Albumin-bound Paclitaxel Plus Camrelizumab for Advanced Soft Tissue Sarcoma.
Status:
Recruiting
Trial end date:
2023-07-31
Target enrollment:
Participant gender:
Summary
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.