pan-cancer
Conditions
Interventions
Patients who experience adverse reactions to immunotherapy:None
Patients who did not experience adverse reactions to immunotherapy:None
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed malignant tumors scheduled to receive PD-1 or PD-L1 inhibitor monotherapy or combination therapy; 2. No prior exposure to any immune checkpoint inhibitor therapy; 3. Age >= 18 years; 4. Must have the ability to understand and voluntarily provide written informed consent before the initiation of any trial-related procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with non-solid tumors; 2. Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, and hepatic, renal, or metabolic disease); 3. History of another malignancy within 5 years (except for completely cured carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer); 4. Presence of a primary immunodeficiency disease or relevant history; 5. Presence of an active autoimmune disease, or a history of autoimmune disease within 2 years prior to the first dose requiring systemic therapy. However, patients with the following conditions may be further eligible for screening: well-controlled type I diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia), or diseases not expected to recur in the absence of external triggers; 6. History of interstitial lung disease, or non-infectious pneumonitis requiring glucocorticoid therapy; 7. Any disease requiring systemic therapy with corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to the first dose of Immune Checkpoint Inhibitors (ICIs); 8. Any condition that may compromise patient safety or adherence to the study; 9. Considered by the investigator as unsuitable for participation in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune-related adverse events (irAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment efficacy; | — |
Countries
China
Contacts
Public ContactShuqing Wei
Shanxi Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University
Outcome results
None listed