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Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Gastric Cancer

Primary Purpose

Advanced Gastric Cancer

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Gastric cancer
Cryotherapy
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring PD-1 activated CIK, MUC1, bispecific antibody, gastric cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-75 years old
  • The patient is diagnosed as advanced gastric cancer,MUC1 is positive
  • There is at least one tumor should be measured,and length≥10mm of focus not at lymph node or length≥10mm of focus at lymph node
  • The patient can't tolerate system(systemic chemotherapy/molecular targeted therapy) or local therapies
  • If the patient received adjuvant chemotherapy after local treatment,the time should be more than 4 weeks after the end of chemotherapy, and disease progression or metastasis patients can also assigned into the group
  • The time of surgical treatment≥ 3 months ;At the end of the intervention,radiotherapy and the end of the ablation time is more than 4 weeks
  • The expected survival time ≥12 weeks
  • The patient did not took any antitumor drugs within 4 weeks(any antitumor drugs, Chinese patent medicine including Delisheng injection,Kanglaite injection, Aidi injection
  • No serious disease are conflicts with the solution(such as autoimmune disease,immunodeficiency,organ transplantation)
  • Sign the informed consent

Exclusion Criteria:

  • medium or above ascites
  • Patient of second primary tumor or multiple primary cancer
  • Patients of T cell lymphoma、myeloma,and patients are using immunosuppressant
  • Systemic autoimmune diseases, allergic constitution or immunocompromised patients
  • Patients of chronic diseases need immune stimulant or hormone therapy
  • Patients of active bleeding or coagulant function abnormality(PT>16s、APTT>43s、TT>21s、INR≥2),and patients of bleeding tendency or are receiving thrombolysis and anticoagulation and antiplatelet therapy
  • Women who is pregnant or during breast feeding or plan to pregnant in 2 years,and not willing to contraception during the test
  • Patients with brain、dura mater metastases or history of psychogenic
  • Gastrointestinal bleeding in the past six months or have clear gastrointestinal bleeding tendency,such as: patients of local active ulcerative lesions, defecate occult blood + + above shall not enter into group; defecate occult blood + depend on gastroscopy
  • Patients with severe stomach/esophageal varices and need for intervention treatment
  • Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within 4 weeks before the first treatment
  • Positive for HIV antibody
  • Patients who are allergic to computed tomography (CT) and magnetic resonance imaging (MRI) contrast agents at the same time, can't imaging assay
  • Patients accepted any experimental drugs or pilot medical apparatus and instruments in the past 4 weeks of first treatment
  • Other reasons the researchers think not suitable

Sites / Locations

  • Institutional Review Board of Guangzhou Fuda Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Cryotherapy

Cryotherapy & Activated CIK and bispecific antibody

Conventional therapy

Arm Description

the maximum tumor length≥2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.

the maximum tumor length≥2cm, use cryotherapy. the maximum tumor length<2 cm,Biological/Vaccine:Activated CIK and bispecific antibody CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1

In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Outcomes

Primary Outcome Measures

Objective response rate
ORR.The proportion of patients who had a best response rating of complete response and partial response.

Secondary Outcome Measures

Progression-free survival
PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause.
Time tumor progression
TTP.The time of patient from randomization to objective progress of the tumor.
Disease control rate
DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease.
Overall survival
OS.The time of patient from randomization to death caused by any cause
Symptom remission rate
SRR. The proportion of symptoms are alleviated in all evaluative cases.

Full Information

First Posted
May 31, 2018
Last Updated
October 13, 2020
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03554395
Brief Title
Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Gastric Cancer
Official Title
Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 bispecific antibody for advanced gastric cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1 bispecific antibody for gastric cancer.
Detailed Description
Primary gastric carcinoma is one of the most common malignancies in China, Immunetherapy is considered to be one of the most promising means of human against cancer. This is a phase II clinical trial of single- center, The investigators plan to recruit for 90 patients with advanced gastric cancer,and all patients are divided into three groups.one group will receive cryotherapy, one group will receive conventional therapy,and the rest one will receive mixed liquor of activated CIK and anti-CD3-MUC1 bispecific antibody together with cryotherapy. The result of this study was statistic and analysed with the record of Response Evaluation Criteria In Solid Tumors(RECIST1.1) evaluation standard.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
Keywords
PD-1 activated CIK, MUC1, bispecific antibody, gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a phase II clinical trial of single-center, and it will divide into three groups.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
With the method of minimum randomized dynamic random by the interactive network response system (IWRS),Participants were assigned to three groups,receive cryotherapy,conventional therapy, and activated CIK armed with anti-CD3-MUC1 bispecific antibody together with cryotherapy .every participant has a unique identification number and emergency letter which have the information of group.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
the maximum tumor length≥2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.
Arm Title
Cryotherapy & Activated CIK and bispecific antibody
Arm Type
Active Comparator
Arm Description
the maximum tumor length≥2cm, use cryotherapy. the maximum tumor length<2 cm,Biological/Vaccine:Activated CIK and bispecific antibody CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
Arm Title
Conventional therapy
Arm Type
No Intervention
Arm Description
In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Intervention Type
Biological
Intervention Name(s)
Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Gastric cancer
Intervention Description
CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy
Intervention Description
the maximum tumor length≥2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.
Primary Outcome Measure Information:
Title
Objective response rate
Description
ORR.The proportion of patients who had a best response rating of complete response and partial response.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause.
Time Frame
3 years
Title
Time tumor progression
Description
TTP.The time of patient from randomization to objective progress of the tumor.
Time Frame
1 year
Title
Disease control rate
Description
DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease.
Time Frame
1 year
Title
Overall survival
Description
OS.The time of patient from randomization to death caused by any cause
Time Frame
3 years
Title
Symptom remission rate
Description
SRR. The proportion of symptoms are alleviated in all evaluative cases.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 years old The patient is diagnosed as advanced gastric cancer,MUC1 is positive There is at least one tumor should be measured,and length≥10mm of focus not at lymph node or length≥10mm of focus at lymph node The patient can't tolerate system(systemic chemotherapy/molecular targeted therapy) or local therapies If the patient received adjuvant chemotherapy after local treatment,the time should be more than 4 weeks after the end of chemotherapy, and disease progression or metastasis patients can also assigned into the group The time of surgical treatment≥ 3 months ;At the end of the intervention,radiotherapy and the end of the ablation time is more than 4 weeks The expected survival time ≥12 weeks The patient did not took any antitumor drugs within 4 weeks(any antitumor drugs, Chinese patent medicine including Delisheng injection,Kanglaite injection, Aidi injection No serious disease are conflicts with the solution(such as autoimmune disease,immunodeficiency,organ transplantation) Sign the informed consent Exclusion Criteria: medium or above ascites Patient of second primary tumor or multiple primary cancer Patients of T cell lymphoma、myeloma,and patients are using immunosuppressant Systemic autoimmune diseases, allergic constitution or immunocompromised patients Patients of chronic diseases need immune stimulant or hormone therapy Patients of active bleeding or coagulant function abnormality(PT>16s、APTT>43s、TT>21s、INR≥2),and patients of bleeding tendency or are receiving thrombolysis and anticoagulation and antiplatelet therapy Women who is pregnant or during breast feeding or plan to pregnant in 2 years,and not willing to contraception during the test Patients with brain、dura mater metastases or history of psychogenic Gastrointestinal bleeding in the past six months or have clear gastrointestinal bleeding tendency,such as: patients of local active ulcerative lesions, defecate occult blood + + above shall not enter into group; defecate occult blood + depend on gastroscopy Patients with severe stomach/esophageal varices and need for intervention treatment Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within 4 weeks before the first treatment Positive for HIV antibody Patients who are allergic to computed tomography (CT) and magnetic resonance imaging (MRI) contrast agents at the same time, can't imaging assay Patients accepted any experimental drugs or pilot medical apparatus and instruments in the past 4 weeks of first treatment Other reasons the researchers think not suitable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jibing Chen, Doctor
Organizational Affiliation
Guangzhou Fuda Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Institutional Review Board of Guangzhou Fuda Cancer Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China

12. IPD Sharing Statement

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Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Gastric Cancer

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