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A phase I study for dose escalation of polyethylene glycol modified liposome adriamycin combined with cisplatin in the treatment of advanced osteosarcoma

A phase I study for dose escalation of polyethylene glycol modified liposome adriamycin combined with cisplatin in the treatment of advanced osteosarcoma

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021550
Enrollment
Unknown
Registered
2019-02-27
Start date
2018-12-01
Completion date
Unknown
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteosarcoma

Interventions

Case series:Polyethylene glycol modified liposome doxorubicin combined with cisplatin

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 14-60 years old; 2. ECOG PS score 0-1; 3. metastatic or unresectable osteosarcoma confirmed by histopathology; 4. patients with tumor recurrence and metastasis have not received systemic drug therapy, and those with unresectable initial treatment have not received systemic drug chemotherapy; 5. patients volunteered to participate in this study and signed the informed consent; 6. the expected survival time is no less than 6 months; 7. cardiac function: (1) cardiac color doppler ultrasonography LVEF 50% (2) EKG indicates no myocardial ischemia (3) no history of arrhythmia requiring drug intervention prior to enrollment 8. major organ functions should meet the following standards within 7 days before treatment: (1) blood routine examination standard (without blood transfusion within 14 days) Hemoglobin (HB) 90g/L; the absolute value of neutrophils (ANC) 1.5 10^9/L; Platelet (PLT) 80 10^9/L; (2) biochemical examination shall meet the following standards: total bilirubin (TBIL) 1.5 times the normal value of the upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST acuities were 2.5 ? ULN, such as with liver metastasis, ALT and AST 5 or less ULN; Cr =1.5 ULN or CCr =60ml/min; 9. women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment must be non-lactating;Men should agree to use contraceptives during the study period and within 6 months after the study period. Note: patients with chronic hepatitis b can be enrolled, but need to receive entecavir antiviral treatment

Exclusion criteria

Exclusion criteria: 1. previous or concurrent heart disease, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, arrhythmia (including persistent atrial fibrillation, complete left bundle branch block, frequent ventricular premature); 2. previous history of severe chronic skin diseases; 3. previous allergic asthma or severe allergic diseases; 4. have a history of other tumors, except cervical cancer or basal cell carcinoma of the skin that has been cured 5. symptomatic active bacterial, fungal or viral infection, including but not limited to patients infected with HIV, syphilis or HBV or HCV; 6. pregnant or lactating women; 7. patients who have received organ transplantation in the past; 8. contraindications to the use of large doses of hormones, such as hyperglycemia, gastric ulcers or mental diseases that cannot be controlled by insulin; 9. a history of severe neurological or psychiatric problems, including dementia or epilepsy; 10. the researcher considers that the patient is not fit for other conditions or conditions of this study.

Design outcomes

Primary

MeasureTime frame
maximun tolerated dose, MTD;

Countries

China

Contacts

Public ContactXing Zhang

Sun Yat-sen University CancerCenter

zhangxing@sysucc.org.cn+86 020 87343383

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026