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

NCT03484962 | Withdrawn Phase 2 DMC

• 1 other identifier: CIK and Bispecific Antibody
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Liver Cancer

Keywords

activated CIK; MUC1; bispecific antibody; liver cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  ORR.The proportion of patients who had a best response rating of complete response and partial response.

  1 year

Secondary Outcomes (5)

• Progression-free survival

  3 years

• Time tumor progression

  1 year

• Disease control rate

  1 year

• Overall survival

  3 years

• Symptom remission rate

  1 year

Study Arms (3)

Cryotherapy

EXPERIMENTAL

the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.

Procedure: cryotherapy

Cryotherapy & Activated CIK and bispecific antibody

ACTIVE COMPARATOR

the maximum tumor length≥2cm, use cryotherapy. the maximum tumor length\<2 cm,Biological/Vaccine:Activated CIK and bispecific antibody CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1

Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver Cancer; Procedure: cryotherapy

No intervention

NO INTERVENTION

In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Interventions

Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver Cancer BIOLOGICAL

CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1

Cryotherapy & Activated CIK and bispecific antibody

cryotherapy PROCEDURE

the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.

Cryotherapy; Cryotherapy & Activated CIK and bispecific antibody

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 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

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
• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.: collaborator

Study Sites (2)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

Institutional Review Board of Guangzhou Fuda Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jibing Chen, Doctor

  Guangzhou Fuda Cancer Hospital

  STUDY CHAIR

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 assigned to three groups,receive cryotherapy,non-intervention therapy, and activated CIK armed with anti-CD3-MUC1 bispecific antibody together with cryotherapy .every participant has a unique identification number and emergency letter which have the information of group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase II clinical trial of single-center, and it will divide into three groups.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: March 25, 2018
• Primary Completion: May 25, 2020
• Study Completion: August 25, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-05

Locations

CN (2)