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Spots Global Cancer Trial Database for Albumin-bound Paclitaxel Plus Camrelizumab for Advanced Soft Tissue Sarcoma.

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Trial Identification

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

Official Title: 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

Study ID: NCT05189483

Study Description

Brief 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.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Bone and Soft Tissue, Henan Cancer Hospital, Zhengzhou, Henan, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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