Clinical trial · Interventional
A Phase II Study of Apatinib in STS Patients
Effectiveness and Safety of Apatinib for the Patients With Advanced Soft Tissue Sarcoma
NCT03064243CI-TRIAL-00026171unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Apatinib is a kind of innovative medicines approved by China Food and Drug Administration(CFDA), which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd. Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apatinib group
- description
- apatinib 500mg po qd
- interventionNames
- Drug: apatinib
Primary outcomes (1)
- measure
- 6 months PFS rate
- timeFrame
- From baseline to 6 months
- description
- Analyse PFS rate at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent. * Histologically proven advanced soft tissue sarcoma, At least one measurable lesion. Including: Synovial sarcoma, leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, Angiosarcoma, Spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, Ewing's sarcoma of soft tissue/Primitive neuroectodermal tumor. Excluding: Malignant peripheral nerve sheath tumor, chondrosarcoma, Dermatofibrosarcoma protuberans, Gastrointestinal stromal tumor, Inflammatory myofibroblastic sarcoma, Malignant mesothelioma. * Must have evidence of unresectable residual disease. * In the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment. * ECOG ps≤2. * Life expectancy: more than 3 months. * Prior aptinib less than 2 weeks and at least 1 month since prior aptinib;at least 1 month since prior inhibitor of mTOR or EGFR pathway. * Not pregnant or nursing;Fertile patients must use effective contraception. * Hematopoietic * HB≥90g/L * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 80,000/mm\^3 Exclusion Criteria: * Uncontrollable hypertension; * Has influence of oral drugs; * Patients with high risk of gastrointestinal blooding; * INR\>1.5×ULN,APTT\>1.5×ULN; * Allergic to any ingredient of this product; * Less than 1 month since last major surgery; * Brain metastases; * With the second cancer.
References
Publications (1)
- DERIVEDYu W, Zhang H, Chen J, Zhang X, Chen Y, Qu G, Huang G, Zhou Y, Ye T, Fan Z, Yao Y. Efficacy and safety of apatinib in patients with untreated or chemotherapy-refractory soft tissue sarcoma: a multicenter, phase 2 trial. Ann Transl Med. 2022 Sep;10(18):981. doi: 10.21037/atm-22-4229. PMID 36267741