CClinicalTrials.gg
Status unknownNCT02862587Updated Sep 2, 2016

Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

A Phase 1/2 interventional study of Chemotherapy and precision cells in Precision Cells, Chemotherapy and Advanced Lung Cancer, sponsored by Shanghai International Medical Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2016-09-02.

Sponsored by Shanghai International Medical Center · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study summary

Objectives:

To evaluate the safety and effectiveness of cell therapy using precision cells to treat Advanced Lung Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.

Read the detailed description

A total of 40 patients may be enrolled over a period of 1-2 years.

02

Conditions studied

  • Precision Cells
  • Chemotherapy
  • Advanced Lung Cancer

Browse trials for

Keywords

  • Precision Cells
  • Chemotherapy
  • Advanced Lung Cancer
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 40 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Shanghai International Medical Center is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18\~65 years old, male or female;
  • Life expectancy≥6 months;
  • ECOG score: 0-3;
  • Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
  • Enough venous channel, no other contraindications to the separation and collection of white blood cells;
  • Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
  • Signed informed consent;
  • Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion criteria

Exclusion Criteria:

  • Expected Overall survival \< 6 months;
  • Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months;
  • Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
  • Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month;
  • Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Precision Cells

    precision cells combined with Chemotherapy treatment: Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. precision cells:once per 3 weeks with a total of three periods.

    Drug: Chemotherapy · Biological: precision cells

  • Active comparator
    Chemotherapy

    Once a week with a total of six times before 60 days prior to the start of drawing blood.

    Drug: Chemotherapy

Interventions

  • DrugChemotherapy

    Cisplatin:60mg/m2,Gemcitabine:1g/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.

  • Biologicalprecision cells

    precision cells DC cell suspension (1×10\*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PNAT/PMAT cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 2 years

  2. Progress-free survival

    Time frame: 2 years

Secondary outcomes

  1. Quality of life

    Questionnaire will be used.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Shanghai International Medical Center
    Shanghai, Shanghai 201318, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02862587
Lead sponsor
Shanghai International Medical Center
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
Aug 2016
Primary completion
Mar 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Sep 2, 2016

Study contacts

Naiyan Han
Contact
naiyan.han@simcgroup.com
+86 21 6023 6666

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion