NCT05774275View on ClinicalTrials.gov

The Combination of Radiotherapy, Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 25, 2022

Primary Completion Date

August 24, 2024

Study Completion Date

August 24, 2029

Conditions
High-Risk Localized Soft Tissue Sarcoma
Interventions
DRUG

Pegylated Liposomal Doxorubicin

In phase Ib: 37.5 mg/m2, 30 mg/m2, d1, q3w; In phase II: recommended phase 2 dose (RP2D), d1, q3w.

DRUG

Doxorubicin

75mg/m2, d1, q3w Doxorubicin hydrochloride will be administered if subject is allergic to Doxil.

DRUG

Anti-PD-1 monoclonal antibody

200 mg, d1, q3w

RADIATION

Radiotherapy

BED=50-60Gy(α/β=10); Radiation dose depends on tumor characteristics and organs at risk.

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER