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Stomach NeoplasmsPhase 3NCT04222114

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

A Phase 3 study testing Catumaxomab and The treatment of investigator choice in people with Stomach Neoplasms, run by LintonPharm Co.,Ltd. at 13 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stomach Neoplasms
What is being tested?
Catumaxomab and The treatment of investigator choice
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
13 sitesin 3 countries
Study dates
6 Oct 2020to 31 Aug 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.;
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  • 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.).
  • 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).
  • Pregnancy or breast feeding during study treatment and follow-up.
  • Patients with confirmed history of neurological or psychotic disorders, including epilepsy or dementia.
  • 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.).
  • 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.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

China5 sites, 5 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lei Zhang, 010-88196861, zlei090903@163.com

    Lin Shen

    Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100142

    Li Ma, 010-66119025, bdyyec@163.com

    Shikai Wu

    Recruiting

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    ying lin, 020-87330631, zsyyicc2020@mail.sysu.edu.cn

    Shirong Cai

    Recruiting

  • The First Bethune Hospital of Jilin University.

    Jilin City, Jilin, 130000

    Liyuan Zhao, 0431-88782013, kjkzhaoliyuan@126.com

    wei Li

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Huiling Li, (0371) 6558 8251, 13937176523@163.com

    Jufeng Wang

    Recruiting

Other trials in China

South Korea4 sites, 4 recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul

    NA NA, +82-31-219-5569/4061/4062, ougi96@aumc.ac.kr

    Hei-Cheul Jeung

    Recruiting

  • Samsung Medical Center

    Seoul

    In Cho Hyun, +82-2-3410-1710, hyunin.cho@samsung.com

    Kim Seung Tae

    Recruiting

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

    Seoul

    Min Mina, +82-2-2258-8194, seoul_irb@catholic.ac.kr

    In-Ho Kim

    Recruiting

  • Ajou University Hospital

    Suwon, Gyeonggi-do

    NA NA, +82-02-2019-4601-3, gsirb@yuhs.ac

    Yong Won Choi

    Recruiting

Other trials in South Korea

Taiwan4 sites, 4 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 800

    NA NA, 886-7-3121101, irb-app@kmuh.org.tw

    Jaw-Yuan Wang

    Recruiting

  • China Medical University Hospital

    Taichung

    NA NA, +886-04-22052121#1941, rrec@mail.cmu.edu.tw

    Li-Yuan Bai

    Recruiting

  • Chi Mei Hospital, Liouying

    Tainan

    NA NA, +886-06-281281#53720, csr2930@mail.chimei.org.tw

    Cheng-Yao Lin

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Yeh Jung, +886-6-2353535 ext 4826, n993406@mail.hosp.ncku.edu.tw

    Chia-Jui Yen

    Recruiting

Other trials in Taiwan

About this study

Official title: A Two-stage,Multi-center,Open-label, Randomized,Controlled Trial 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

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.

Read more

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.

Being tested
Catumaxomab, The treatment of investigator choice
Keywords
Stomach Neoplasms, Peritoneal metastasis, catumaxomab
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04222114
Study groupRoleWhat they receive
Catumaxomab groupExperimentalNot described
Receives: Drug: Catumaxomab
IC groupActive comparatorIC group is defined as the localized supportive treatment which has been approved or recommended by local gastric cancer guidance to treat the peritoneal metastasis.
Receives: Drug: The treatment of investigator choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Defined as the time from randomization to death for anyreason.

    Measured: 1 year

Secondary outcomes (10)

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. Objective Response Rate (ORR)

    According to RECIST V1.1 criteria, defined as the proportion of subjects with response achieving CR or PR;

    Measured: 1 year

  4. Clinical Benefit Rate(CBR)

    According to RECIST V1.1 criteria,defined as the proportion of subjects with response achieving SD,PR or CR;

    Measured: 1 year

  5. Duration of Response (DoR)

    According to RECIST V1.1 criteria, defined as the time from the response to the confirmation of PD

    Measured: 1 year

  6. Ascites Remission Duration

    Defined as the time from the 1st as cites remission to as cites progression,according to the five-point method.

    Measured: 1 year

  7. 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.

    Measured: 1 year

  8. 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.

    Measured: 1 year

  9. The incidence of anti-drug antibodies(ADA) to catumaxomab in serum

    The incidence of anti-drug antibodies(ADA) to catumaxomab in serum

    Measured: 1 year

  10. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2020
  2. Study start6 Oct 2020
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion31 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
282 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04222114
Sponsor's protocol ID
LP0190415
Status last verified
Jan 2023
First submitted
5 Jan 2020
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Catumaxomab and The treatment of investigator choice in people with Stomach Neoplasms, run by LintonPharm Co.,Ltd. at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04222114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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