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

Overview

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.

Full Title of Study: “Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Gastric Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 5, 2020

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.

Interventions

  • Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Gastric cancer
    • CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
  • Procedure: Cryotherapy
    • the maximum tumor length≥2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.

Arms, Groups and Cohorts

  • Experimental: Cryotherapy
    • the maximum tumor length≥2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.
  • Active Comparator: Cryotherapy & Activated CIK and bispecific antibody
    • 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
  • No Intervention: Conventional therapy
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Objective response rate
    • Time Frame: 1 year
    • ORR.The proportion of patients who had a best response rating of complete response and partial response.

Secondary Measures

  • Progression-free survival
    • Time Frame: 3 years
    • PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause.
  • Time tumor progression
    • Time Frame: 1 year
    • TTP.The time of patient from randomization to objective progress of the tumor.
  • Disease control rate
    • Time Frame: 1 year
    • DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease.
  • Overall survival
    • Time Frame: 3 years
    • OS.The time of patient from randomization to death caused by any cause
  • Symptom remission rate
    • Time Frame: 1 year
    • SRR. The proportion of symptoms are alleviated in all evaluative cases.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fuda Cancer Hospital, Guangzhou
  • Collaborator
    • Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jibing Chen, Doctor, Study Chair, Guangzhou Fuda Cancer Hospital
  • Overall Contact(s)
    • Jibing Chen, Doctor, +86-20-38993922, jibingchen398@163.com

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