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Phase 2 Study of Anlotinib Hydrochloric Capsule in Advanced Soft Tissue Sarcoma

Phase 2
18 Years
70 Years
Open (Enrolling)

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Trial Information

Phase 2 Study of Anlotinib Hydrochloric Capsule in Advanced Soft Tissue Sarcoma

Inclusion Criteria:

- 1.Faild in introditional treatmeat, Mainly includes:MFH/liposarcoma/leiomyosarcoma/SS
and others(MPNST/Fibrosarcoma/CCS/ASPS/AS/ES; 2.Receiveed at least one chemotherapy
regimens treatment; 3.18-70years, ECOG:0-2,Expected survival period >3 months;
4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L;PLT

- 80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase
)≤1.5*ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5*ULN)
;TG≤ 3.0mmol/L,cholesterol≤7.75mmol/L; LVEF

- LLN. 5.Used contraceptive during the study and after 6 months; 6.Volunteer.

Exclusion Criteria:

- 1. Received vascular endothelial growth inhibitor type of targeted therapy; 2.With
the second cancer; 3.Participated in other clinical trials in four weeks; 4.Received
in other radiotherapy or chemotherapy treatment in four weeks; 5.AE>1 6.Has influence
of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis;
8.Any serious or failed to control the disease 9.Artery/venous thrombotic;
10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.Hitory of
psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history;
14.Concomitant diseases.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor size

Outcome Description:

To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT scan every two cycles. Refer to recist 1.1.

Outcome Time Frame:

each 42 days up to 48 months

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

June 2014

Related Keywords:

  • Cancer
  • Sarcoma