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

N/ANot Yet RecruitingNCT07188857

Hubei Cancer Hospital100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Pain Management Immune Checkpoint Inhibitor Opioid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

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.

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

Data from ClinicalTrials.gov

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