NCT05189483

Albumin-bound Paclitaxel Plus Camrelizumab for Advanced Soft Tissue Sarcoma.

Albumin-bound Paclitaxel Plus Camrelizumab Therapy in Locally Unresectable or Metastatic Soft Tissue Sarcomas After Failure of First Line Chemotherapy: a Single Institution, Open-label, Phase 2 Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events. The primary end point was progression-free survival at 4 months. Secondary objectives were objective response rate and safety.

Detailed description

There is increasing evidence that combination therapy with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and programmed cell death protein 1 (PD-1) inhibitor is safe and efficacious in treating many types of malignant tumors. However, clinical data demonstrating the effect of this treatment combination for patients with metastatic soft tissue sarcoma are currently limited. In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events. The primary end point was progression-free survival at 4 months. Secondary objectives were objective response rate and safety.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Albumin-Bound Paclitaxel	Enrolled patients will receive 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
DRUG	Camrelizumab	Enrolled patients will receive the following treatment: 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2022-01-12
• Last updated: 2024-02-07

Locations

1 site across 1 country: China