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

NCT03146637 | Unknown Phase 2 DMC

• 1 other identifier: BK2016.01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Liver Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• OS

  Overrall survival.The time of patient from randomization to death caused by any cause.

  3 years

Secondary Outcomes (5)

• PFS

  3 years

• TTP

  1 years

• DCR

  1 years

• ORR

  1 years

• SRR

  1 years

Study Arms (2)

Activated CIK armed with bispecific antibody treatment group

EXPERIMENTAL

CIK cells were activated by bispecific antibody of anti-CD3-MUC1/CEA/EpCAM/GPC3

Biological: Activated CIK

Traditional CIK treatment group

ACTIVE COMPARATOR

CIK cells were not activated

Biological: CIK

Interventions

Activated CIK BIOLOGICAL

Activated CIK armed with bispecific antibody were infused for 3 days，after 2 days，bispecific antibody was infused separately for 3 days

Activated CIK armed with bispecific antibody treatment group

CIK BIOLOGICAL

Traditional CIK were infused for 3 days

Traditional CIK treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• The patient is diagnosed as advanced liver cancer,MUC1/CEA/EpCAM/GPC3 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 ≥4 months；
• 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);
• ECOG Score ≤1；
• HBV DNA\<10\^4copies/ml（2000IU/ml);
• 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;
• 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;
• No serious disease are conflicts with the solution(such as autoimmune disease,immunodeficiency,orgen transplantation);

You may not qualify if:

• 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;;
• 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;
• 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;
• Patients with brain、dura mater metastases or history of psychogeny;
• 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 glomenrular 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;

Sponsors & Collaborators

• Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.: lead
• Beijing 302 Hospital: collaborator

Study Sites (1)

302 Military Hospital of China

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Yinying Lu, Doctor

  Liver Cancer Diagnosis & Treatment and Research Center of 302 Military Hospital of China

  STUDY DIRECTOR

Central Study Contacts

Jiamin Cheng, Doctor

CONTACT

+86-10-66933129; chengjiamin300@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: With the method of minimum randomized dynamic random by the interactive network response system (IWRS),Participants were randomly assigned to two groups,receive activated CIK or activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody,every participant has a unique identification number and emergency letter which have the information of group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a phase II clinical trial of single-center, randomized (1:1of targeted activation CIK and traditional CIK therapy ).

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 10, 2017
• Study Start: May 1, 2017
• Primary Completion: January 27, 2021
• Study Completion: January 28, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: When the study is finished

Locations

CN (1)