High-grade Osteosarcoma Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter，Phase III Clinical Study of Recombinant Anti-PD-L1 Monoclonal Antibody (ZKAB001) for Maintenance Therapy in Patients With High-grade Osteosarcoma After Adjuvant Chemotherapy
It is a randomized, double-blind, placebo-controlled, multicenter study with the sample size is 362. The patients with high-grade osteosarcoma who had previously received surgery and completed adjuvant chemotherapy will be randomly assigned to ZKAB001 group (trial group) or placebo group (control group) according to 1:1. The purpose is to evaluate the efficacy and safety of ZKAB001 in maintenance therapy after adjuvant chemotherapy in patients with high-grade osteosarcoma.
The patients will be given ZKAB001 injection in 10mg/kg or placebo once every 3 weeks for a
total of 16 cycles or 1 year. The end point is that the patient has been taking the drug for
16 cycles or 1 year, or the patient dies or develops intolerable toxicity or confirmed
disease recurrence or distant metastasis or withdrawal of informed consent, whichever comes
first.
In this study, after a screening period of no more than 28 days, qualified subjects will be
given ZKAB001 or placebo and test visits. Imaging examination will be performed every 12
weeks after the first dose until the local or distant recurrence of the disease, or the
initiation of other systematic anti-tumor therapy or death, whichever come first.
The survival follow-up period starts from the last treatment to a maximum of 4 years, or to
the death or loss of follow-up or withdrawal of informed consent or the sponsor terminates
the study every 3 months.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06068075 -
Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD
|
N/A |