Solid tumor
Conditions
Interventions
Observation group:None
Sponsors
Department of Oncology, First Affiliated Hospital of Fourth Military Medical University.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary enrollment with signed written informed consent; 2.Age >= 18 years; 3.Histologically or cytologically confirmed solid malignant tumors with documented metastasis to solid organs via imaging or pathology; 4.ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1; 5.No indications for local treatment (surgical resection, radiofrequency ablation, interventional therapy, etc.) at the time of enrollment; 6.At least one measurable lesion confirmed by imaging according to the RECIST 1.1 criteria; metastatic lesions at the site of previously treated local lesions may be considered measurable if progression is confirmed; 7.Eligible for treatment with immune checkpoint inhibitors based on guidelines, clinical studies, or investigator judgment, and consent to the treatment plan; 8.Expected survival of >= 6 months; 9.Adequate organ function, defined by the following criteria (without receiving any blood components or growth factors within 14 days prior to enrollment): (1). Neutrophils >= 2.0 × 10^9/L; (2). White blood cells >= 3.0 × 10^9/L; (3). Platelets >= 100 × 10^9/L; (4). Hemoglobin >= 90 g/L; (5). Total bilirubin = 50%. 10.Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrollment and agree to use appropriate contraception during the treatment period and for 6 months after treatment. Male participants must be surgically sterilized or agree to use appropriate contraception during the study and for 3 months after treatment; 11.Voluntary participation in this study with signed informed consent; 12.Good compliance and agreement to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Not confirmed as malignant tumors by histopathology or cytopathology, or absence of assessable lesions in solid organs confirmed by pathology or imaging; 2. Unable to adhere to the study protocol for treatment or follow-up; 3. Received any other clinical trial drug treatment within 4 weeks prior to enrollment, except for observational (non-interventional) clinical studies or interventional clinical studies for follow-up; 4. Severe gastrointestinal dysfunction (e.g., bleeding, obstruction; > grade 2 inflammation; > grade 1 diarrhea); 5. Known interstitial lung disease, except for interstitial changes shown only by imaging; 6. Known peripheral neuropathy (CTCAE >= grade 2); 7. Experienced a severe infection (CTCAE > grade 2) within 4 weeks prior to enrollment, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; symptoms and signs of infection requiring intravenous antibiotic treatment within 2 weeks prior to enrollment (excluding prophylactic antibiotic use); 8. Severe coagulation dysfunction, bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (<= 100 mg/day) and low molecular weight heparin (e.g., enoxaparin 40 mg/day and equivalent doses of other low molecular weight heparins) is permitted; 9. Uncontrolled cardiac clinical symptoms or diseases, including but not limited to: (1). NYHA class 3 or higher heart failure; (2).Unstable angina; (3) Myocardial infarction within the past 6 months; 10. Other conditions deemed unsuitable for immune checkpoint inhibitor therapy by the investigator; 11. History of other tumors within 5 years prior to enrollment, except for adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 12. Known acquired immunodeficiency syndrome (AIDS) or positive HIV test, or active syphilis infection; 13. History of significant neurological or psychiatric disorders, including epilepsy or dementia; 14. Individuals planning to become pregnant, pregnant women, or breastfeeding women; 15. At the investigator's discretion, the subject has other factors that may lead to premature termination of the study, such as non-compliance with the protocol, other serious illnesses requiring concurrent treatment, clinically significant laboratory values that are severely abnormal, or family or social factors that may affect the subject's safety or the collection of trial data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate; | — |
Countries
China
Contacts
Public ContactHongchen Ji
Department of Oncology, First Affiliated Hospital of Fourth Military Medical University.
Outcome results
None listed