Cancer pain (caused by bone metastasis in the chest wall, sacrum, and ilium)
Conditions
Interventions
Trial Group:Cryoablation combined with Pucotenmab
Control Group:Radiotherapy combined with Pucotenmab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Age 18-75 years, both genders; 3. Histologically or cytologically confirmed malignant tumor with bone metastasis (chest wall, sacrum, ilium); 4. NRS score >3 or >3 breakthrough pain episodes per day despite standard analgesic therapy for >1 week; 5. At least one measurable lesion (RECIST 1.1); 6. Unsuitable or unwilling to undergo surgery; 7. ECOG PS 0-1; 8. Adequate organ function; 9. Negative pregnancy test for women of childbearing potential.
Exclusion criteria
Exclusion criteria: 1. Allergy to study drugs; 2. Active autoimmune disease; 3. Requiring systemic corticosteroids or immunosuppressive drugs; 4. Concurrent malignancies requiring treatment; 5. Poor compliance, severe concurrent diseases (e.g., uncontrolled hypertension), or deemed unsuitable by investigators; 6. HIV positive, pregnant/lactating, or organ transplant history; 7. Prior failure with cryoablation combined with PD-1 inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Improvement of physical symptoms and overall health assessed by ESAS; | — |
Countries
China
Contacts
Public ContactHuang Jinhua
Sun Yat-sen University Cancer Center
Outcome results
None listed