Sintilimab for Locally Advanced Angiosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Locally Advanced Angiosarcoma+3 More
Sintilimab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether sintilimab can help treat patients with angiosarcoma.

See full description

Eligible Conditions

  • Locally Advanced Angiosarcoma
  • Recurrent Angiosarcoma
  • Metastatic Angiosarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Sintilimab will improve 1 primary outcome and 6 secondary outcomes in patients with Locally Advanced Angiosarcoma. Measurement will happen over the course of Up to 90 days after completion of treatment.

Day 21
Progression-free rate
Year 5
Duration of response
Year 5
Overall survival
Year 5
Progression free survival
Up to 5 years
Objective response rate (complete response + partial response)
Stable disease rate
Day 90
Incidence of adverse events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (sintilimab)
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Sintilimab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (sintilimab)Patients 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sintilimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Locally Advanced Angiosarcoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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)

Patient Q&A Section

What are the signs of hemangiosarcoma?

"Hemangiosarcomas are common soft-tissue tumors among adults. Most cases occur in the extremities. In a recent study, we found that hemangiosarcomas were associated with many systemic symptoms. These included gastrointestinal bleeding, weight loss, weakness, fatigue and malaise. All patients with hemangiosarcoma should be evaluated for systemic symptoms. If they are diagnosed with systemic symptoms, then further tests (such as CT scans, MRIs and PET scans) should be performed to identify the tumors. If there is any suspicion of hemangiosarcoma, then biopsy should be considered for definitive diagnosis." - Anonymous Online Contributor

Unverified Answer

Has sintilimab proven to be more effective than a placebo?

"Data from a recent study support the use of sintilimab as an active drug in combination with conventional chemotherapy in the treatment of patients with metastatic soft tissue sarcoma." - Anonymous Online Contributor

Unverified Answer

How does sintilimab work?

"Sintilimab suppresses the immune system's T cell response against tumors in preclinical and clinical studies. The current results show that CD8+ T cells express functional complement receptors CCR2 and CCR5. Complement activation via these receptors facilitates apoptosis of tumor cells during antibody-dependent cellular cytotoxicity. Inhibition of CD8+ T cell function and antigen presentation may account for the antitumor activity of sintilimab." - Anonymous Online Contributor

Unverified Answer

Does sintilimab improve quality of life for those with hemangiosarcoma?

"In patients with HSA, who received sintilimab, there was an overall improvement in QoL as measured by EORTC QLQ C30 and EORTC QLQ VAS. It is important to note that these improvements were sustained during the majority of follow-up." - Anonymous Online Contributor

Unverified Answer

How serious can hemangiosarcoma be?

"Hemangiosarcomas are rare neoplasms; they occur more often in boys younger than 10 years old. A study of over 4000 children between 1995 and 2009 showed an incidence rate of 2.2 per 100000 every year. In 2012, hemangiosarcoma was the second most common cancer in childhood, after acute lymphoblastic leukemia. Most cases occur in the anterior extremities, including the head, neck, trunk, arms, and legs. The most common site is the lower extremity, especially the thigh, followed by the scapula, gluteal region, and abdomen. The average age at diagnosis is 8 years, and males are diagnosed slightly earlier than females." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in sintilimab for therapeutic use?

"Sintilimab has shown activity in patients with metastatic hemangiosarcoma. However, further determination of its optimal timing and sequence will be required before this agent can be routinely used in sarcoma clinical practice." - Anonymous Online Contributor

Unverified Answer

Is sintilimab safe for people?

"The data presented support our conclusion that sintilimab is safe and effective as monotherapy for patients with relapsed HSA who are refractory to conventional therapy. It is also safe and effective when used with chemotherapy. Data from a recent study also suggest that it should be evaluated in combination with other antitumor agents for patients with HSA who are not eligible for brentuximab vedotin. Notably, as part of our study, we had no incidence of serious infusion-related reactions with sintilimab." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hemangiosarcoma?

"The majority of patients prefer enrollment in a clinical trial rather than standard care. Patients who are considering enrollment in a clinical trial should consider the risks and benefits of the trial. They should also discuss any questions they may have about the trial with their physician and family member. Patients should ask about the possibility of participation in a clinical trial at every visit." - Anonymous Online Contributor

Unverified Answer

How many people get hemangiosarcoma a year in the United States?

"For persons aged <40 years, the annual incidence rate of HSA was 2.9 cases per 100000 persons. In contrast, for persons ≥ 40 years, the incidence rate was 1.1 cases per 100000 persons per year (P<0.0001). These incidence rates were similar for white and black populations. Men had a higher incidence rate than women (25.5 vs. 19.1 cases per 100000 persons per year; P=0.0017). Median age at diagnosis was 61 years (range, 27-84 years). Of the 35 patients who died from HSA, 4 were under age 50 years. Overall, there were 12 deaths among the 455 patients with malignant disease because of HSA." - Anonymous Online Contributor

Unverified Answer

What does sintilimab usually treat?

"Patients who responded to sintilimab were treated for different diseases than those who did not respond. Therefore, we suggest that clinicians consider other possible causes when treating SIRS and TTP." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for hemangiosarcoma?

"The 10-year survival rate was 45%. Over the last decade, the prognosis has improved for patients with hemangiosarcoma treated with surgery followed by adjuvant chemotherapy. However, there remains a need for more effective and well-studied therapies to improve this dismal outcome." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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