NCT04222114

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2020

Typical duration for phase_3

Geographic Reach
3 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

October 6, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2.5 years

First QC Date

January 5, 2020

Last Update Submit

January 29, 2023

Conditions

Stomach Neoplasms

Keywords

Stomach NeoplasmsPeritoneal metastasiscatumaxomab

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    Defined as the time from randomization to death for anyreason.

    1 year

Secondary Outcomes (10)

  • Progression Free Survival (PFS)

    1 year

  • Progression free interval of peritoneal metastatic lesions

    1 year

  • Objective Response Rate (ORR)

    1 year

  • Clinical Benefit Rate(CBR)

    1 year

  • Duration of Response (DoR)

    1 year

  • +5 more secondary outcomes

Study Arms (2)

Catumaxomab group

EXPERIMENTAL
Drug: Catumaxomab

IC group

ACTIVE COMPARATOR

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.

Drug: The treatment of investigator choice

Interventions

CatumaxomabDRUG

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.

Catumaxomab group
The treatment of investigator choiceDRUG

the localized supportive treatment which has been approved or recommended by local gastric cancer guidance to treat the peritoneal metastasis.

IC group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated informed consent forms have been provided.
  • Willing to be complaint with the study procedures during the study.
  • Male or female, age≥18years old when signing informed consents.
  • Histologically or cytologically confirmed as gastricadeno carcinoma.
  • Evaluable and/or non-evaluable lesions according to RECISTV1.1 criteria.
  • Diagnosed as gastric cancer with peritoneal metastases (Imaging finding, previous surgicalpathology, ascites/peritoneal effusion cytology positive).
  • Treatment failure after receiving at least prior two standard systemic anti-cancer therapies for recurrent or metastatic gastric cancer.
  • Recovered from any toxicity due to previous treatment (Grade 0-1 according to NCI-CTCAEv5.0).
  • Estimated survival length≥3months.
  • Eastern Oncology Cooperative Group(ECOG) performance status 0-2.
  • 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).
  • 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.
  • For men with fertility potential: use condoms or other methods to ensure effective contraception for sexual partners.

You may not qualify if:

  • Known or suspected of being allergic to catumaxomab or similar antibodies.
  • 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.
  • There is extensive liver metastasis(the tumor volume is estimated to be≥50% of the total liver volume by imaging).
  • Known tumor in tra-cranial metastases.
  • 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
  • NYHA Class 3 or 4.
  • Symptoms and signs of related cardiovascular diseases: including myocardial infarction, congestive heart failure,arrhythmia.
  • Known cerebrovascular accidents.
  • Intestinal obstruction occurred 30 days before the first dose.
  • Imaging diagnosis of portal vein obstruction, including tumor compression or portal thrombosis,cancer thrombus.
  • History of autoimmune diseases (e.g.,inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autologous hemolytic anemia, rheumatoid arthritis,etc.).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

The First Bethune Hospital of Jilin University.

Jilin, Jilin, 130000, China

RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

RECRUITING

Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 800, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Chi Mei Hospital, Liouying

Tainan, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

catumaxomab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 9, 2020

Study Start

October 6, 2020

Primary Completion

March 31, 2023

Study Completion

August 31, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

CN(5)KR(4)TW(4)