malignant ascites
Conditions
Interventions
Experimental group:Bevacizumab: 5mg/kg, intraperitoneal hyperthermic perfusion, once a week for 4 consecutive weeks
Sintilimab: 200mg, intravenous infusion, once every 2 weeks on day 1, for 4 consecut
Sponsors
Sichuan University West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with advanced malignant solid tumors confirmed by histology or cytology to be unresponsive to standard systemic therapy and accompanied by malignant ascites; 2. Aged >=18 years, male or female; 3. Estimated survival >=3 months; 4. No history of antitumor therapy or surgery within 4 weeks prior to enrollment; 5. ECOG behavioral status score 0-2,or KPS status score >= 60; 6. Blood routine examination: neutrophil absolute value >=1.5×10^9/L; hemoglobin >= 80g/L; blood platelet >= 80×10^9/L; 7. Liver renal function; BIL< 1.5 times the upper limit of normal value; ALT or AST< 2.5 times the upper limit of normal value; Scr < 2.5 times the upper limit of normal value; 8. No prior allergic reactions to biological agents; 9. Subjects fully understand the content of this study, sign informed consent, and be willing to accept follow-up.
Exclusion criteria
Exclusion criteria: 1. History of antineoplastic therapy or surgery within 4 weeks prior to enrollment; 2. Subjects who have complicated gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis and other gastrointestinal diseases that may lead to gastrointestinal bleeding or perforation; 3. Uncontrolled hypertension and active bleeding, hemoptysis or bloody ascites; 4. A blood clot or mental illness occurred within 12 months prior to enrollment; 5. Patients with pregnancy or lactation; 6. Subjects requiring systemic treatment with corticosteroids (>10 mg/day equivalent of prednisone) or other immunosuppressive agents within 14 days prior to use of PD-1 mab. Each of the following except: (1) In the absence of active autoimmune disease, inhaled, ophthalmic, or topical steroids and adrenocorticosteroids at doses not exceeding the therapeutic dose of prednisone 10 mg/day are permitted; (2) Physiological doses of systemic glucocorticoids not exceeding 10mg/d of prednisone or equivalent doses of other glucocorticoids; (3) Glucocorticoid as a prophylactic drug for hypersensitivity( Such as medication before CT examination and pretreatment before chemotherapy); 7. Infection occurred within 28 days prior to use of PD-1 mab, including, but not limited to, complications requiring hospitalization, sepsis, or severe pneumonia; 8.There is a active infection requiring systemic treatment prior to use of PD-1 mab, except for local infections requiring only local antibiotics, such as skin infections; 9. Received live or attenuated vaccine within 30 days prior to use of PD-1 mab, or planned to receive vaccine during the study period; 10. There is a known history of primary immunodeficiency virus infection; 11. There is a known history of active tuberculosis (TB).Subjects who are suspected of active TB,need to be checked the chest computed tomography (CT) or x-rays, sputum and excluded by a clinical signs and symptoms; 12. There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 13. Have an active, known or suspected autoimmune disease, or a history of autoimmune disease; 14. Patients who were assessed by the investigator to be at unnecessary risk for treatment under the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;overall survival;progression-free survival;incidence and severity of adverse events;changes in quality of life;ascites and peripheral blood biomarkers, and immune microenvironment; | — |
Countries
China
Contacts
Public ContactMa Ji
Sichuan University West China Hospital
Outcome results
None listed