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 CIKActivated CIK armed with bispecific antibody treatment group
CIKTraditional CIK treatment group

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 China, 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 80 cases patients with advanced liver cancer,
      the first 20 cases were directly received treatment of activated CIK, and the cases after the
      20th were randomly assigned to two group,one of the two group will receive treatment of
      traditional CIK, and the other receive activated CIK. 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 armed with bispecific antibody treatment groupExperimentalCIK cells were activated by bispecific antibody of anti-CD3-MUC1/CEA/EpCAM/GPC3
  • Activated CIK
Traditional CIK treatment groupActive ComparatorCIK cells were not activated
  • 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 ≥4 months;

         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≥50×10^9/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

February 1, 2021