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Efficacy and safety of Anlotinib plus Epirubicin civ followed by Anlotinib sequential therapy in the first-line chemotherapy for advanced soft tissue sarcoma (STS): A single-arm phase 2 clinical trial

Efficacy and safety of Anlotinib plus Epirubicin civ followed by Anlotinib sequential therapy in the first-line chemotherapy for advanced soft tissue sarcoma (STS): A single-arm phase 2 clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024928
Enrollment
Unknown
Registered
2019-08-03
Start date
2019-08-05
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Sarcoma

Interventions

Case series:An+EPI?An

Sponsors

Zhongshan Hospital ,Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 75 years previously untreated STS patients who lost the chance of radical surgery; 2. Histologically proven STS, but Ewing sarcoma, RMS, WDDLP, WDLPS, ASPS, EMC, CCS were excluded; 3. For recurrence cases, no previous anthracycline-based therapy; 4. Measurable disease according to the RECIST1.1; 5. ECOG/PS 0-1; 6. Estimated survive >=12 weeks. 7. Sufficient bone marrow and organ function; 8. Maintain contraception during the study.

Exclusion criteria

Exclusion criteria: 1. Prior palliative chemotherapy, targeted or other therapy for the advanced STS; 2. Central nervous system metastases; 3. Systemic hormone use, inhalation is not counted; 4. Other malignant cancer in recent 5 years; 5. Serious DM or middle-high organ function impairment; 6. CVD need to interfere or uncontrollable hypertension; 7. Risk of bleeding, obstruction or perforation; 8. Risk of thrombosis or history of thrombosis; 9. Uncontrolled infections; HIV positive; Immunodeficiency; 10. Heart-based disease, including CVD, Myocardial infarction, heart dysfunction, etc.

Design outcomes

Primary

MeasureTime frame
PFR (12weeks & 24 weeks);

Secondary

MeasureTime frame
ORR;PFS;DCR;OS;Safety (according to CTCAE1.1);

Countries

China

Contacts

Public ContactZhou Yuhong

Zhongshan Hospital, Fudan University

zhou.yuhong@zs-hospital.sh.cn+86 13918286810

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026