Peritoneal Carcitnomatosis
Conditions
Interventions
Cases:SCB-313 lyophilized powder needs to be reconstituted before usage. In the dose escalation phase, the designated dose of SCB-313 will be injected once per 3 days in the peritoneal cavity for 3 co
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand and voluntarily sign written informed consent; 2. Male or female subjects aged 18 to 75 years. 3. Confirmed by histopathology or cytopathology, any primary or secondary malignant peritoneal carcitomatosis subject; 4. Progression after standard treatment, or inability to tolerate standard treatment, or no standard treatment; 5. ECOG status 0 to 2 or KPS status > 60; 6. CT-PCI (Peritoneal Carcinomatosis Index) status >= 15; 7. Life expectancy of at least 3 months; 8. No serious hematologic, hepatic, renal dysfunction, comply with the following laboratory test results: 1) Hematology: white blood cell count >3*10^9/L, absolute neutrophil count >= 1.5*10^9/L, platelets > 75*10^9/L, hemoglobin > 90 g/L; 2) Liver function: aspartate aminotransferase and alanine aminotransferase = 50 mL/min; 9. All adverse events from previous system anticancer treatment return to baseline or <= grade 1 (except for alopecia and vitiligo, neuropathy which induced by previous anticancer therapy status stable or <= grade 2); 10. Male or female subjects undergo effective contraception during treatment and within 6 months after last dose.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with TRAIL pathway drug. 2. Malignant carcitomatosis diseases other than malignant peritoneal cancer in this study (Exceptions include: a cured malignant cancer without relapse within 3 years prior to the study enrollment, completely resected basal cells and squamous cell skin cancer, and any type of carcinoma in situ). 3. Primary lesion invades the central nervous system (CNS) with symptoms develop, status unstable or require high dose steroids (e.g. dexamethasone >=10 mg or equivalent dose) to control. 4. Abnormal HBV examination, anti-HCV positive, anti-HIV antibody positive or other serious infections requiring systemic treatment within 4 weeks prior to first dosing (e.g. virus, bacteria or fungus). 5. Use the following concomitant therapy before dosing: 1) Use drug that prolongs the QT interval and/or associated with the risk of torsades de pointes ventricular tachycardia (TdP) within 7 days prior to first dosing. 2) Use amiodarone within 90 days prior to first dosing. 6. Impaired heart function or clinically significant cardiovascular disease, including any of the following: 1) Cerebrovascular accident/stroke (within 6 months prior to enrollment). 2) Myocardial infarction (within 6 months prior to enrollment). 3) Unstable angina, congestive heart failure (New York Heart Association grade >= II) or severe arrhythmia requiring medication (including QT/QTc interval extension >480 msec, installation of pacemakers, etc.). 4) Left ventricular ejection fraction = grade 2. 10. Known to have alcohol and/or drug dependence. 11. Previous clear history of neurological or mental disorders, such as epilepsy, poor compliance 12. Female subjects with positive blood pregnancy tests or during lactation. 13. Previously allergic to macromolecular protein drugs or proteins or Quinckes edema (Kunke edema, also known as angioedema) or allergic to any component of the SCB 313. 14. Known history of infection with human immunodeficiency virus, or other acquired, innate immune deficiency diseases, or history of organ transplantation. 15. Vaccination within <= 4 weeks prior to first dosing, or planning live vaccination. 16. For other reasons according to investigators, not suitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Adverse event; | — |
Countries
China
Contacts
Public ContactYan li, Xinghe Wang
Beijing Shijitan Hospital, Capital Medical University Medical
Outcome results
None listed