Comparing the Efficacy and Safety of Intra-peritoneal Infusion of Catumaxomab and Treatment of Investigator Choice in Patients With Advanced Gastric Carcinoma With Peritoneal Metastasis
NCT ID: NCT04222114
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
282 participants
INTERVENTIONAL
2020-10-06
2023-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Catumaxomab group
Catumaxomab
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.
IC group
IC group is defined as the localized supportive treatment which has been approved or recommended by local gastric cancer guidance to treat the peritoneal metastasis.
The treatment of investigator choice
the localized supportive treatment which has been approved or recommended by local gastric cancer guidance to treat the peritoneal metastasis.
Interventions
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Catumaxomab
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 treatment of investigator choice
the localized supportive treatment which has been approved or recommended by local gastric cancer guidance to treat the peritoneal metastasis.
Eligibility Criteria
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Inclusion Criteria
2. Willing to be complaint with the study procedures during the study.
3. Male or female, age≥18years 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≥3months.
10. Eastern Oncology Cooperative Group(ECOG) performance status 0-2.
11. The laboratory test values during the screening period are in accordance with the following table：ANC(absolute neutrophil count)≥ 1.5 × 10\^9/L， Hemoglobin≥ 80 g/L，Platelet≥ 100 × 10\^9/L， Lymphocyte percentage≥13%，Serum Bilirubin≤ 1.25 x ULN(or 2.5 x ULN if there is Gilbert)， AST and ALT ≤ 2.5 × ULN without liver metastasis（or≤ 5 × ULN if liver metastasis ），Serum creatinine ≤ 2.0 mg/dL (or Calculated creatinine clearance≥30 mL/min).
12. For women of childbearing potential: use an efficient method for contraception at least 1 month prior to screening and agree to use this method for contraception during the study period and extended period specified after the study intervention.
13. For men with fertility potential: use condoms or other methods to ensure effective contraception for sexual partners.
Exclusion Criteria
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 infusion is ≤ 21days.
3. There is extensive liver metastasis(the tumor volume is estimated to be≥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:
* Uncontrolled acute and chronic infections such as pneumonia, biliary infection, hepatitis B virus infection and hepatitis C virus infection,etc.;
* Acute or chronic pancreatitis;
* Diarrhea;
* 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. Imaging diagnosis of portal vein obstruction, including tumor compression or portal thrombosis,cancer thrombus.
11. History of autoimmune diseases (e.g.,inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autologous hemolytic anemia, rheumatoid arthritis,etc.).
12. 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).
13. Pregnancy or breast feeding during study treatment and follow-up.
14. Patients with confirmed history of neurological or psychotic disorders, including epilepsy or dementia.
15. 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.).
16. Any other condition that, in the discretion of the investigator will make patients exposed to unnecessary risks and unsuitable for participation in this clinical study.
18 Years
ALL
No
Sponsors
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LintonPharm Co.,Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Bethune Hospital of Jilin University.
Jilin, Jilin, China
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chi Mei Hospital, Liouying
Tainan City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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Facility Contacts
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Other Identifiers
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LP0190415
Identifier Type: -
Identifier Source: org_study_id
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