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Locally Advanced AngiosarcomaPhase 2NCT05026736

Sintilimab for the Treatment of Locally Advanced, Metastatic, or Recurrent Angiosarcoma, the SiARa Cancer Study

A Phase 2 study testing Quality-of-Life Assessment and Sintilimab in people with Locally Advanced Angiosarcoma and Metastatic Angiosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial evaluates the effect of sintilimab in treating patients with angiosarcoma that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or has come back (recurrent). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Quality-of-Life Assessment and Sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
23 Aug 2021to 12 Aug 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic angiosarcoma
  • Intolerant to or progressed on at least one line of systemic chemotherapy. Patient ineligible for cytotoxic chemotherapy are eligible
  • Aged >= 18
  • Can provide archival or fresh tissues for optional correlative analysis
  • Have at least one measurable lesion as per RECIST version (v)1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
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  • Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
  • Platelet (PLT) count >= 75 x 10^9/L
  • Hemoglobin (HGB) >= 8.0 g/dL
  • Total bilirubin (TBIL) =< 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN in subjects without hepatic metastasis; ALT and AST =< 5 x ULN in subjects with hepatic metastasis, gamma-glutamyl transferase (GGT) =< 10 x ULN
  • Urine protein < 2+ from random sample or < 1 g from 24-hour urine collection
  • Serum creatinine =< 1.5 x ULN or calculated creatinine clearance rate (Ccr) >= 50 mL/min by Cockcroft-Gault formula
  • Adequate coagulation function, defined as international normalized ratio (INR) =< 1.5 or prothrombin time (PT) =< 1.5 x ULN; if the subject is receiving anticoagulant therapy, the results of coagulation tests need to be within the acceptable range for anticoagulants
  • Expected survival >= 12 weeks
  • Subject (female subjects of childbearing age or male subjects whose partners are of childbearing age) must take effective contraceptive measures during the entire course of the trial and until 180 days after the last dose
  • Signed the informed consent form (ICF) and be able to comply with the scheduled follow-up visits and related procedures required in the protocol

Who cannot join

  • Received treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways
  • Enrolled in another interventional clinical study for angiosarcoma, unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study
  • Received palliative radiation therapy for local lesion within 2 weeks prior to the first dose
  • Received systemic treatment with anti-cancer indications or immunomodulators (including thymosins, interferons, and interleukins) within 2 weeks prior to the first dose of study treatment
  • Received systemic immunosuppressants within 2 weeks prior to first dose, excluding local use of glucocorticoids administered by nasal, inhaled, or other routes, and systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone or equivalents), or glucocorticoids to prevent allergies to contrast media
  • Received a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or be scheduled to receive live attenuated vaccine during the study period
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  • Note: Seasonal inactivated influenza virus vaccines within 4 weeks prior to the first dose of study treatment are permitted, but attenuated influenza vaccines are not
  • Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment or is scheduled to receive major surgery during the course of the trial
  • Any toxicity (excluding alopecia, events that are not clinically significant, or asymptomatic laboratory abnormalities) due to prior anti-tumor therapy that has not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grade 0 or 1 prior to the first dose of study treatment
  • Known symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis. Subjects with brain metastases who have received prior treatment can be enrolled if the disease is stable (no imaging evidence of progressive disease [PD] for at least 4 weeks prior to the first dose of study treatment), there is no evidence of new brain metastases or progression of the existing metastatic lesion(s) upon repeated imaging, and corticosteroids have not been required for at least 14 days prior to the first dose of study treatment. Patients with carcinomatous meningitis are ineligible, regardless of whether the disease is clinically stable or not
  • Subjects with bone metastases at risk of paraplegia
  • Known active autoimmune disease requiring treatment or previous disease history within 2 years (subjects with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment, hypothyroidism only requiring thyroid replacement, or type I diabetes only requiring insulin can be enrolled)
  • Known history of primary immunodeficiency diseases
  • Known active pulmonary tuberculosis
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Human immunodeficiency virus (HIV)-infected subjects (positive anti-HIV antibody)
  • Active or poorly controlled serious infections that require systemic therapy
  • Symptomatic congestive heart failure (New York Heart Association [NYHA] class II-IV) or symptomatic or poorly controlled arrhythmia
  • Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) despite of standard treatment
  • Any arterial thromboembolic event within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accident, or transient cerebral ischemic attack
  • Significant malnutrition, such as those requiring continuous parenteral nutrition >= 7 days; excluding those having received intravenous treatment for malnutrition for more than 4 weeks before the first dose of study treatment
  • History of clinically significant deep venous thrombosis, pulmonary embolism, or other serious thromboembolic events within 3 months prior to enrollment (implantable port or catheter-related thrombosis or incidental pulmonary embolism [PE] detected on scan without symptoms or superficial venous thrombosis are not considered as "serious" thromboembolisms)
  • Uncontrolled metabolic disorders, non-malignant organ or systemic diseases, or cancer-related secondary diseases that may lead to higher medical risks and/or survival evaluation uncertainties
  • Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis with Child-Pugh class B or C
  • Bowel obstruction or history of the following diseases: inflammatory bowel disease, extensive bowel resection (partial colectomy or extensive small intestine resection accompanied with chronic diarrhea), Crohn's disease, or ulcerative colitis
  • Known acute or chronic active hepatitis B (positive hepatitis B surface antigen [HBsAg] and hepatitis B virus [HBV] deoxyribonucleic acid [DNA] viral load >= 10^4 copies/mL or > 2000 IU/mL), or acute or chronic active hepatitis C (hepatitis C virus [HCV] ribonucleic acid [RNA] >10^3 copies/mL), or simultaneously positive for HBsAg and HCV antibody
  • History of gastrointestinal (GI) perforation and/or fistula within 6 months prior to the enrollment, excluding gastrostomy or enterostomy
  • Interstitial lung disease requiring corticosteroids
  • History of other primary malignant tumors, excluding:
  • Malignant tumors that achieved a complete response (CR) at least 2 years prior to enrollment and expected to require no treatment during the trial
  • Adequately treated nonmelanoma skin cancer or lentigo maligna with no sign of disease recurrence
  • Adequately treated carcinoma in situ with no sign of disease recurrence
  • Prostate, chronic lymphocytic leukemia (CLL) or other cancers where the indolent nature of tumor allows for and patient is cancer under active surveillance
  • Pregnant or breastfeeding female subjects
  • Acute or chronic diseases, psychiatric disorders, or laboratory abnormalities that may lead to the following consequences: increased investigational drug-related risks, interference with interpretation of trial results, or considered ineligible for participating in the trial by the investigators
  • If there are any uncertainties regarding the inclusion/exclusion, please contact the sponsor immediately and provide a complete medical history of the subject. The sponsor and principal investigator will discuss and determine the eligibility of the subject

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab for Angiosarcoma

This phase II trial evaluates the effect of sintilimab in treating patients with angiosarcoma that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sintilimab may help to control angiosarcoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the efficacy of sintilimab in subjects with angiosarcoma (progression- free rate PFR at 9 cycles by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).

SECONDARY OBJECTIVE:

  1. To evaluate the objective response rate (ORR), stable disease rate (SDR), progression free survival (PFS), overall survival (OS), quality of life (QOL), safety and duration of response (DOR) of sintilimab in subjects with angiosarcoma.

EXPLORATORY OBJECTIVES:

  1. To evaluate the correlation between biomarkers in tumor tissue and efficacy, including but not restricted to PD-L1 expression level, transcriptome sequencing, single-cell sequencing, and multicolor immunohistochemistry (IHC) analyses.

II. To evaluate the correlation between biomarkers in peripheral blood and efficacy, including but not restricted to soluble PD-L1, circulating tumor deoxyribonucleic acid (DNA) (ctDNA), and cytokine analyses.

OUTLINE:

Patients receive sintilimab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue to receive treatment at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 30 and 90 days, and then every 60 days for up to 3 years.

Being tested
Quality-of-Life Assessment, Sintilimab
Medical subject headings
Hemangiosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • SintilimabBiological

    Also called Anti-PD-1 Monoclonal Antibody IBI308, Anti-PDCD1 Monoclonal Antibody IBI308, IBI 308, IBI308

    Given IV

Study groups in NCT05026736
Study groupRoleWhat they receive
Treatment (sintilimab)ExperimentalPatients receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue to receive treatment at the discretion of the treating physician.
Receives: Other: Quality-of-Life Assessment; Biological: Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Rate at 9 Cycles

    A patient was considered as a responder to the treatment if he/she had no confirmed progressive disease determined by RECIST 1.1 after 9 cycles of therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addtion, the sum must also demonstrate an absolute increaase of at least 5 mm. (Note: the appearmance of one or more new lesions is also considered progression).

    Measured: Nine cycles of therapy (Each cycle consists of a 21-day period)

Secondary outcomes (6)

  1. Objective Response Rate (Complete Response + Partial Response)

    Objective response rate is defined as percentage of participants who have achieved a complete response or particial response per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1). Complete response is defined as disapperance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response is defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: up to 3 years

  2. Duration of Response

    Duration of response (DOR) was measured from the time measurement criteria were first met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded on study). Using RECIST v1.1, CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD is defined as a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearmance of one or more new lesions is also considered progression).

    Measured: Up to 3 years

  3. Progression Free Survival

    Progression-free survival is defined as the time from treatment onset to either disease progression or death from any cause, or discontinuation of treatment for any reason, whichever occurs first

    Measured: Up to 3 years

  4. Overall Survival

    Overall survival is defined as the time from treatment onset to death

    Measured: Up to 3 years

  5. Stable Disease for 9 Cycles

    Stable disease for 9 cycles is defined as proportion of patients whose stable disease last for at least 9 cycles.

    Measured: Nine cycles of therapy (Each cycle consists of a 21-day period)

  6. Adverse Events

    Adverse events were evaluated according to NCI CTCAT v5.0

    Measured: Up to 90 days after the last dose, approximately 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start23 Aug 2021
  3. Primary completion12 Aug 2025
  4. Study completion12 Aug 2025

Why it stopped: PI request, \<75% participation

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026736
Sponsor's protocol ID
2020-1212
Other IDs
NCI-2021-08962, 2020-1212
Status last verified
Jun 2026
First submitted
23 Aug 2021
Last updated
21 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quality-of-Life Assessment and Sintilimab in people with Locally Advanced Angiosarcoma and Metastatic Angiosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.

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 17 inclusion and 36 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: stopped early, as of the sponsor's last update on 21 Jul 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Rate at 9 Cycles (time frame: Nine cycles of therapy (Each cycle consists of a 21-day period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05026736.

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 21 Jul 2026.

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