ClinicalTrials.gg
Not yet recruitingNCT07188857Updated Sep 23, 2025

Study on the Relationship Between Opioid Drugs and the Therapeutic Efficacy of Immunotherapy

An observational study in Pain Management, Immune Checkpoint Inhibitor and Opioid, sponsored by Hubei Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Hubei Cancer Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Relationship between pain and the efficacy of immunotherapy: Does the degree of pain control affect the therapeutic efficacy of ICIs? Does the use of opioid drugs independently affect the efficacy of immunotherapy?

02

Conditions studied

  • Pain Management
  • Immune Checkpoint Inhibitor
  • Opioid

Keywords

  • pain management
  • opioids
  • immune checkpoint inhibitor
03

In context

Lead sponsor

Hubei Cancer Hospital is the lead sponsor of 25 studies on the registry; 17 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

hospital based study

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

  • Aged ≥ 18 years; confirmed advanced NSCLC (Stage IIIb-IV); Need to receive ICIs treatment; Accompanied by moderate or severe pain (NRS score ≥ 4); Need to use opioid drugs for pain management; Able to understand and sign the form.

Exclusion criteria

Exclusion Criteria:

  • Suffering from severe dysfunction of important organs such as heart, liver, and kidney; Suffering from mental illness or receiving treatment with psychotropic drugs; Pregnant or lactating women; Participating in other clinical trials; Allergic to opioid drugs.
Terms in these criteria, in plain language(2)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • immunotherapy group with opioids

    immunotherapy group with opioids

  • immunotherapy group without opioids

    immunotherapy group without opioids

06

What researchers measure

Primary outcomes

  1. The relationship between different degrees of pain control and the therapeutic efficacy of ICIs (immune checkpoint inhibitors) in patients with advanced cancer pain.

    The therapeutic efficacy includes progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). Additionally, analyze whether the use of opioid drugs independently affects the therapeutic efficacy.

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — all collected IPD

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 3 months and ending 3 years after the publication of results

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2025; primary completion for Oct 2027, 24 months later.

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

Registered
Sep 16, 2025
First posted
Sep 23, 2025
StartEst.
Sep 17, 2025
Primary completionEst.
Oct 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Sep 23, 2025
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 Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07188857
Lead sponsor
Hubei Cancer Hospital
Collaborators
Cancer Hospital Chinese Academy of Medical Science
Responsible party
Yu Qian (Doctor, Hubei Cancer Hospital) — Principal investigator
First posted
Sep 23, 2025
Start date
Sep 17, 2025 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Sep 23, 2025

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 not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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