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Immunotherapy drug sintilimab takes on rare blood vessel cancer

NCT ID NCT05026736

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether sintilimab, an immunotherapy drug, can help control angiosarcoma—a rare cancer of the blood vessels—that is advanced, has spread, or has returned. Participants receive sintilimab intravenously, and the study measures how many have no cancer growth after nine treatment cycles. The trial enrolls adults who have already tried chemotherapy without success or cannot tolerate it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an immunotherapy drug called sintilimab, which helps the immune system attack cancer cells
What this could lead to
If successful, this could offer a new treatment option for people with angiosarcoma who have not responded to chemotherapy.
What could go wrong
This is a small, early-phase trial with only 6 participants, so results may not apply broadly. The drug may cause immune-related side effects or fail to control the cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.