The study is being conducted to evaluate the efficacy, and safety of SHR-2017 Injection in Patients with Bone Metastases from Solid Tumors. To explore the reasonable dosage of SHR-2017 Injection for Bone Metastases from Solid Tumors
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
SHR-2017; high dose ;Denosumab placebo
SHR-2017; low dose ;Denosumab placebo
Denosumab;SHR-2017 placebo
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGTime to pain relief
Analgesic evaluation using NRS scores
Time frame: randomization to 48 weeks after administration
percentage of change in the bone turnover marker urine N-telopeptide corrected for urine creatinine (uNTx/Cr) from baseline to study week 13
Time frame: randomization to 13 weeks after administration
Time to first on-study SRE (defined as pathologic fracture, radiation or surgery to bone, or spinalcord compression).
Time frame: randomization to 72 weeks after administration
Change from Baseline in the daily average pain intensity in the index bonemetastasis cancer pain site.
Time frame: randomization to 48 weeks after administration
Change from Baseline in the daily worst pain intensity in the index bonemetastasis cancer pain site.
Time frame: randomization to 48 weeks after administration
Response as defined by a ≥2 point reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site
Time frame: randomization to 48 weeks after administration
Average daily total opioid consumption (in mg of morphine equivalent doses)
Time frame: randomization to 48 weeks after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.