solid tumor
Conditions
Interventions
Denosumab treatment group:Denosumab: Administered subcutaneously at a fixed dose of 120 mg every 28 days as a cycle until intolerable adverse reactions occur or the investigator deems that the patien
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria before being enrolled in this trial: 1.Be aged 18 years or older, regardless of gender. 2.Have a histologically or cytologically confirmed malignant solid tumor (excluding hematological malignancies). 3.Have at least one bone metastasis throughout the body diagnosed by imaging (bone X-ray, CT scan or magnetic resonance imaging) or pathological diagnosis (bone biopsy) according to the "Expert Consensus on Clinical Diagnosis and Treatment of Bone Metastases and Bone-Related Diseases in Malignant Tumors (2014)", and have experienced the first bone-related event within 2 months prior to enrollment. 4.Be expected to have a survival period of = 6 months as judged by the investigator. 5.Have an ECOG performance status score of 0, 1, or 2 at the time of enrollment. 6.Voluntarily participate in this clinical study and sign the informed consent form, and be willing to complete the trial in accordance with the provisions of the trial protocol. 7.Male and female patients with reproductive potential must agree to use adequate contraceptive measures from the date of signing the informed consent form until 5 months after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions cannot be enrolled in this study: 1.Women who are pregnant or breastfeeding. 2.Patients known to be allergic to the active ingredients of the study drug or its excipients. 3.Patients with hypocalcemia, that is, serum calcium (albumin-corrected) < 8.0 mg/dL or < 2.0 mmol/L, and without effective intervention. 4.Patients with acute dental or mandibular diseases requiring oral surgery; those planning to undergo invasive dental surgery; those with unhealed dental or oral surgeries. 5.Patients with major diseases such as severe cardiovascular and cerebrovascular diseases (including but not limited to myocardial infarction, heart failure, unstable angina pectoris, stroke), severe infections, and severe liver and kidney insufficiency. 6.Patients who are currently receiving other treatments that may affect the efficacy or safety of the study drug (such as other bone protective agents). 7.Situations judged by the investigator as not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time to recurrence of skeletal-related events(SRE2); | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with a recurrence of Skeletal - Related Events (SRE) within the third, sixth, and twelfth months.;The percentage change in lumbar spine bone mineral density compared to the baseline at the 6th and 12th months.;Overall survival;Pain status;Safety; | — |
Countries
China
Contacts
Public ContactRunmei Li, Dong Wang
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed