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Advanced Liver CancerPhase 2NCT03146637

Study of Activated CIK Armed With Bispecific Antibody for Advanced Liver Cancer

A Phase 2 study testing Activated CIK and CIK in people with Advanced Liver Cancer, run by Benhealth Biopharmaceutical (Shenzhen) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 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/CEA/EpCAM/GPC3 bispecific antibody for… 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 CIK
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 May 2017to 28 Jan 2021
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/CEA/EpCAM/GPC3 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;
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  • 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 ≥4 months；
  • The patient did not took any antitumor drugs within two weeks(any antitumor drugs, Chinese patent medicine including Delisheng injection, Kanglaite injection, Aidi injection, huaier granule and Ganfule Pian);
  • ECOG Score ≤1；
  • HBV DNA<10^4copies/ml（2000IU/ml);
  • Serum albumin≥28g/L,ALT and AST≤5.0×ULN,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≥50×10^9/L;
  • No serious disease are conflicts with the solution(such as autoimmune disease,immunodeficiency,orgen 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;;
  • 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;
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  • Women who is pregnant or during breast feeding or plan to pregnant in 2 years,and not willing to contraception during the test;
  • Any significant clinical and laboratory abnormalities, the researchers think that affect the safety, such as: incontrollable active infection (> NCI - CTC AE v4.0 standard level 2), uncontrolled diabetes (> level 2 of NCI - CTC AE v4.0 ), hypertension and can't be controlled by two or less hypotensor(systolic pressure < 140 mmHg, diastolic pressure < 90 mmHg), grade II or above peripheral neuropathy (NCI CTC AE v4.0), grade II or above congestive heart failure (NCI CTC AE v4.0), myocardial infarction in 6 month, thyroid dysfunction (> level 2 of NCI - CTC AE v4.0), etc;
  • Patients with brain、dura mater metastases or history of psychogeny;
  • 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 glomenrular 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

1 site in 1 country.

Jiamin Cheng, Doctor contact

+86-10-66933129 ext. 6030

chengjiamin300@163.com

China1 site, 1 recruiting

  • 302 Military Hospital of China

    Beijing, Beijing Municipality, 100039

    Jiamin Cheng, Doctor, +86-10-66933129 ext. 6030, chengjiamin300@163.com

    Yinying Lu

    Recruiting

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/CEA/EpCAM/GPC3 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/CEA/EpCAM/GPC3 bispecific antibody for liver cancer.

Read the detailed description

Liver cancer is one of the most common malignancies in China, ranking fourth in all malignant tumors and third in mortality. Immunetherapy is considered to be one of the most promising means of human against cancer. This is a phase II clinical trial of single-center, randomized (1:1of targeted activation CIK and traditional CIK therapy )comparison clinical trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for advanced liver cancer. The investigators plan to recruit for 80 cases patients with advanced liver cancer, the first 20 cases were directly received treatment of activated CIK, and the cases after the 20th were randomly assigned to two group，one of the two group will receive treatment of traditional CIK, and the other receive activated CIK. 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, CIK
Keywords
Activated CIK, MUC1/CEA/EpCAM/GPC3, Bispecfic 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 CIKBiological

    Activated CIK armed with bispecific antibody were infused for 3 days，after 2 days，bispecific antibody was infused separately for 3 days

  • CIKBiological

    Traditional CIK were infused for 3 days

Study groups in NCT03146637
Study groupRoleWhat they receive
Activated CIK armed with bispecific antibody treatment groupExperimentalCIK cells were activated by bispecific antibody of anti-CD3-MUC1/CEA/EpCAM/GPC3
Receives: Biological: Activated CIK
Traditional CIK treatment groupActive comparatorCIK cells were not activated
Receives: Biological: CIK

What is being measured

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

  1. OS

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

    Measured: 3 years

Secondary outcomes (5)

  1. PFS

    Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause.

    Measured: 3 years

  2. TTP

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

    Measured: 1 years

  3. DCR

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

    Measured: 1 years

  4. ORR

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

    Measured: 1 years

  5. SRR

    Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases.

    Measured: 1 years

Timeline

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

  1. First posted10 May 2017
  2. Study start1 May 2017
  3. Primary completion27 Jan 2021 (estimated)
  4. Study completion28 Jan 2021 (estimated)

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, randomized (1:1of targeted activation CIK and traditional CIK therapy ).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03146637
Sponsor's protocol ID
BK2016.01
Status last verified
Jan 2021
First submitted
2 May 2017
Last updated
1 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Activated CIK and CIK in people with Advanced Liver Cancer, run by Benhealth Biopharmaceutical (Shenzhen) Co., Ltd. at 1 site 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 16 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Jiamin Cheng, Doctor (+86-10-66933129 ext. 6030, chengjiamin300@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: 3 years). 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 NCT03146637.

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 1 Feb 2021.

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