Clinical trial NCT03484962: Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Liver Cancer
Official title: Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Liver Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Advanced Liver Cancer
Keywords: activated CIK
MUC1
bispecific antibody
liver cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
First posted: 2018-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase II clinical trial of single-center, and it will divide into three groups.
Primary purpose: TREATMENT

Brief summary: This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 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 bispecific antibody for liver cancer.

Detailed description: Primary hepatocellular carcinoma is one of the most common malignancies in China, ranking fourth in all malignant tumors and third in mortality.immunotherapy 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 liver cancer,and all patients are divided into three groups.one group will receive cryotherapy, one group will receive Non-intervention 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.

Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* The patient is diagnosed as advanced liver 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
* C interval of BCLC
* The patient can't tolerate system(systemic chemotherapy/molecular targeted therapy) or local therapies
* Child-Pugh Score ≤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
* 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
* Hepatitis B virus(HBV) DNA\<10\^4copies/ml（2000IU/ml)
* Serum albumin≥28g/L,TBIL≤1.5×ULN,electrolyte is normal, proteinuria = 0 \~ 1 +, serum creatinine≤1.5 x ULN
* 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
* No serious disease are conflicts with the solution(such as autoimmune disease,immunodeficiency,organ transplantation)
* Sign the informed consent

Exclusion Criteria:

* Severe cirrhosis, medium or above ascites
* Cancer embolus in the main portal vein and first branch, Hepatic duct and first branch, hepatic vein, inferior vena cava
* 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
* Patients with glomerular filtration rate abnormal obviously(The endogenous creatinine clearance \< 60 ml/min or serum creatinine \> 1.5 x ULN)
* 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

Primary outcomes:
measure: Objective response rate
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 years
measure: Time tumor progression
timeFrame: 1 year
measure: Disease control rate
timeFrame: 1 year
measure: Overall survival
timeFrame: 3 years
measure: Symptom remission rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
city: Guangzhou
country: China
facility: Institutional Review Board of Guangzhou Fuda Cancer Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou Fuda Cancer Hospital
name: Jibing Chen, Doctor
role: STUDY_CHAIR
References: