Trials / Unknown
UnknownNCT04356872
The Combination of Sintilimab and AI (Doxorubicin, ADM/Ifosfamide, IFO) for the First Line Treatment of Select Type of Metastatic/Unresectable Soft Tissue Sarcoma
A Single Arm, Multi Centers, Phase II Study of Sintilimab, Doxorubicin and Ifosfamide at First-line Treatment of Soft Tissue Sarcoma Including Undifferentiated Pleomorphic Sarcoma, Synovial Sarcoma, Myxoid Liposarcoma and De-differentiated Liposarcoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-04-08
- Primary completion
- 2022-03-30
- Completion
- 2023-03-30
- First posted
- 2020-04-22
- Last updated
- 2020-07-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04356872. Inclusion in this directory is not an endorsement.