AzTrials
AzTrials

Advanced Liver CancerPhase 2NCT03484962

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

A Phase 2 study testing Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver Cancer and cryotherapy in people with Advanced Liver Cancer, run by Fuda Cancer Hospital, Guangzhou at 2 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Liver Cancer
What is being tested?
Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver Cancer and cryotherapy
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesChina
Study dates
25 Mar 2018to 25 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Biological treatment center in Fuda cancer hospital

    Guangzhou, Guangdong, 510000

  • Institutional Review Board of Guangzhou Fuda Cancer Hospital

    Guangzhou, Guangdong, 510665

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver Cancer, cryotherapy
Keywords
activated CIK, MUC1, bispecific antibody, liver cancer
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver CancerBiological

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

  • cryotherapyProcedure or surgery

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

Study groups in NCT03484962
Study groupRoleWhat they receive
CryotherapyExperimentalthe maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
Receives: Procedure: cryotherapy
Cryotherapy & Activated CIK and bispecific antibodyActive comparatorthe 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
Receives: Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver Cancer; Procedure: cryotherapy
No interventionNo interventionIn 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

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

    Measured: 1 year

Secondary outcomes (5)

  1. Progression-free survival

    PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause.

    Measured: 3 years

  2. Time tumor progression

    TTP.The time of patient from randomization to objective progress of the tumor.

    Measured: 1 year

  3. Disease control rate

    DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease.

    Measured: 1 year

  4. Overall survival

    OS.The time of patient from randomization to death caused by any cause

    Measured: 3 years

  5. Symptom remission rate

    SRR. The proportion of symptoms are alleviated in all evaluative cases.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2018
  2. Study start25 Mar 2018
  3. Primary completion25 May 2020
  4. Study completion25 Aug 2020

Why it stopped: No participants enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a phase II clinical trial of single-center, and it will divide into three groups.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484962
Sponsor's protocol ID
CIK and Bispecific Antibody
Status last verified
May 2020
First submitted
26 Mar 2018
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver Cancer and cryotherapy in people with Advanced Liver Cancer, run by Fuda Cancer Hospital, Guangzhou at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03484962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in