Phase I dose escalation study of liposome doxorubicin combined with ifosfamide in the treatment of advanced soft tissue sarcoma

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900027033

Enrollment

Unknown

Registered

2019-10-29

Start date

2019-11-06

Completion date

Unknown

Last updated

2019-11-04

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

Conditions

soft tissue sarcoma

Interventions

1: liposome doxorubicin combined with ifosfamide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with advanced soft tissue sarcoma who were unsuitable for surgical treatment (diagnosed by pathology or cytology, except for gastrointestinal stromal tumors, embryonic / acinar rhabdomyosarcoma, Ewing's sarcoma, and other types that investigators considered to be unsuitable for AI regimen chemotherapy); 2. Aged >= 18 years; 3. The Eastern Cancer Cooperative Group (ECOG) scores 0-1 for physical status and 2 points for amputees; 4. Expected survival time > 6 months; 5. Sufficient organ and bone marrow functions, defined as follows: 1) Blood routine (no blood transfusion within 14 days before screening, no use of G-CSF, no medication used to correct):ANC >= 1.5x10^9/L; PLT >= 100x10^9/L; Hb >= 100g/L; 2) Blood chemistry:Serum creatinine = 60 ml/ min; total bilirubin (TBil) level = 2+, 24-hour urine protein quantitation showed protein must be = 50%; 7. Withthe patients consent and signed informed consent, willing and able to comply with planned visits, research treatments, laboratory tests and other testing procedures.

Exclusion criteria

Exclusion criteria: 1. Patients had a total cumulative dose of anthracycline treatment exceeded the equivalent doxorubicin 360mg/m2; 2. The New York Heart Association (NYHA) graded class II heart disease patients (including grade II) previous or current,or LVEF = 38.0 degree C; 8. Pregnant or lactating women,or patients who plan to become pregnant during the study period or within one year of the last use of the study drug; 9. Researchers think it is not suitable for enrolling that patients who participate in the trial do not meet the best interests of the subject (such as harm to their health) or who would interfere with any of the trial evaluations.

Design outcomes

Primary

Measure	Time frame
maximun tolerated dose, MTD;	—

Secondary

Measure	Time frame
safety;	—

Countries

China

Contacts

Public ContactJing Chen

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

chenjingunion@163.com+86 027 85873501

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026