Malignant ascites
Conditions
Interventions
Case series:An appropriate dose of M701 via intraperitoneal injection once a week for 4 consecutive weeks
Sponsors
the 307th Hospital of People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men or women, aged 18 to 75 years; 2. Histologically or cytologically confirmed advanced solid tumors; 3. Clinical diagnosis of malignant ascites and need for ascites puncture; 4. Standard treatment failure, or no standard treatment, or patient rejection of standard treatment; 5. Patients who have received anti-tumor therapy including chemotherapy, immunotherapy, biological agents, hormone therapy, radiotherapy (except local radiotherapy for pain relief) >= 4 weeks prior to the screening period; 6. Patients who have recovered from any toxic reaction to previous medications (Grade 0 or1 based on NCI-CTCAE v4.03); 7. Patients with an ECOG Performance Status score (PS) 0-3; 8. Patients with a life expectancy > 8 weeks; 9. Organ function levels must meet the following requirements: Blood phase: absolute neutrophil count (ANC) >= 1.5*10^9/L, platelet count >= 80*10^9/L, hemoglobin >= 9.0 g/dL (without blood transfusion within14 days before the first dose of study drug); Liver: bilirubin <= 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) <= 3 x ULN ( <= 5 x ULN in case of liver metastases); Kidney: serum creatinine <= 1.5 x ULN; 10. Patients must understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known to have a history of allergy to the active ingredients of M701; or with a definite history of drug allergy or specific allergy (asthma, rubella, eczema dermatitis); 2. Previously received similar monoclonal antibodies within 4 months prior to the enrollment; 3. Extensive liver metastases (> 70%); 4. Uncontrolled active infection (CTCAE >= Grade 2); 5. Serious diarrhoea (CTCAE >= Grade 2); 6. Serious dyspnoea requiring oxygen therapy; 7. History of auto-immune diseases (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, serious psoriasis, rheumatoid arthritis); 8. History of acute or chronic pancreatitis; 9. Other serious diseases that may prevent patient's participation in this trial (such as uncontrolled diabetes mellitus, severe gastrointestinal disorders, etc.); 10. Insufficiency cardiac, NYHA class III or IV; 11. Intestinal full obstruction that occurred within 30 days prior to the first dose of study drug, or intestinal partial obstruction but the investigator considers it is not suitable to participate in the trial according to the symptoms and signs; 12. Abdominal adhesions, septa formation or encapsulated effusion, etc., with non-drainable ascites; 13. Confirmed portal vein obstruction; 14. History of immunodeficiency, including positive HIV test; 15. Active hepatitis B virus infection (HBV DNA >= 1*10'4 copies/mL or 2000 IU/mL) or positive in either HCV, or HIV, or syphilis antibody tests; 16. Pregnant or breastfeeding woman; 17. Plan to conceive within a half year; 18. Previous confirmed history of neurological or mental disorders, including epilepsy and dementia; 19. Have received a clinical study active drug treatment within 1 month prior to the study; 20. Are deemed ineligible for this clinical trial by study personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD;DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Parameters;PD Measures: Tumor markers; Cytokines; Counts of lymphocytes, monocytes, and granulocytes; Lymphocyte subsets;Index of the efficacy of Ascites;Index of the efficacy of Tumor;Immunogenicity; | — |
Countries
China
Contacts
Public ContactXu Jianming, Wang Shixuan
307th Hospital of People's Liberation Army
Outcome results
None listed