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Esophageal Squamous Cell CarcinomaPhase 2NCT02490735

CIK in Treating Patients With Esophageal Cancer

A Phase 2 study testing Cytokine-induced Killer Cells in people with Esophageal Squamous Cell Carcinoma, run by The First People's Hospital of Changzhou.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Chemotherapy is the main treatment method for patients with Esophageal Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Cytokine-induced Killer Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
No sites listed yet
Study dates
Aug 2015to Aug 2042
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients histologically confirmed esophageal carcinoma;
  • Patients with staging I-III of esophageal carcinoma;
  • Patients who had completed chemotherapy;
  • Patients who have a life expectancy of at least 12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
  • The bone marrow functioned normally (WBC>4.0×10^9/L, Hb>120 g/L, Platelet(PLT)>100×10^9/L);
  • The ECG results were normal, and the liver and kidney were functional.

Who cannot join

  • Patients who had distant metastases by imaging studies;
  • Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
  • Patients who were lactating;
  • ECOG perform status ≥ 2;
  • Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
  • Patients who are pregnant or nursing;
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  • Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
  • Patients with disease that would preclude general anesthesia;
  • Patients with active intractable or uncontrollable infection.

About this study

Official title: A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Esophageal Carcinoma

Chemotherapy is the main treatment method for patients with Esophageal Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Esophageal Cancer.

Read the detailed description

About 2000 patients with staging I-III of Esophageal Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.

Being tested
Cytokine-induced Killer Cells
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Cytokine-induced Killer CellsBiological

    Also called CIK

    chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment

Study groups in NCT02490735
Study groupRoleWhat they receive
No-CIKNo interventionAfter accepting chemotherapy, patients will regularly follow up.
CIKExperimentalAfter accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year
Receives: Biological: Cytokine-induced Killer Cells

What is being measured

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

  1. progression-free survival(PFS)

    Measured: 1 month

Secondary outcomes (1)

  1. overall survival(OS)

    Measured: 1 month

Timeline

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

  1. First posted7 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionAug 2040 (estimated)
  4. Study completionAug 2042 (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
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02490735
Sponsor's protocol ID
ESCC-CZYY-01
Status last verified
Jul 2015
First submitted
2 Jul 2015
Last updated
7 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytokine-induced Killer Cells in people with Esophageal Squamous Cell Carcinoma, run by The First People's Hospital of Changzhou.

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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

progression-free survival(PFS) (time frame: 1 month). 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 NCT02490735.

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 7 Jul 2015.

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