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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Withdrawn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

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

NCT ID

NCT03554395

First Posted

May 31, 2018

Last Updated

October 13, 2020

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Arm Title

Conventional therapy

Arm Type

No Intervention

Arm Description

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

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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