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| Name | Class |
|---|---|
| Zhejiang Cancer Hospital | OTHER |
| Tongji Hospital | OTHER |
| Xijing Hospital | OTHER |
| Shanghai Zhongshan Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | The patients with metastatic and unresectable soft tissue sarcoma including undifferentiated pleomorphic sarcoma, synovial sarcoma, de-differentiated liposarcoma and myxoid liposarcoma will be enrolled and given sintilimab (PD-1) , doxorubicin and doxorubicin every three weeks for 6 cycles followed by sintilimab mono therapy till disease progression. The first enrolled six patients is safety run-in step for observing drug-limiting toxicity (DLTs). If the combinatory treatment is intolerable, the doses of chemo regimens will be reduced according to drug instruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | immune check point inhibitor, 200mg, iv, d1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate, ORR | the best response rate | up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival, PFS | from first dose treatment to disease progression | up to three years |
| adverse events, AE | treatment related adverse events, TRAEs |
| Measure | Description | Time Frame |
|---|---|---|
| PD-L1 expression | PD-L1 expression will be detected by Immunohistologic chemistry, IHC or PCR method | up to two years |
| tumor infiltrating lymphocytes measurement | tumor infiltrating lymphocytes will be measured by flowcytometry using tissue and/or peripheral blood sampleï¼› |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Liu, MD | Contact | 0086-021-64175590 | jeanettexin@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University, Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
not yet decide, need to discuss with all collaborators
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| OTHER |
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| Doxorubicin Hydrochloride |
| Drug |
ADM, 60mg/m2, iv, d1 |
|
|
| Ifosfamide | Drug | IFO, 1.8 g/m2/d, d1-5 |
|
|
| up to three years |
| overall survival, OS | overall survival | up to three years |
| up to two years |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D004317 | Doxorubicin |
| D007069 | Ifosfamide |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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