Study Of Activated Cytokine-induced Killer Armed With Bispecific Antibody For Advanced Pancreatic Cancer

Study Overview

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

This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 bispecific antibody for advanced pancreatic 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 pancreatic cancer.

Primary pancreatic carcinoma is one of the most common malignancies in China, 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 pancreatic cancer,and all patients are divided into three groups.one group will receive cryotherapy, one group will receive conventional 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.

Advanced Pancreatic Cancer

BIOLOGICAL: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Pancreatic Cancer
PROCEDURE: cryotherapy

CD3-MUC1 in pancreatic cancer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-04-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-10-13
First Submitted that Met QC Criteria 2018-04-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-10-19
First Posted (ACTUAL) 2018-04-26	Results First Posted N/A	Last Verified 2020-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cryotherapy the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.	BIOLOGICAL: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Pancreatic 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.
ACTIVE_COMPARATOR: Cryotherapy & Activated CIK and bispecific antibody 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 Pancreatic 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.
NO_INTERVENTION: Conventional therapy 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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Cryotherapy

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

BIOLOGICAL: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Pancreatic 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.

ACTIVE_COMPARATOR: Cryotherapy & Activated CIK and bispecific antibody

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 Pancreatic 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.

NO_INTERVENTION: Conventional therapy

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).

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate	ORR.The proportion of patients who had a best response rating of complete response and partial response.	1 year

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

18-75 years old
The patient is diagnosed as advanced pancreatic 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
The patient can't tolerate system(systemic chemotherapy/molecular targeted therapy) or local therapies
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
No serious disease are conflicts with the solution(such as autoimmune disease,immunodeficiency,organ transplantation)
Sign the informed consent

medium or above ascites
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

Investigators

STUDY_CHAIR: Jibing Chen, Doctor, Guangzhou Fuda Cancer Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record