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The Combination of Sintilimab and AI (Doxorubicin, ADM/Ifosfamide, IFO) for the First Line Treatment of Select Type of Metastatic/Unresectable Soft Tissue Sarcoma

NCT04356872 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-07-14

No results posted yet for this study

Summary

This is a phase II trial to explore the feasibility of PD-1 immune check point inhibitor, sintilimab, in combination of stand of care chemotherapy in first-line treatment of selected soft tissue sarcoma.

Conditions

  • Sarcoma, Soft Tissue

Interventions

DRUG

Sintilimab

immune check point inhibitor, 200mg, iv, d1

DRUG

Doxorubicin Hydrochloride

ADM, 60mg/m2, iv, d1

DRUG

Ifosfamide

IFO, 1.8 g/m2/d, d1-5

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Xijing Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-08
Primary Completion
2022-03-30
Completion
2023-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356872 on ClinicalTrials.gov