HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies

• Age ≥ 18 years old, weight ≥ 40 kg, gender not limited;
• Diagnosed as non myeloid malignant tumor through histology or cytology;
• Bone marrow suppression chemotherapy related anemia, defined as Hb ≤ 100 g/L during the screening period, and according to the researcher's judgment, there are records showing that the Hb level of the trial participants has decreased by ≥ 10 g/L after the start of previous chemotherapy;
• Plan to receive at least 6 weeks of tumor treatment simultaneously ;
• Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points;
• Expected survival time ≥ 6 months;
• ferritin ≥ 50 ng/mL and transferrin saturation (TSAT) ≥ 10%;

• Participants in the experiment must have appropriate organ function and meet all of the following laboratory test results before enrollment:

  1. Liver function: ALT and AST ≤ 3 × ULN; Serum bilirubin ≤ 1.5 × ULN;
  2. Renal function: According to the 4-variable MDRD equation, the estimated glomerular filtration rate (eGFR) is ≥ 50 mL/min/1.73 m2.
• Non lactating female trial participants; For female trial participants with fertility: During the screening period, the blood pregnancy test must benegative, and from informed consent signature through 3 months following the last study treatment dose have no plan for oocyte retrieval for in-vitro fertilization (IVF) and must agree to take effective contraceptive measures.

For male trial participants who have not been sterilized: from informed consent signature through 3 months following the last study treatment dose,have no plan to donate sperm and must agree to take effective contraceptive measures.

The definition and contraception guidelines for "women with fertility" can be found in section 15.3.

• Voluntarily participate in this study and sign a written informed consent form.

Exclusion Criteria:

• Participants receiving bone marrow suppressive chemotherapy with an expected outcome of cure;
• Uncontrolled central nervous system metastasis; Or confirm central nervous system metastasis, but have not been stabilized for more than 4 weeks after anti-tumor treatment (definition of stable central nervous system metastasis: no new neurological deficits caused by central nervous system metastasis have been found, no new lesions have been detected by central nervous system imaging examination, and no corticosteroid/steroid treatment is needed); Or malignant neoplasms with primary central nervous system origin or bone-marrow involvement, or malignant tumors of the myeloid system (such as chronic myeloid leukemia, etc.);
• Hematocrit (HCT) ≥ 36%;
• Plan to undergo major surgery during the treatment period;
• traditional Chinese patent medicines and simple preparations that has received anemia treatment within 2 weeks before randomization or RBC infusion or anemia treatment drugs within 4 weeks before randomization, including but not limited to erythropoiesis stimulators (ESAs) and their derivatives, hypoxia inducible factor proline hydroxylase (HIF-PHD) inhibitor, androgen and anabolic hormone drugs;
• Receive live vaccines (including attenuated live vaccines) within the first 4 weeks of randomization;
• Participants who have participated in any interventional clinical trials and received investigational drugs or medical device interventions within the first 4 weeks of randomization (excluding participants in overall survival follow-up trials who only participated in one study), or plan to use these drugs during their participation in this clinical trial;
• Only accept hormone preparations, biologics, novel immunosuppressive agents (such as PD-1 and PD-L1 immune checkpoint inhibitors), targeted biotherapy, or radiation therapy to treat/control their tumors. Note: If chemotherapy is combined with these drugs or if the treatment received contains antibody conjugated drugs (ADCs), it can be included in the study;
• Currently using or expected to use dapsone during the study treatment period;
• There is known, active, or chronic bleeding present;
• Anemia of clinical significance caused by other etiologies, such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, sickle cell anemia or thalassemia, etc;
• Persistent inflammation/autoimmune diseases that are clinically significant or uncontrolled (such as rheumatoid arthritis, Crohn's disease, celiac disease, etc.);

• Any of the following cardiovascular risk factors:

  1. Any history of significant clinical arrhythmia (such as rapid atrial fibrillation, high-grade atrioventricular block, ventricular tachycardia, ventricular fibrillation, or apical torsion ventricular tachycardia);
  2. Left ventricular ejection fraction (LVEF) is less than 50% during the screening period;
  3. Individuals who have had any of the following diseases within the first 12 months of randomization: myocardial infarction, coronary artery bypass grafting or peripheral artery bypass grafting surgery, heart failure (New York Heart Association functional class III-IV), etc; Or have unstable angina pectoris within the first 6 months of randomization; Or a history of severe valvular or endocardial disease that may put trial participants at risk of thromboembolism;
  4. Uncontrollable hypertension (despite receiving antihypertensive medication, systolic blood pressure>160 mmHg, or diastolic blood pressure>100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;
• Within the first 6 months of randomization, there has been a history of thrombosis or embolism events, such as cerebrovascular accidents (including transient ischemic attacks, excluding lacunar cerebral infarction), deep vein thrombosis, pulmonary embolism, etc., or receiving therapeutic doses of anticoagulant drugs within 2 weeks before the first medication;
• Prior to randomization, the investigater determined the presence of uncontrollable active systemic infections;
• Suffering from congenital or acquired immune dysfunction (such as HIV infected individuals); Or partcipants with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: who are HBsAg positive or HBcAb positive during the screening period need to be tested for HBV DNA, and HBV DNA quantification ≥ 104 cps/mL or ≥ 2000 IU/mL; Participants with positive HCV antibody test results require further HCV RNA testing, and have positive quantitative HCV RNA;
• History of severe liver disease or active liver disease;
• Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy;
• Individuals with a history of severe allergic diseases or drug allergies, or known allergies to rHuEPO injection or HEC53856 tablets;
• Individuals with a history of abuse of psychotropic drugs and unable to quit, or those with mental disorders;
• Researchers believe that patients with other serious acute or chronic diseases are not suitable to participate in clinical trials.