| Eligibility |
Inclusion Criteria:
1. Patients fully understand and voluntarily participate in this study and sign informed
consent;
2. Aged 18-75 years (inclusive), without gender limitation;
3. Histologically or cytologically confirmed advanced pancreatic tumors;
4. Patients with locally progressive or metastatic pancreatic cancer who have disease
progression after receiving first line or above standard treatment.
5. At least one measurable lesion according to RECIST v1.1 at baseline;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
7. Adequate organ function defined as (No G-CSF treatment or blood transfusion within 2
weeks prior to the first dose):
- Absolute neutrophil count (ANC) =1.5*10^9/L;
- Hemoglobin = 90 g/L;
- Platelet count = 100 * 10^9/L;
- Creatinine =1.5 * upper limit of normal (ULN);
- Total bilirubin =2 * ULN;
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 3 * ULN
(= 5 * ULN in patients with hepatic metastasis);
- Coagulation: prothrombin time (PT) or International Normalization Ratio (INR)
=1.5 * ULN.
8. Female patients must have a urine or blood HCG negative test before enrolment (except
for menopause and hysterectomy); Patients and their partners must agree to use
effective contraceptive measures during the study until 6 months after the end of the
last dose.
9. Good compliance and willingness to cooperate with follow-up visits.
Exclusion Criteria:
1. History of severe allergy to mitoxantrone hydrochloride or any excipients of the study
drug;
2. History of other malignant tumor in previous 3 years, not including cured cervical
carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma.
3. Cerebral or meningeal metastases;
4. Patients with chronic hepatitis B (HBsAg 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;
5. Life expectancy < 3 months;
6. Previous treatment with adriamycin or other anthracyclines, with the total cumulative
dose (doxorubicin equivalent) >350 mg/m^2;
7. AEs from the previous treatment have not resolved to = Grade 1 based on CTCAE (except
for the toxicity without safety risk judged by the investigator, such as alopecia,
hyperpigmentation);
8. 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;
- Severe, uncontrolled arrhythmias requiring pharmacological treatment;
- History of chronic congestive heart failure, NYHA = grade 3;
- Cardiac ejection fraction < 50% within 6 months prior to screening;
- Heart valve disease with CTCAE = grade 3;
- History of myocardial infarction, unstable angina, severe ventricular
arrhythmias, severe pericardial disease, or ECG evidence of acute ischemic or
active conduction system abnormalities within 6 months prior to screening;
9. Uncontrollable hypertension (defined as a measured systolic blood pressure = 160 mmHg
or diastolic blood pressure = 100 mmHg under pharmacological control);
10. Malignant serous cavity effusion (e.g. pleural effusion, pericardial effusion,
ascites);
11. Active bacterial, fungal or viral infections requiring intravenous infusion treatment
within 1 week prior to the first dose;
12. 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;
13. Enrolled in any other clinical trials within 4 weeks prior to the first dose;
14. Patients underwent major surgery within 12 weeks prior to the first dose, or have a
surgical schedule during the study period;
15. Having a schedule of other anti-cancer treatment during the study period.
16. Deep vein thrombosis or arterial embolism within the previous 6 months, including but
not limited to superior/inferior vena cava thrombosis, lower limb deep vein
thrombosis, pulmonary embolism;
17. Lactating female;
18. 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, neurological
disorders, etc.);
19. Not suitable for this study as decided by the investigator due to other reasons.
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