RecruitingPhase 2NCT04589754

Adriamycin and Ifosfamide Combined With Sintilimab

An Open, Multi-center, Randomized, Phase II Study of Adriamycin and Ifosfamide Combined With Sintilimab in the Treatment of Advanced or Unresectable Soft Tissue Sarcoma


Sponsor

Sun Yat-sen University

Enrollment

176 participants

Start Date

Jul 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study was to explore the efficacy and safety of adriamycin and ifosfamide combined with sintilimab versus chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma.


Eligibility

Min Age: 14 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests two chemotherapy drugs (adriamycin and ifosfamide) combined with an immunotherapy drug called sintilimab for people with advanced or inoperable soft tissue sarcomas — cancers of the body's connective tissues like fat, muscle, or blood vessels — that have not responded to standard treatments or where no standard treatment exists. **You may be eligible if...** - You have advanced or inoperable soft tissue sarcoma confirmed by biopsy - Standard treatment has failed, does not exist, or you cannot tolerate it for your subtype - You have at least one measurable tumor on imaging (CT or MRI) - You are in reasonable overall health and able to tolerate treatment - You are willing to participate and sign the consent form **You may NOT be eligible if...** - Your sarcoma type is specifically excluded (such as chondrosarcoma, osteosarcoma, gastrointestinal stromal tumor, or malignant mesothelioma) - You have no measurable disease on imaging - You have significant heart, liver, or kidney problems that would make chemotherapy unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSintilimab plus chemotherapy

AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; sintilimab (10ml; 100mg) was administered intravenously every 3 weeks.

DRUGAdriamycin-based chemotherapy

AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks.


Locations(1)

Xing Zhang

Guangzhou, Guangdong, China

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NCT04589754


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