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

Hubei Cancer Hospital

Status: Not yet enrolling

Conditions: Immune Checkpoint Inhibitor; Pain Management; Opioid

Study type: Observational

Funder types: Other

Identifiers

NCT07188857

OPIOIDS

Details and patient eligibility

About

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?

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

immunotherapy group with opioids

Description:

immunotherapy group with opioids

immunotherapy group without opioids

Description:

immunotherapy group without opioids