Gastric carcinoma
Conditions
Interventions
Group 1:catumaxomab
Group 2:The treatment of investigator choice
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent forms have been provided; 2. Willing to be complaint with the study procedures during the study; 3. Male or female, age18years old when signing informed consents; 4. Histologically or cytologically confirmed as gastricadeno carcinoma; 5. Evaluable and/or non-evaluable lesions according to RECISTV1.1 criteria; 6. Diagnosed as gastric cancer with peritoneal metastases (Imaging finding, previous surgicalpathology, ascites/peritoneal effusion cytology positive); 7. Treatment failure after receiving at least prior two standard systemic anti-cancer therapies for recurrent or metastatic gastric cancer; 8. Recovered from any toxicity due to previous treatment (Grade 0-1 according to NCI-CTCAEv5.0); 9. Estimated survival length >= 3 months; 10. Eastern Oncology Cooperative Group(ECOG) performance status 0-2; 11.Body mass index (after ascites drainage) >= 17 at screening 12.The laboratory test values during the screening period are in accordance with the followingtableANC(absolute neutrophil count >= 1.5x10^9/L, Hemoglobin >= 80 g/L, Platelet >= 100 x 10^9/L, Lymphocyte >= 0.8 x 10^9/L Serum Bilirubin = 30 mL/min. 13. For women of childbearing potential: use medically acceptable contraceptive measures(see Appendix 11.7) at least 1 month prior to screening and agree to use this method forcontraception from screening till 30 days after last peritoneal infusion.; 14. For men with fertility potential: use medically acceptable contraceptive measures for sexual partners from screening till 30 days after last peritoneal infusion.
Exclusion criteria
Exclusion criteria: 1. Known or suspected of being allergic to catumaxomab or similar antibodies; 2. Previously received anti-tumor treatments, including other anti-tumor investigational drugs, chemotherapy, immunotherapy, biological agents, hormone therapy, radiation therapy (except local radiation therapy for pain relief), etc., the interval between the last treatment and the first peritoneal infusionis = 50% of the total liver volume by imaging); 4. Known tumor in tra-cranial metastases; 5. The following diseases have not been resolved to CTCAE grade 0-1 3 days before the first infusion: (1) Uncontrolled acute and chronic infections such as pneumonia, biliary infection, COVID-19 infection,hepatitis B virus infection and hepatitis C virus infection,etc.; (2) Acute or chronic pancreatitis; (3) Infectious peritonitis. (4) Diarrhea; (5) Dyspnea; 6. NYHA Class 3 or 4; 7. Symptoms and signs of related cardiovascular diseases: including myocardial infarction, congestive heart failure,arrhythmia; 8. Known cerebrovascular accidents; 9. Intestinal obstruction occurred 30 days before the first dose; 10.Patients with peritoneal disorders, including but not limited to gastrointestinal adhesionor peritoneal cyst due to prior treatment, inflammation or infection; 11. Imaging diagnosis of portal vein or bile duct obstruction, including tumor compressionor portal thrombosis, cancer thrombus. 12. History of autoimmune diseases (e.g.,inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autologous hemolytic anemia, rheumatoid arthritis,etc.); 13. Patients with known HIV serology positive, hepatitis C infection and/or hepatitis B (Except the patients with HepBsAg or core antibody positive and responding to antiviral therapy against hepatitis B who are allowed to participate in the study; Notes: HepBsAg-negative patients at screening, or patients are undergoing treatment with interferon-2a [IFN] or peginterferon-2a [Peg-IFN] and hepatitis B virus [HBV] DNA < 2000 international units [IU], or subjects who are receiving nucleoside [acid] analogues at screening and HBV DNA below the lower limit of normal [LLN] are eligible to participate in the study); 14.Patients received COVID-19 vaccination from 30 days prior to ICF signed off to the endof study treatment. 15. Pregnancy or breast feeding during study treatment and follow-up; 16. Patients diagnosed as neurological or psychotic disease and require the treatment duringstudy period, including epilepsy or dementia. 17. Other serious systemic conditions that may limit the patient's participation in this study (eg uncontrolled diabetes, cardiovascular and cerebrovascular disease, severe gastrointestinal disease,etc.); 18. Any other condition that, in the discretion of the investigator will make patients exposed tounnecessary risks and unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;Progression free interval of peritoneal metastatic lesions;Objective Response Rate;Clinical Benefit Rate;Duration of Response;Ascites Remission Duration;The incidence and severity of treatment-emergent adverse events;Incidence of DLT;Pharmacokinetics parameters of intra-peritoneal infusion of catumaxomab in plasma.;The incidence of anti-drug antibodies (ADA) to catumaxomab in serum.;Tendency of the peripheral blood lymphocyte counts change associated with the intra-peritoneal infusion of catumaxomab.; | — |
Countries
China
Contacts
Public ContactLin Shen
Beijing Cancer Hospital
Outcome results
None listed