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

Phase 2

Withdrawn

Conditions: Advanced Pancreatic Cancer

Interventions: Procedure: cryotherapy
Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Pancreatic Cancer

Registration Number: NCT03509298

Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: WITHDRAWN

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	cryotherapy	the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
Cryotherapy & Activated CIK and bispecific antibody	Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Pancreatic Cancer	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
Cryotherapy & Activated CIK and bispecific antibody	cryotherapy	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

Primary Outcome Measures

Name	Time	Method
Objective response rate	1 year	ORR.The proportion of patients who had a best response rating of complete response and partial response.

Secondary Outcome Measures

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

Trial Locations

Locations (1): Institutional Review Board of Guangzhou Fuda Cancer Hospital
🇨🇳
Guangzhou, Guangdong, China