NCT04859465

Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma

Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma--an Open, Single Arm, Multicenter Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to explore the efficacy and safety of the combination of albumin-bound paclitaxel and liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma.

Detailed description

Soft tissue sarcoma (STS) is a relatively rare malignant tumor. In recent years, the disease has been increasing gradually. As an important biological feature of soft tissue sarcoma is local recurrence and distant metastasis, most patients die of distant metastasis. Despite the improvement of local control rate, more than 50% of patients died of unresectable or distant metastasis due to tumor progression. Doxorubicin and ifosfamide based chemotherapy is the standard first-line treatment for patients with relapsed / distant metastasis / unresectable advanced soft tissue sarcoma. For patients who fail or cannot tolerate first-line treatment, the choice of treatment is still limited. At present, some clinical patients who failed to receive standard treatment have tried to use the albumin-bound paclitaxel and liposomal doxorubicin regimen, with the ORR of 33% and PFS of about 8 months. As a new combination of chemotherapy drugs, more targeted phase II clinical studies are needed to evaluate the efficacy and safety of the new chemotherapy drugs in a variety of cancer species. In view of the above problems, this study aims to observe and explore the efficacy and safety of the combination of albumin-bound paclitaxel (keaili) and liposomal doxorubicin (duomeisu) in the treatment of advanced angiogenic sarcoma patients, and to provide better treatment options for patients with advanced sarcoma.

Conditions

• Angiosarcoma Metastatic

Interventions

Type	Name	Description
DRUG	Abraxane combined with liposomal doxorubicin	Patients with advanced or unresectable angiogenic sarcoma who met the criteria of treatment failure received abraxane combined with liposomal doxorubicin regimen. Administration regimen: abraxane 220 mg / m2 D1 plus liposomal doxorubicin 35 mg / m2 D1, IV drip, 3 weeks as a cycle, until the disease progression or intolerable toxicity. Up to 8 cycles.

Timeline

• Start date: 2021-05-21
• Primary completion: 2024-05-20
• Completion: 2024-11-20
• First posted: 2021-04-26
• Last updated: 2023-12-27

Locations

1 site across 1 country: China