Clinical trial · Interventional
Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma
An Open-label, Single-arm, Phase II Study to Assess the Efficacy and Safety of Endostar® (Recombinant Human Endostatin Injection) Plus Gemcitabine and Docetaxel in Treatment of Soft Tissue Sarcoma Patients With Pulmonary Metastases
- 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)
The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Endostar | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostar
- description
- Endostar, Gemcitabine, Docetaxel
- interventionNames
- Drug: Endostar
- Drug: Gemcitabine
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Time-to-Progression
- timeFrame
- Approximately 2 years
- description
- Time to progression is defined as time from first study treatment dose to the progression disease.
Secondary outcomes (3)
- measure
- Overall Response Rate
- timeFrame
- Approximately 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18-70 years, male or female. * ECOG performance status \<=2. * Life expectancy \>= 3 months. * Histologically or cytologically confirmed soft tissue sarcoma (GIST excluded). * Patients must have had a prior anthracycline and/or ifosfamide in either the adjuvant or metastatic setting but not more than one regimen. * At least one measurable pulmonary metastasis tumor lesions according to RECIST 1.1 criteria. * Laboratory values: Hemoglobin (Hb) \>= 90 g/L and no blood transfusion within 14 days, Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L, Platelet (Plt)\>= 80 x 10\^9/L, Total Bilirubin (Tbil)=\< 1.5 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN or =\< 5 x ULN if liver metastases are present, Serum creatinine (Cr) =\< 1.0 x ULN, Endogenous creatinine clearance (Ccr)\> 50 mL/min (Cockcroft-Gault). * Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and be willing to use effective contraception during study and for 8 weeks after last IMP administration. * Willingness to participate in study and sign informed consent form. Exclusion Criteria: * Females who are pregnant or breastfeeding or have Childbearing potential unwilling to use effective contraception. * Prior therapy with Gemcitabine, Docetaxel and Endostar. * Subjects participating in other clinical trials within 4 weeks before enrollment. * Accompanied by rapid progress of organ invasions, e.g.lesion areas are great than one half of liver or lung or have liver dysfunction. * Uncontrolled central nervous system disorder or psychiatric illness. * Current, serious, clinically significant cardiac arrhythmias, symptomatic congestive heart failure, myocardial infarction before enrollment. * Patients with abnormal bone marrow function: ANC \< 1.5 x 10\^9/L, Plt \< 75 x 10\^9/L, Hb \< 90g/L. * Patients with renal dysfunction: Cr \> 1.5 x ULN. * Patients with liver dysfunction: Tbil \> 1.5 x ULN. * Uncontrolled brain metastases. * Unwillingness or inability to comply with the study protocol.
References
Publications (0)
Data not yet available