Sarcoma, Soft TissuePhase 2NCT04356872
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 Phase 2 study testing Sintilimab, Doxorubicin Hydrochloride and Ifosfamide in people with Sarcoma, Soft Tissue, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Sintilimab, Doxorubicin Hydrochloride and Ifosfamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2020to 30 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-75 years;
- Provide written informed consent;
- Local advanced or metastatic unresectable sarcoma;
- Histologically confirmed undifferentiated pleomorphic sarcoma, synovial sarcoma, de-differentiated liposarcoma and myxoid liposarcoma;
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale;
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
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- Life span expectation over 3 months
- Absolute neutrophil count (ANC) ≥1,500/mcL (within 7 days of treatment initiation) ；
- Hemoglobin ≥9 g/dL (within 7 days of treatment initiation) ；
- Platelets ≥ 90,000/mcL (within 7 days of treatment initiation) ；
- Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or creatinine clearance [CrCl]) ≥ 50 mL/min for subject with creatinine levels (within 7 days of treatment initiation) ；
- Serum total bilirubin ≤ 1.5 X ULN (within 7 days of treatment initiation) ；
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 X ULN or =< 5 X ULN for subjects with liver metastases (within 7 days of treatment initiation)；
Who cannot join
- Prior systemic therapy for advanced and metastatic disease, except adjuvant treatment（not received anthracycline）replase over 6 months;
- Received any testing anti-cancer drugs within four weeks of treatment initiation;
- Prior immune related therapy including but not limited to PD-1, PD-L1, CD137, CTLA4, T cell stimulation, check point inhibitor etc;
- Symptomatic, untreated, or uncontrolled brain metastases present
- clinical meaningful active bleeding;
- Other malignant cancer history rather than soft tissue sarcoma within five year prior to treatment initiation;
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- Have active infections requiring therapy;
- Have active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study.
- Pregnant or breast-feeding；
- Any serious or unstable medical condition or mental illness；
- Serious systemic diseases such as heart disease, history of (non-infectious) pneumonitis;
- Active HBV （>10000 copy/ml） and HCV （RNA> 1000copy/ml） infection；
- Positive human immunodeficiency virus (HIV）or any acquired immunodeficiency syndrome, organ implantation;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University, Cancer Hospital
Shanghai, Shanghai Municipality, 200000
Xin Liu, MD, 0086-18017317720, jeanettexin@hotmail.com
About this study
Official title: 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
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
- Being tested
- Sintilimab, Doxorubicin Hydrochloride, Ifosfamide
- Keywords
- PD-1, doxorubicin, ifosfamide, first line treatment
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
immune check point inhibitor, 200mg, iv, d1
Also called ADM
ADM, 60mg/m2, iv, d1
IfosfamideDrug
Also called IFO
IFO, 1.8 g/m2/d, d1-5
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sintilimab; Drug: Doxorubicin Hydrochloride; Drug: Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate, ORR
the best response rate
Measured: up to two years
Secondary outcomes (3)
progression free survival, PFS
from first dose treatment to disease progression
Measured: up to three years
adverse events, AE
treatment related adverse events, TRAEs
Measured: up to three years
overall survival, OS
overall survival
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start8 Apr 2020
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Tongji Hospital, Xijing Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356872
- Sponsor's protocol ID
- SAIS
- Status last verified
- Jul 2020
- First submitted
- 17 Apr 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decide, need to discuss with all collaborators
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04356872
- Acronym / sponsor ID
- SAIS
- Conditions
- Sarcoma, Soft Tissue
- Keywords
- PD-1, doxorubicin, ifosfamide, first line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Tongji Hospital, Xijing Hospital, Shanghai Zhongshan Hospital
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Sintilimab, Drug: Doxorubicin Hydrochloride, Drug: IfosfamideThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men and women aged 18-75 years;
- Provide written informed consent;
- Local advanced or metastatic unresectable sarcoma;
- Histologically confirmed undifferentiated pleomorphic sarcoma, synovial sarcoma, de-differentiated liposarcoma and myxoid liposarcoma;
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale;
Key exclusion criteria (13 listed)
- Prior systemic therapy for advanced and metastatic disease, except adjuvant treatment（not received anthracycline）replase over 6 months;
- Received any testing anti-cancer drugs within four weeks of treatment initiation;
- Prior immune related therapy including but not limited to PD-1, PD-L1, CD137, CTLA4, T cell stimulation, check point inhibitor etc;
- Symptomatic, untreated, or uncontrolled brain metastases present
- clinical meaningful active bleeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimabimmune check point inhibitor, 200mg, iv, d1 | Drug | treatment |
| Doxorubicin HydrochlorideAlso: ADMADM, 60mg/m2, iv, d1 | Drug | treatment |
| IfosfamideAlso: IFOIFO, 1.8 g/m2/d, d1-5 | Drug | treatment |
Primary outcome
overall response rate, ORR
Time frame: up to two years
the best response rate
3 secondary outcomes
progression free survival, PFS
Time frame: up to three years
adverse events, AE
Time frame: up to three years
overall survival, OS
Time frame: up to three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Undecided. not yet decide, need to discuss with all collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab, Doxorubicin Hydrochloride and Ifosfamide in people with Sarcoma, Soft Tissue, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Liu, MD (0086-021-64175590, jeanettexin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate, ORR (time frame: up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.