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Sintilimab for Angiosarcoma
Study Summary
This trial is testing sintilimab as a treatment for angiosarcoma. Sintilimab is an immunotherapy that may help the body's immune system attack the cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 397 Patients • NCT03607539Trial Design
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- I am using effective birth control and will continue for 6 months after the trial ends.If unsure about my eligibility, I will contact the sponsor with my full medical history.You have at least one detectable tumor that can be measured according to specific guidelines.I've had a bad reaction or my cancer got worse after chemotherapy.The amount of protein in your urine needs to be low.I can provide tissue samples for additional tests.I have been treated with specific drugs that target the immune system.I have been on IV nutrition for less than 4 weeks due to severe malnutrition.I've had a bad reaction or my cancer got worse after chemotherapy.My cancer has spread to my bones, risking paralysis.I have a known history of primary immunodeficiency.I have active tuberculosis in my lungs.I have had cancer before, but it's either been treated, is under control, or is a type that doesn't need treatment now.I haven't had a heart attack, stroke, or similar event in the last 6 months.I have stable brain metastases and haven't needed steroids for 2 weeks.I do not have any serious infections that need treatment.I have not had major surgery in the last 4 weeks and am not scheduled for any during the trial.I haven't taken any cancer or immune system treatments in the last 2 weeks.My high blood pressure is not controlled even with treatment.I haven't had any serious GI issues like perforation or abnormal connections within the last 6 months, except for procedures like gastrostomy.I am taking corticosteroids for my lung condition.My kidney function is within the required range.I have not received a live vaccine in the last 4 weeks and won't during the study.You are expected to live for at least 12 more weeks.You are expected to live for at least 12 weeks.I don't have an active autoimmune disease needing treatment, except for certain conditions like vitiligo or controlled hypothyroidism.I have had an organ or stem cell transplant from another person.I have severe liver issues like cirrhosis or hepatic encephalopathy.I have heart failure symptoms or uncontrolled heart rhythm problems.You have HIV (positive for anti-HIV antibody).I am currently pregnant or breastfeeding.I haven't had serious blood clots in the last 3 months.I do not have a current bowel blockage or a history of major bowel diseases or surgeries.My liver function tests are within the required limits.I have active hepatitis B or C with specific viral load levels.My angiosarcoma cannot be removed by surgery and has spread.I can provide tissue samples for additional tests.You have at least one specific spot that can be measured according to certain guidelines.I am fully active and can carry on all pre-disease activities without restriction.My blood clotting ability is within the normal range, even if I'm on blood thinners.I haven't taken strong immune system drugs in the last 2 weeks, except for low-dose steroids or allergy prevention.I do not have any health conditions that could affect the trial's safety or results.All my side effects from previous cancer treatments, except for hair loss and minor issues, have mostly gone away.I am 18 years old or older.My angiosarcoma cannot be removed by surgery and has spread.I am fully active and can carry on all pre-disease activities without restriction.I am 18 years old or older.I had radiation for symptom relief on a specific area within the last 2 weeks.I am not in another treatment study for angiosarcoma, but may be in an observational study or follow-up phase.Your platelet count is at least 75 billion per liter.I can provide tissue samples for additional tests.Your white blood cell count is at least 1.0 x 10^9/L.Your hemoglobin level is at least 8.0 grams per deciliter.Your total bilirubin level should be less than 1.5 times the upper limit of normal.I do not have any uncontrolled health conditions that could increase my medical risks.
- Group 1: Treatment (sintilimab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What safety measures are in place for individuals receiving Sintilimab treatments?
"Although there is limited evidence of Sintilimab's efficacy, the safety data available has enabled our team to assign it a score of 2 according to Power."
Is enrollment still open for this research experiment?
"Affirmative. According to the clinicaltrials.gov listing, this trial is currently recruiting individuals who meet its criteria; it was initially posted on August 23rd 2021 and updated most recently in July of 2022. 30 enrollees are sought from one medical centre."
How many participants is this trial recruiting?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial, first published on August 23rd 2021 is actively seeking participants. Approximately 30 individuals must be recruited from one medical centre."
Does this therapeutic trial bring something new to medicine?
"Since Innovent Biologics (Suzhou) Co. Ltd.'s 2017 Phase 3 trial for Sintilimab, which included 290 research participants, the drug has seen active studies conducted in 86 cities and 10 countries - 136 of them being ongoing as of today. Of these experiments, 132 have already been completed to date."
Could you enumerate the previous experiments conducted involving Sintilimab?
"Presently, over a hundred clinical studies are underway for Sintilimab with 15 of those in the last stages of their research. Most trials take place in Beijing; however, there exists 228 trial locations across the world."
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