A Multicenter Randomized Controlled Study to Assess the Efficacy and Safety of rhTPO's Prophylactic Treatment of Cancer Treatment-induced Thrombocytopenia in Patients With High Risk of Treatment-induced Cardiac Injury
To assess the efficacy and safety of an optimised dosing regimen of rhTPO's prophylactic treatment of cancer treatment-induced thrombocytopenia(CTIT) and to explore the cardioprotective effect of rhTPO in cancer patients with high risk of treatment-induced cardiac injury.
• Males or females greater than or equal to 18 years of age at signing of the informed consent.
• Patients clinically judged to be at high risk of CTIT: Patients who had a platelet count below 50×10\^9/L in the past 3 months; or patients who meet the criteria for prophylactic treatment in the Chinese Expert Consensus on the Management of Thrombocytopenia due to Oncology Chemotherapy (2018 Edition).The criteria for prophylactic treatment include: 1) The nadir platelet value in the last chemotherapy cycle was \<50×10\^9/L;Or 2)The patients with nadir platelet value ≥50×10\^9/L and \<75×10\^9/L in the previous chemotherapy cycle also met at least one of the following risk factors for bleeding:
‣ With a previous history of bleeding.
⁃ Chemotherapy regimens containing platinum, gemcitabine, cytarabine, anthracycline, etc.
⁃ Combination regimens containing targeted or chemotherapy drugs which regularly result in thrombocytopenia.
⁃ Thrombocytopenia caused by bone marrow infiltration of tumor cells.
⁃ Eastern Cooperative Oncology Group (ECOG) score ≥2.
⁃ Previous radiotherapy or ongoing radiotherapy, especially for long and flat bones (e.g. pelvis, sternum, etc.).
• Platelet count ≥75×10\^9/L and \<150×10\^9/L, Hemoglobin ≥9.0 g/dL and absolute neutrophils ≥1.5×10\^9 /L during screening.
• Patients with medium and high-risk with cardiotoxicity risk score (CRS) ≥3 and ECOG score of 0, 1, or 2 during screening.
• The current tumor treatment belongs to the scope of neoadjuvant, adjuvant, relapsed metastatic/advanced first-line and second-line therapies, anticipated to receive at least 2 cycles of current regimen with survival ≥ 6 months. The regimens may be 14-day, 21-day or 28-day cycles combined with targeted, immunotherapy, etc.
• Inclusion of organ tumours and lymphomas, with no restriction on the type and stage of organ tumours, etc.
• Patient provided signed informed consent