A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma

Study Overview
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Brief Summary
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This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma.

Detailed Description
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This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma. At least 30 subjects will be recruited in this study. The subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle). All patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles).

Official Title
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A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Gastric Carcinoma

Conditions
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Advanced Gastric Carcinoma

Intervention / Treatment
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* Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects fully understand and voluntarily participate in this study and sign informed consent; Age ≥18, without gender limitation; Histologically confirmed diagnosis of unresectable locally advanced or metastatic gastric carcinoma, including gastroesophageal junction carcinoma; Suitable to receive the study drug as decided by the investigator; At least one measurable lesion according to RECIST v1.1; ECOG performance status of 0 to 2; Life expectancy ≥ 12 weeks; AEs from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as hair loss, hyperpigmentation); Adequate organ function; Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment; Fully comply with the protocol. Exclusion Criteria: History of allergy to mitoxantrone hydrochloride or any excipients of the study drug; Untreated or symptomatic central nervous system (CNS) metastases; Amenable to curative surgery ( radical excision); Pleural effusion, pericardial effusion or peritoneal effusion with overt clinical symptoms (except for those have a drainage within 1 month before screening, asymptomatic and the effusion only detectable by imageological examination); Intestinal obstruction with overt clinical symptom and requiring treatment; CTCAE Grade 3 or Grade 4 gastrointestinal hemorrhage within 12 weeks prior to the first dose administration; History of allotransplantation; Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection; Serious infection or interstitial pneumonia within 1 week prior to the first dose administration; Use of other anticancer treatment within 4 weeks prior to the first dose administration; Enrolled in any other clinical trails and had recieved treatment within 4 weeks prior to the first dose administration; Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period; Thrombosis or thromboembolism within 6 months prior to screening; History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ; Impaired cardiac function or serious cardiac disease; Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2. Pregnant or lactating female; Serious and/or uncontrolled systemic diseases;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitoxantrone Hydrochloride Liposome Injection<br>Subjects with advanced gastric carcinoma will receive 20mg/m2Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles. | Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection<br>* All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events (AEs) | The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs). | From the initiation of the first dose to 28 days after the last dose, assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate (ORR) | To investigate the preliminary antitumor efficacy | From the enrollment to the final documentation of response of the last subject (assessed up to 36 months) | 
| duration of response (DoR) | To investigate the preliminary antitumor efficacy | From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months | 
| duration of complete response (DCR) | To investigate the preliminary antitumor efficacy | From the enrollment to the final documentation of response of the last subject (assessed up to 36 months) | 
| progression-free survival (PFS) | To investigate the preliminary antitumor efficacy | From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months | 
| overall survival (OS) | To investigate the preliminary antitumor efficacy | From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months |