A total of 297 subjects are estimated to enroll in the study, with 15 eligible subjects enrolled in the 1st stage at most and 282 evaluable subjects in the 2nd stage. All subjects are adult patients with age over 18-year-old; they must be diagnosed with recurrent or metastatic gastric cancer with peritoneal metastasis at the time of enrollment; and failed at least prior two standard systemic anti-cancer therapies for recurrent or metastatic gastric cancer, before enrollment. In the first stage, pharmacokinetic characteristics and preliminary safety of catumaxomab will be explored in Asian patients with gastric cancer ; in Cohort A, the enrolled subjects will receive the first infusion at 10μg on day 1, which will be increased to 20 μg, 50 μg and 150 μg on days 4, 8 and 11, respectively. 42 days are defined as a cycle. From the second cycle, catumaxomab will be changed to 20 μg, 50 μg, 150 μg on days 1, 4, 8 respectively. In Cohort B, 28 days are defined as a cycle. It is estimated to enroll 6 subjects in each cohort first. In the second stage, approximate 282 subjects who meet the enrollment criteria are randomized into either catumaxomab infusion group (catumaxomab group) or treatment of investigator choice group (IC group), at a ratio of 2:1. Subjects at the first and second stages will continue the treatment until one of the following conditions occurs:1)Significant progression of tumor lesions, including but not limited to peritoneal metastases lesions and/or ascites; 2)Intolerable toxicity; 3)The investigator believes that patients need to withdraw from the study and receive other treatment;4)death;5)Withdrawal of informed consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
282
The starting dose of catumaxomab for intra-peritoneal infusion will be 10μg, gradually increased to 20μg, 50μg and 150μg, respectively. From the second cycle, catumaxomab will be changed to 20μg,50μg,150μg on days 1,4 and 8.
the localized supportive treatment which has been approved or recommended by local gastric cancer guidance to treat the peritoneal metastasis.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Bethune Hospital of Jilin University.
Jilin City, Jilin, China
RECRUITINGAjou University Hospital
Suwon, Gyeonggi-do, South Korea
RECRUITINGGangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGThe Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
RECRUITINGKaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
RECRUITING...and 3 more locations
Overall survival (OS)
Defined as the time from randomization to death for anyreason.
Time frame: 1 year
Progression Free Survival (PFS)
According to RECIST V1.1 criteria, defined as the timefrom randomization to progression disease (PD) or death for any reason,which ever occurs first.
Time frame: 1 year
Progression free interval of peritoneal metastatic lesions
to subjects with ≥300 ml of ascites, defined as the time from first intra-peritoneal infusion to ascites progression based on the five--point method2; to subjects without ascites or \<300 ml, it is defined as the time from the first intra-peritoneal infusion to thetimeof progression oftheintra-peritoneal lesion according to theRECISTV1.1 criteria.
Time frame: 1 year
Objective Response Rate (ORR)
According to RECIST V1.1 criteria, defined as the proportion of subjects with response achieving CR or PR;
Time frame: 1 year
Clinical Benefit Rate(CBR)
According to RECIST V1.1 criteria,defined as the proportion of subjects with response achieving SD,PR or CR;
Time frame: 1 year
Duration of Response (DoR)
According to RECIST V1.1 criteria, defined as the time from the response to the confirmation of PD
Time frame: 1 year
Ascites Remission Duration
Defined as the time from the 1st as cites remission to as cites progression,according to the five-point method.
Time frame: 1 year
The incidence and severity of treatment-emergent adverse events (TEAEs) in the catumaxomab and IC groups
Compared according to the National Cancer Institute Common Terminology Standard for Adverse Events (NCI-CTCAE)v5.0.
Time frame: 1 year
Incidence of DLT
it will be evaluated in the first stage only. It is defined as the incidence of DLT from the first infusion to 6 weeks after wards.
Time frame: 1 year
The incidence of anti-drug antibodies(ADA) to catumaxomab in serum
The incidence of anti-drug antibodies(ADA) to catumaxomab in serum
Time frame: 1 year
Tendency of theperipheral blood lymphocyte counts change associated with the intra-peritoneal infusion of catumaxomab
Tendency of theperipheral blood lymphocyte counts change associated with the intra-peritoneal infusion of catumaxomab
Time frame: 1 year
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