QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.

To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.

Inclusion Criteria:

• Men and women, 18-75 years of age;
• Histopathological or cytological examination confirmed cancer , chemotherapy cycle of 21 days;
• Participant experienced thrombocytopenia and chemotherapy delay;
• ECOG performance status 0-1;
• The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles.

Exclusion Criteria:

• Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
• Participant has serious bleeding symptoms;
• History of allergy to the study drug;
• Patients with hepatitis C antibody positive and detection of HCV-RNA exceeding the upper limit, patients with hepatitis B surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, HIV antibody positive and syphilis antibody positive;
• Pregnant or lactating women;
• Participant has received any experimental therapy within 28 days prior to screening
• Other conditions that may affect participant's safety or trial evaluations per investigator's discretion