NCT03121833

Endostar Combined With Chemotherapy for Stage Ⅳ Soft Tissue Sarcoma

Randomized, Double-blind, Placebo-controlled (2: 1), Multicenter Clinical Study (IIB) for the Treatment of Stage Ⅳ Soft Tissue Sarcoma With Recombinant Human Endostatin(Endostar) Combined With Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled (2: 1), multicenter clinical phase II clinical trial evaluating the efficacy and safety of Endostar combined with chemotherapy for stage IV soft tissue sarcoma.

Detailed description

The prognosis of sarcoma patients in stage IV is poor. For STS, the response rate of chemotherapy is only 20-35% and the median survival time is about 12 months. The 5 year survival rate is lower than 10% reported in several large-scale studies. Although chemotherapy plays a major role in the treatment of advanced STS, the classic chemotherapy agents are not curative. Combination chemotherapy or dose-dense regimens have largely failed to improve the response rates. Long-term using of cytotoxic drugs increased the risk of toxicity in patients. Endostatin is the strongest endogenous angiogenesis inhibitor, which inhibits vascular endothelial growth factor (VEGF) expression and then inhibits tumor angiogenesis . Endostar, is a novel recombinant human endostatin, with advantages of long half-life, stable and low cost. Recently, a study of Endostar combined with chemotherapy in the treatment of advanced soft tissue sarcoma indicated resulted in a higher clinical benefit response (CBR) and longer progression-free survival (PFS), with tolerable side effects. However this study included the patients with stage IIB-IV soft tissue sarcomas and did not include specific pathologic information. Thus this clinical trial is designed to compare the efficacy and safety of endostar combined with chemotherapy versus chemotherapy alone in stage IV patients with soft tissue sarcomas.

Conditions

• Soft Tissue Sarcoma, Adult, Stage IIB

Interventions

Type	Name	Description
DRUG	Endostar	Recombinant Human Endostatin Injection
DRUG	Placebo	500ml 0.9% sodium chloride
DRUG	AIM regimen / GT regimen	"Pirarubicin (THP) + Ifosfamide (IFO)" / "Docetaxel (TXT) + Gemcitabine (GEM)"

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2017-04-20
• Last updated: 2019-12-26

Locations

1 site across 1 country: China