organ function and conform to the following laboratory test results before enrollment: (1) Bone marrow reserve is basically normal: ANC>=1.5x10^9/L, HB>=80 g/L, PLT>=80x10^9/L; (2) Liver function was basically normal: TBIL=50mL/min; 6. Disease progression occurred within 6 months after completion of platinum containing regimen and >=third-line chemotherapy; 7. Expected survival time >=12 weeks; 8. At least 4 weeks from the last chemotherapy, and elution of at least 4 half-life periods is required if you have received anti-tumor biological products; 9. The toxic and side effects caused by previous treatment should be restored to = level 1 (CTCAE5.0); 10. Subjects shall give informed consent to the study prior to the study and voluntarily sign written informed consent; 11. The subject can have good communication with the researcher and complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: 1. ECOG score >=3; 2. Ovarian tumors with low malignant potential, such as borderline tumors; 3. Patients with other invasive malignant tumors or previous malignant tumors are contraindicated in the current treatment plan; 4. Presence of a serious or uncontrolled systemic disease (such as severe mental or neurological disease, epilepsy or dementia, unstable or unremunerated respiratory, cardiovascular, liver or kidney disease, severe infection, uncontrolled hypertension, diabetes, active bleeding); 5. Inability to take or take medicine orally for any reason, such as intestinal obstruction; 6. Untreated infected persons with acute or chronic active hepatitis B or C.Patients receiving antiviral treatment are monitored for virus copy number, and doctors determine eligibility based on individual patient conditions. 7. Allergic to capecitabine or 5-Fu or sindilumab; 8. The patient had received previous immunotherapy, such as PD-1 antibody, PD-L1 antibody, CTLA4 antibody, etc. 9. Receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period; 10. Active, known or suspected autoimmune diseases; 11. Hypothyroidism; 12. A history of primary immunodeficiency is known; 13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 14. always used immunosuppressive drugs within 4 weeks, not including the nasal spray, inhalation, or other ways of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day prednisone or other equivalent dose glucocorticoids), allowing for treatment of diseases such as asthma, chronic obstructive pulmonary disease, breathing difficulties for the temporary use of glucocorticoid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease median response time;Disease Control Rate;progression free survival;overall survival;serious adverse event;Immune-related adverse events; | — |
Countries
China
Contacts
Public ContactWu Rong
Mianyang Central Hospital
Outcome results
None listed