NCT03524274

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2020

Completed
Last Updated

October 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2.1 years

First QC Date

May 2, 2018

Last Update Submit

October 13, 2020

Conditions

Advanced Colorectal Cancer

Keywords

PD-1 activated CIKMUC1bispecific antibodyColorectal 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 colorectal cancerProcedure: Cryotherapy

Conventional therapy

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 colorectal cancerBIOLOGICAL

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

Cryotherapy & Activated CIK and bispecific antibody
CryotherapyPROCEDURE

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

Cryotherapy & Activated CIK and bispecific antibodycryotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • The patient is diagnosed as advanced colorectal 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutional Review Board of Guangzhou Fuda Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jibing Chen, Doctor

    Guangzhou Fuda Cancer Hospital

    STUDY CHAIR
0

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,conventional 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
Model Details: This is a phase II clinical trial of single-center, and it will divide into three groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 14, 2018

Study Start

April 5, 2018

Primary Completion

May 20, 2020

Study Completion

August 5, 2020

Last Updated

October 19, 2020

Record last verified: 2020-05

Locations

CN(1)