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Status unknownNCT04268108Updated Jun 11, 2020

L-TIL in Patients With Malignancy Resistance to Anti-PD-1 Therapy

An observational study in Advanced Solid Tumor, sponsored by Henan Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Henan Cancer Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy

02

Conditions studied

  • Advanced Solid Tumor

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Keywords

  • liquid tumor-infiltrating lymphocytes
  • anti-PD-1
  • resistance
  • solid tumor
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 30 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Eligible patients in our hospital

Inclusion criteria

  • Expected lifespan is over 3 months
  • malignant tumors diagnosed by pathological examination
  • Imaging examination is at advanced stage with at least one measurable lesion
  • Ineffective or resistant to previous anti-PD-1 therapy
  • ECOG score 0-2
  • Adequate organ function
  • No other serious diseases that conflict with this protocol
  • Women of childbearing age must check for a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the test and within 3 months
  • witten informed consent from the patients

Exclusion criteria

Exclusion Criteria:

  • Severe infectious disease within 4 weeks before enrollment
  • Active hepatitis B or C virus or HIV infection
  • Severe autoimmune disease or immunodeficiency disease
  • Severe allergies
  • Severe mental disorder
  • Systematically used a large amount of glucocorticoids within 4 weeks before enrollment
  • With severe heart, liver, kidney insufficiency, diabetes and other diseases
  • Participation in other clinical studies in the past 3 months or having been treated with other gene products
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1

    arm 1: secondary resistance to anti-PD-1 therapy: this patients group received liquid tumor infiltrating lymphocytes combined anti-PD-1 therapy. arm 2: primary resistance to anti-PD-1 therapy: this patients group received FC preconditioning before received liquid tumor infiltrating lymphocytes

    Biological: liquid tumor infiltrating lymphocytes

Interventions

  • Biologicalliquid tumor infiltrating lymphocytes

    Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.

06

What researchers measure

Primary outcomes

  1. the rate of reverse events

    the rate of reverse events

    Time frame: three months

Secondary outcomes

  1. clinical benefit rate

    the proportion of patients benefit from liquid tumor infiltrating lymphocytes

    Time frame: three months

  2. time to progression

    from the date of therapy to the first date of determined progressive disease

    Time frame: six months

07

Study locations

1 of 1 sites recruiting
  • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
    Zhengzhou, Henan 450008, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Need to solicit patients' consent whether to agree to share their information during the enrollment process,

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 Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04268108
Lead sponsor
Henan Cancer Hospital
Responsible party
Sponsor
First posted
Feb 13, 2020
Start date
Apr 2, 2020
Primary completion
Feb 19, 2022 (estimated)
Completion
Jun 19, 2022 (estimated)
Last update
Jun 11, 2020

Study contacts

Quanli Gao, Dr.
Contact
gaoquanli2015@126.com
+86-371-65587795
Tiepeng Li, Dr.
Contact
claylee5405@163.com
+86-371-65587199

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 status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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