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UTD2+ tislelizumab+ doxorubicin

Phase 2

Soft Tissue Sarcoma (STS) | Small Molecules | Oncology |Biostar Pharmaceuticals, Inc.|Trials Updated: Sep 25, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

UTD2+ tislelizumab+ doxorubicin clinical trials

UTD2+ tislelizumab+ doxorubicin · 1 trial · 3 indications

Phase 2 1
NCT07842276Utidelone Capsules Combined With Doxorubicin for Advanced Soft Tissue SarcomaSoft Tissue Sarcoma (STS)
NOT YET_RECRUITING49 Analytics
PHASE2NOT YET_RECRUITING
Utidelone Capsules Combined With Doxorubicin for Advanced Soft Tissue Sarcoma
Soft Tissue Sarcoma (STS)Unlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival, PFS
up to 18 months

time from the first dose to disease progression or any-cause death

Secondary Endpoints

Objective Response Rate (ORR)according to the RECIST 1.1
up to 18 months
Disease Control Rate (DCR)according to the RECIST 1.1
up to 18 months
Duration of response (DoR) according to the RECIST 1.1
up to 18 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
UTD2 + tislelizumab + doxorubicinEXPERIMENTAL -

Interventions

NameTypeDescription
UTD2 + tislelizumab + doxorubicinDRUGUTD2: 60 mg/m²/day, orally administered on an empty stomach on Days 1-5 of each cycle (no food 2 hours before and within 1 hour after taking the medication), once daily. Doxorubicin: 75 mg/m²/day, administered by intravenous infusion on Day 1 of each cycle. Doxorubicin is limited to a maximum of 6 cycles. Tislelizumab: 200 mg, administered by intravenous infusion on Day 1 of each cycle. Treatments were repeated every 3 weeks until disease progression (as assessed by the investigator according to RECIST v1.1), intolerable toxicity, withdrawal of informed consent by the participant, loss to follow-up, study termination, death, or when the investigator deemed it necessary to terminate medication or complete maintenance therapy, whichever occurred first.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Fully understand the purpose, content, process of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form; 2. Age of 18-70 years old (including 18 and 70 years old) at the time of informed consent (ICF) signing, regar...

Countries:China
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