Study on the Relationship Between Opioid Drugs and the Therapeutic Efficacy of Immunotherapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHubei Cancer Hospital
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
hospital based study
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: immunotherapy group with opioids
Group B: immunotherapy group without opioids
Trial outcomes
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 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hubei Cancer Hospital
Lead sponsor
Cancer Hospital Chinese Academy of Medical Science
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: