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

Advanced Liver Cancer Clinical Trial

Official title:

Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Liver Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03484962
• Other study ID #: CIK and Bispecific Antibody
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 25, 2018
• Est. completion date: August 25, 2020

Study information

• Verified date: May 2020
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 25, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Liver Cancer
• Liver Neoplasms

Intervention

Biological:
• Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver 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.

Locations

Country	Name	City	State
China	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong
China	Institutional Review Board of Guangzhou Fuda Cancer Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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