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

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?

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Key information

Conditions

Pain Management Agnosia Immune Checkpoint Inhibitor Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hubei Cancer Hospital

Other

Collaborators

Cancer Hospital Chinese Academy of Medical Science

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 23, 2025
Registry last updated: Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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