---
title: A Phase II Study of Apatinib in STS Patients
nct_id: NCT03064243
overall_status: UNKNOWN
phase: PHASE2
sponsor: "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"
study_type: INTERVENTIONAL
primary_condition: Soft Tissue Sarcoma
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03064243.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03064243"
ct_last_update_post_date: 2017-02-27
last_seen_at: "2026-05-12T07:34:23.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Phase II Study of Apatinib in STS Patients

**Official Title:** Effectiveness and Safety of Apatinib for the Patients With Advanced Soft Tissue Sarcoma

**NCT ID:** [NCT03064243](https://clinicaltrials.gov/study/NCT03064243)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 53
- **Lead Sponsor:** Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- **Conditions:** Soft Tissue Sarcoma
- **Start Date:** 2017-03-01
- **Completion Date:** 2018-09-01
- **CT.gov Last Update:** 2017-02-27

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **apatinib group** (EXPERIMENTAL) — apatinib 500mg po qd

## Interventions

- **apatinib** (DRUG) — apatinib 500mg po. qd.

## Primary Outcomes

- **6 months PFS rate** _(time frame: From baseline to 6 months)_ — Analyse PFS rate at 6 months

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03064243.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03064243*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*