ClinicalTrials.gg
CompletedNCT03360630Updated Feb 7, 2024

Anti-PD-1 Alone or Combined With Autologous Cell Therapy in Advanced NSCLC

A Phase 1/2 interventional study of Anti-PD-1 plus DC-CIK and Anti-PD-1 alone in Lung Cancer and Neoplasms, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Capital Medical University · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Nov 2016, registered Nov 2017).

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 844 studies in Lung Neoplasms with a site in China — 371 open to participants now, 418 under way, 34 of them phase 3. Lung Neoplasms · China.

Enrollment
346th of 585
60 · median 90
Started
2016
with 36 others
Phase 1/2
63 of 844
23 open now
Registered
195th of 844
by date

Among the 844 studies in Lung Neoplasms with a site in China, this one is the 346th largest by enrollment of the 585 interventional ones that give a count, is one of 37 that started in 2016, is one of 63 in phase 1/2, and was the 195th registered.

Lung Neoplasms

5,423 studies on the registry are indexed under Lung Neoplasms; 1,345 are open to participants now.

Browse Lung Neoplasms studies →

Open to participants now

371 of the 844 studies in Lung Neoplasms with a site in China are open now. Recruiting first, the newest first:

366 more — sign in →

All 371 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 995 Lung Neoplasms studies recruiting now, 682 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 844 studies in Lung Neoplasms with a site in China, or all of them as a file.
02

Study summary

A randomized controlled study to compared the clinical effects and safety of immunotherapy with dendritic cells and cytokine-induced killer cells administered with anti-PD-1 antibody in advanced NSCLC.

03

Conditions studied

  • Lung Cancer
  • Neoplasms
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • or cytologically confirmed advanced or NSCLC.
  • Patients must have received previously standard therapy for that or declined to chemotherapy/radiotherapy.
  • Estimated > 3 months.
  • (ECOG) performance status of 0,1 or 2.
  • Age 18 to 80.
  • Adequate hematologic function, with WBC ≥ 3000/microliter, ≥ 9 g/dL (it is acceptable to have had prior transfusion), ≥ 75,000/microliter; PT- \<1.5 (unless patient is receiving warfarin in which case PT-INR must be \<3), PTT \<1.5X
  • Adequate renal and hepatic function, with serum creatinine \< 1.5 mg/ dL, \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), and AST ≤ 2.5 x upper limit of normal.

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
  • Patients with serious intercurrent chronic or acute illness, such as cardiac disease ( class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for drug treatment.
  • Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
  • Concurrent (or within the last 5 years) second other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
  • Presence of an active acute or chronic infection including: a urinary tract infection, (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
  • Patients on chronic therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies or for acute treatment (\<5 days) of intercurrent medical condition such as a gout flare) prior to enrollment.
  • Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
  • Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

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

Study arms

  • Experimental
    Anti-PD-1 plus DC-CIK

    Biological: Anti-PD-1 plus DC-CIK

  • Active comparator
    Anti-PD-1 alone

    Biological: Anti-PD-1 alone

Interventions

  • BiologicalAnti-PD-1 plus DC-CIK

    Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal. DC-CIK Immunotherapy: Mononuclear cells were collected aseptically with blood cell separator composition apheresis, and cultured DC-CIK cells for 10-14 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.

  • BiologicalAnti-PD-1 alone

    Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.

This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Progression-free survival of the participants

    From starting date of anti-PD-1 antibody treatment until date of until the date of first documented disease progression or date of death from any cause, whichever comes first.

    Time frame: 12 months

Secondary outcomes

  1. Overall survival of the participants(OS)

    From starting date of anti-PD-1 antibody treatment until date of death from any cause

    Time frame: 24 months

  2. Assessment of Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PROCTCAE)

    To assess and compare the PRO-CTCAE by patients receiving immunotherapy

    Time frame: 24 months

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 24 months

  4. Molecular Tumor Burden Index

    Using mutation detection in ctDNA by liquid biopsy to assess tumor dynamics

    Time frame: 24 months

Other outcomes

  1. Cell-free tumor DNA

    To investigate the relationship of ctDNA with clincial outcomes

    Time frame: 24 months

  2. Tumor related antigen peptides

    To investigate the relationship of tumor related antigen peptides with clincial outcomes

    Time frame: 24 months

  3. T cell metaboic activity

    To investigate the relationship of T cell metaboic activity with clincial outcomes

    Time frame: 24 months

  4. Microbial bacteria

    To investigate the relationship of microbial bacteria with clincial outcomes

    Time frame: 24 months

07

Study locations

1 site
  • Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
    Beijing, 100038, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2016 to primary completion in Dec 2022, 73 months.

Of 78 non-industry phase 1/2 interventional studies under Lung Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 159. This study's 73 months is above that.

Counting every sponsor, half of 157 studies reached it within 54 months; a quarter within 40 and three quarters within 93.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2017
First posted
Dec 4, 2017
StartActual
Nov 1, 2016
Primary completionActual
Dec 31, 2022
CompletionActual
Jun 1, 2023
Last update
Feb 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03360630
Collaborators
Duke University, Geneplus-Beijing Co. Ltd.
Responsible party
Jun Ren MD, PhD (Director, Comprehensive Cancer Center, Capital Medical University) — Principal investigator
First posted
Dec 4, 2017
Start date
Nov 1, 2016
Primary completion
Dec 31, 2022
Completion
Jun 1, 2023
Last update
Feb 7, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. 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