Pain ManagementNCT07188857
Study on the Relationship Between Opioid Drugs and the Therapeutic Efficacy of Immunotherapy
An observational study of Pain Management and Immune Checkpoint Inhibitor, run by Hubei Cancer Hospital.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Management, Immune Checkpoint Inhibitor, Opioid
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2025to 1 Oct 2027
- Phase
- Observational
- 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
Study population: hospital based study
Who may be able to join
- Aged ≥ 18 years; Histologically 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 informed consent form.
Who cannot join
- 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.
About this study
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?
- Conditions
- Pain Management, Immune Checkpoint Inhibitor, Opioid
- Keywords
- pain management, opioids, immune checkpoint inhibitor
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| immunotherapy group with opioids | immunotherapy group with opioids | |
| immunotherapy group without opioids | immunotherapy group without opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start17 Sep 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Hospital Chinese Academy of Medical Science
- Responsible party
- Principal investigator, Yu Qian, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188857
- Sponsor's protocol ID
- OPIOIDS
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Opioid Drugs and the Therapeutic Efficacy of Immunotherapy
- ClinicalTrials.gov ID
- NCT07188857
- Acronym / sponsor ID
- OPIOIDS
- Conditions
- Pain Management, Immune Checkpoint Inhibitor, Opioid
- Keywords
- pain management, opioids, immune checkpoint inhibitor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Collaborators
- Cancer Hospital Chinese Academy of Medical Science
- Study start
- 17 Sep 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunotherapy group with opioids | – | –immunotherapy group with opioids |
| immunotherapy group without opioids | – | –immunotherapy group without opioids |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital based study
Key inclusion criteria (1 listed)
- Aged ≥ 18 years; Histologically 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 informed consent form.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between different degrees of pain control and the therapeutic efficacy of ICIs (immune checkpoint inhibitors) in patients with advanced cancer pain.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management and Immune Checkpoint Inhibitor, run by Hubei Cancer Hospital.
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 1 inclusion and 1 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 23 Sep 2025. 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.
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?
The relationship between different degrees of pain control and the therapeutic efficacy of ICIs (immune checkpoint inhibitors) in patients with advanced cancer pain. (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.