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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04359550
Study type Interventional
Source Lee's Pharmaceutical Limited
Contact Yang Yao, Master
Phone 18930177737
Email yangyao_6@hotmail.com
Status Not yet recruiting
Phase Phase 3
Start date June 1, 2020
Completion date June 1, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06068075 - Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD N/A