A Study of Mitoxantrone Hydrochloride Liposome Injection Combination Therapy in Chinese Patients With Advanced Solid Tumors

Inclusion Criteria:

* Patients fully understand and voluntarily participate in this study and sign informed consent;
* Aged 18-65 years, male or female;
* Patients with advanced solid tumors confirmed by histopathology or cytologically and who have failed standard therapy;
* At least one measurable lesion according to RECIST v1.1 at baseline;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
* Adverse events（AEs） from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for alopecia, hyperpigmentation and the toxicity without safety risk judged by the investigator);
* Adequate organ function defined as:

  * Absolute neutrophil count (ANC) ≥1.5\*10\^9/L (No Granulocyte Colony Stimulating Factor treatment within 2 weeks prior to the laboratory test);
  * Hemoglobin ≥ 90 g/L (No red blood cell transfusion within 2 weeks prior to the laboratory test);
  * Platelet count ≥ 100\*10\^9/L (No platelet transfusion within 2 weeks prior to the laboratory test);
  * Creatinine ≤1.5 upper limit of normal (ULN);
  * Total bilirubin ≤1.5 ULN;
  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3ULN, ≤ 5ULN for patients with liver metastases;
  * Coagulation: prothrombin time (PT) and International Normalization Ratio (INR) ≤1.5ULN；
* Female patients must have a urine or blood human chorionic gonadotropin（HCG） negative test before enrolment (except for menopause and hysterectomy); Patients and their partners must agree to use effective contraceptives measures during the study until 6 months after the end of the last dose.

Exclusion Criteria:

* History of severe allergy to mitoxantrone hydrochloride or liposomal drugs; allergy to capecitabine or any excipients of its components; previous serious and unexpected reaction to fluoropyrimidine or known allergy to fluorouracil; known complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity; allergy to paclitaxel or human albumin;
* Cerebral or meningeal metastases;
* Life expectancy \< 3 months;
* Patients with chronic hepatitis B (HBsAg or HBcAb positive with HBV DNA ≥ 2000 IU/mL), chronic hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection of the study center), or human immunodeficiency virus (HIV) antibody positive;
* Active bacterial, fungal or viral infections that require intravenous infusion treatment within 1 week prior to the first dose;
* Any anticancer treatment within 4 weeks prior to the first dose (e.g., radiotherapy, targeted therapy, immunotherapy, endocrine therapy, etc.); Traditional Chinese medicine or proprietary Chinese medicine with an approved oncology indication within 2 weeks prior to the first dose;
* Enrolled in any other clinical trials within 4 weeks prior to the first dose;
* Patients have undergone major surgery within 3 months prior to the first dose, or have a surgical schedule during the study period;
* Serious thrombosis or thromboembolism as judged by the investigator within 6 months prior to screening;
* History of additional malignant tumor within 3 years, except for locally curable cancer that has been cured, such as basal or squamous cell skin cancer or in situ prostate, cervical or breast cancer;
* Patients with the following cardiac function defects:

  * Long QTc syndrome or QTc interval \> 480 ms;
  * Complete left bundle branch block, II-III degree atrioventricular block (except after pacemaker implantation);
  * Severe, uncontrolled arrhythmias requiring pharmacological treatment;
  * History of chronic congestive heart failure, NYHA grade III\~IV;
  * Cardiac ejection fraction \< 50% within 6 months prior to screening;
  * Severe heart valve disease (regurgitation or stenosis) requiring medical treatment
  * Uncontrollable hypertension (defined as a measured systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under pharmacological control);
  * ECG evidence of myocardial infarction, unstable angina, history of severe pericardial disease, and acute ischemic or severe conduction system abnormalities within 6 months prior to screening;
* Lactating female;
* Significant gastrointestinal disease during screening, which may affect the intake, transportation or absorption of drugs (such as inability to swallow, chronic diarrhoea, intestinal obstruction, etc.);
* Patients who diagnosed with peripheral nerve dysfunction affect their daily life；
* Serious and/or uncontrolled medical condition that, in the judgment of the investigator, may affect the patient's participation in this study (including, but not limited to: diabetes not effectively controlled, kidney disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.);
* Not suitable for this study as decided by the investigator due to other reasons.