Clinical Trials /

Study of Activated CIK Armed With Bispecific Antibody for Advanced Liver Cancer

NCT03146637

Description:

This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for advanced liver cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for liver cancer.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Activated CIK Armed With Bispecific Antibody for Advanced Liver Cancer
  • Official Title: Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Liver Cancer

Clinical Trial IDs

  • ORG STUDY ID: BK2016.01
  • NCT ID: NCT03146637

Conditions

  • Advanced Liver Cancer

Interventions

DrugSynonymsArms
Activated CIK and bispecific antibodyActivated CIK and bispecific antibody
Activated CIKActivated CIK

Purpose

This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for advanced liver cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for liver cancer.

Detailed Description

      Liver cancer is one of the most common malignancies in our country, ranking fourth in all
      malignant tumors and third in mortality. 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,
      randomized (1:1of targeted activation CIK and traditional CIK therapy )comparison clinical
      trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for
      advanced liver cancer. The investigators plan to recruit for 30 pairs of (60 cases) patients
      with advanced liver cancer, one of the two group will receive treatment of activated CIK, and
      the other receive mixed liquor of activated CIK and anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific
      antibody. The result of this study was statistic and analysed with the record of Response
      Evaluation Criteria In Solid Tumors(RECIST1.1) evaluation standard.
    

Trial Arms

NameTypeDescriptionInterventions
Activated CIK and bispecific antibodyExperimentalactivated CIK and Bispecific antibody of anti-CD3-MUC1/CEA/EpCAM/GPC3
    Activated CIKActive Comparatoractivated CIK

      Eligibility Criteria

              Inclusion Criteria:
      
                1. 18-75 years old;
      
                2. The patient is diagnosed as advanced liver cancer,MUC1/CEA/EpCAM/GPC3 is positive;
      
                3. 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;
      
                4. C interval of BCLC;
      
                5. The patient can't tolerate system(systemic chemotherapy/molecular targeted therapy) or
                   local therapies;
      
                6. Child-Pugh Score ≤7;
      
                7. 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;
      
                8. 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;
      
                9. The expected survival time ≥12 weeks;
      
               10. The patient did not took any antitumor drugs within two weeks(any antitumor drugs,
                   Chinese patent medicine including Delisheng injection, Kanglaite injection, Aidi
                   injection, huaier granule and Ganfule Pian);
      
               11. ECOG Score ≤1;
      
               12. HBV DNA<10^4copies/ml(2000IU/ml);
      
               13. Serum albumin≥28g/L,ALT and AST≤5.0×ULN,TBIL≤1.5×ULN, electrolyte is normal,
                   proteinuria = 0 ~ 1 +, serum creatinine≤1.5 x ULN;
      
               14. Tests of blood,liver and kidney should meet the following
                   criteria:WBC≥3×10^9/L,NEUT≥1×10^9/L,Hemoglobin ≥90 g/L,ANC≥1.5×109/L,PLT≥75×10^9/L;
      
               15. No serious disease are conflicts with the solution(such as autoimmune
                   disease,immunodeficiency,orgen transplantation);
      
               16. Sign the informed consent;
      
              Exclusion Criteria:
      
                1. Severe cirrhosis, medium or above ascites;
      
                2. Cancer embolus in the main portal vein and first branch, Hepatic duct and first
                   branch, hepatic vein, inferior vena cava;;
      
                3. Patients of T cell lymphomamyeloma,and patients are using immunosuppressant;
      
                4. Systemic autoimmune diseases, allergic constitution or immunocompromised patients.
      
                5. Patients of chronic diseases need immune stimulant or hormone therapy ;
      
                6. 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;
      
                7. Women who is pregnant or during breast feeding or plan to pregnant in 2 years,and not
                   willing to contraception during the test;
      
                8. Any significant clinical and laboratory abnormalities, the researchers think that
                   affect the safety, such as: incontrollable active infection (> NCI - CTC AE v4.0
                   standard level 2), uncontrolled diabetes (> level 2 of NCI - CTC AE v4.0 ),
                   hypertension and can't be controlled by two or less hypotensor(systolic pressure < 140
                   mmHg, diastolic pressure < 90 mmHg), grade II or above peripheral neuropathy (NCI CTC
                   AE v4.0), grade II or above congestive heart failure (NCI CTC AE v4.0), myocardial
                   infarction in 6 month, thyroid dysfunction (> level 2 of NCI - CTC AE v4.0), etc;
      
                9. Patients with brain、dura mater metastases or history of psychogeny;
      
               10. 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;
      
               11. Patients with severe stomach/esophageal varices and need for intervention treatment;
      
               12. Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess
                   within 4 weeks before the first treatment;
      
               13. Patients with glomenrular filtration rate abnormal obviously(The endogenous creatinine
                   clearance < 60 ml/min or serum creatinine > 1.5 x ULN);
      
               14. Positive for HIV antibody;
      
               15. Patients who are allergic to computed tomography (CT) and magnetic resonance imaging
                   (MRI) contrast agents at the same time, can't imaging assay;
      
               16. Patients accepted any experimental drugs or pilot medical apparatus and instruments in
                   the past 4 weeks of first treatment;
      
               17. Other reasons the researchers think not suitable.
            
      Maximum Eligible Age:75 Years
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:OS
      Time Frame:3 years
      Safety Issue:
      Description:Overrall survival.The time of patient from randomization to death caused by any cause.

      Secondary Outcome Measures

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

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

      Trial Keywords

      • Activated CIK
      • MUC1/CEA/EpCAM/GPC3
      • Bispecfic antibody
      • liver cancer

      Last Updated

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