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Soft Tissue SarcomaNCT05718778

Piamprilizumab (AK105) Combined With Radiotherapy for Neoadjuvant Treatment of Soft Tissue Sarcoma

A study testing Piamprimab (AK105) in people with Soft Tissue Sarcoma, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study was to evaluate the safety and efficacy of paamprilimab combined with radiotherapy for neoadjuvant treatment of soft tissue sarcoma. The primary endpoint was pathological complete response rate (CPR). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Piamprimab (AK105)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
20 Mar 2023to 31 Mar 2024
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age :18-70 years old, gender unlimited;
  • Histopathologically confirmed patients with stage I, II, and III resectable soft tissue sarcomas (subtypes These include undifferentiated pleomorphic sarcoma, angiosarcoma, fibrosarcoma, synovial sarcoma, and smooth muscle Sarcoma);
  • No previous treatment with radiotherapy, chemotherapy, antiangiogenic drugs or immune checkpoint inhibitors To cure;
  • Measurable lesions at baseline according to Recist version 1.1:
  • ECOGPS:0-2, expected survival greater than 6 months.
  • If the major organs are functioning normally, the following criteria are met:
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  • Hemoglobin (Hb)≥ 90g/L, neutrophil (ANC)≥1.5×109/L, Platelet count (PLT)≥ 80×109/L, Serum creatinine (Cr)≤ 1.5× upper limit of normal (ULN) or creatinine clearance (CCr)≥60ml/min; Total bilirubin (TB)≤ 1.5ULN; Aminotransferase (AST) and alanine aminotransferase (ALT)≤ 2.5×ULN; Left ventricular ejection fraction ≥50%;
  • Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For men, consent was required to use an appropriate method of contraception or to have been surgically sterilized during the trial period and within 8 weeks after the last administration of the trial drug
  • Sign an informed consent form (or legal representative sign) to demonstrate that they understand the purpose of the study and the procedures required by the Institute, and are willing to participate in the study.

Who cannot join

  • Previous chemoradiotherapy, use of antiangiogenic drugs or other immune checkpoint inhibitors;
  • Have any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy).
  • Patients with vitiligo or childhood asthma that has been completely resolved and can be admitted as adults without any intervention; Patients requiring medical intervention with bronchodilators are not included;
  • Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active B (HBVDNA≥500IU/mL), hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of analysis method) or co-infection of hepatitis B and hepatitis C;
  • Use of immunosuppressive drugs within 14 days prior to initial use of the study drug, excluding intranasal and inhaled corticosteroids or systemic steroid stimulants at physiological doses (i.e., not exceeding 10mg/ day prednisone or its equivalent);
  • Live attenuated vaccine administered within 4 weeks prior to initial administration or planned for the study period;
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  • Other malignant tumors in the past 3 years;
  • Imaging (CT or MRI) showed the presence of tumors invading local great vessels, or accompanied by the formation of tumor thrombus in great veins (iliac vessels, inferior vena cava, pulmonary veins, superior vena cava);
  • Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy;
  • Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal medical treatment); Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: male ≥450ms, female ≥470ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade ≥II cardiac insufficiency;
  • Severe cardiovascular disease, such as New York Heart Society Heart disease (Grade II or higher), myocardial infarction, cerebrovascular accident, unstable arrhythmia, unstable angina in the 3 months prior to enrollment, Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction <50%, must be treated with a stable treatment regimen as best determined by the treating physician, with consultation with a cardiologist if necessary;
  • A severe infection occurring within 4 weeks prior to initial administration (e.g., requiring intravenous antibiotic, antifungal, or antiviral medication), or an unexplained fever >38.5°C during screening/prior to initial administration;
  • A history of idiopathic pulmonary fibrosis, institutional pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening;
  • Had gastrointestinal or non-gastrointestinal fistula before enrollment (≥ grade 3);
  • Known history of allogeneic organ transplantation or allohematopoietic stem cell transplantation;
  • Pregnant or lactating women; Fertile patients are unwilling or unable to use effective contraception A doer;
  • Known allergic reaction, hypersensitivity or intolerance to test drugs and their excipients;
  • Subjects who are participating in another clinical study or whose first drug use is less than 4 weeks after the end of the previous clinical study (final drug use), or who have 5 half-lives of the investigational drug;
  • Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
  • Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.

Trial locations and contacts

1 site in 1 country.

Xin Wang, Dr contact

13733849759

superwx1984@163.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Xin Wang, Dr, 13733849759, superwx1984@163.com

    Recruiting

Other trials in China

About this study

Official title: Single-arm, Open, Exploratory Clinical Study on the Safety and Efficacy of Piamprilimab (AK105) Combined With Radiotherapy for Neoadjuvant Treatment of Soft Tissue Sarcoma

The primary objective of this study was to evaluate the safety and efficacy of paamprilimab combined with radiotherapy for neoadjuvant treatment of soft tissue sarcoma. The primary endpoint was pathological complete response rate (CPR).

Read the detailed description

31 patients with stage I, II, and III resectable soft tissue sarcoma were enrolled in this study at the Bone and soft Tissue Ward 1 of Henan Cancer Hospital. The main objective of this study was to evaluate the safety and efficacy of paamprimab combined with radiotherapy for neoadjuvant treatment of soft tissue sarcoma. The primary endpoint of this study was pathological complete response rate (CPR).

Being tested
Piamprimab (AK105)
Medical subject headings
Sarcoma

What participants receive

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

  • Piamprimab (AK105)Drug

    Also called radiotherapy

    Piamprilizumab (AK105) combined with radiotherapy for neoadjuvant treatment of soft tissue sarcoma

Study groups in NCT05718778
Study groupRoleWhat they receive
Piamprilizumab (AK105) combined with radiotherapy for neoadjuvant treatment of soft tissue sarcomaExperimentalPiamprilizumab (AK105) combined with radiotherapy for neoadjuvant treatment of soft tissue sarcoma
Receives: Drug: Piamprimab (AK105)

What is being measured

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

  1. Pathological complete response rate

    From the beginning of treatment to the completion of surgery

    Measured: From the start of treatment to surgery at week 12

Secondary outcomes (2)

  1. Progression-free survival

    From the start of treatment to the progression of the disease

    Measured: It takes about 12 weeks from the start of treatment to surgery

  2. Overall survival

    From the beginning of treatment to death

    Measured: 0 to 120 months

Timeline

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

  1. First posted8 Feb 2023
  2. Study start20 Mar 2023
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion31 Mar 2024 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05718778
Sponsor's protocol ID
RLXFZ-001
Status last verified
Jan 2024
First submitted
30 Jan 2023
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Piamprimab (AK105) in people with Soft Tissue Sarcoma, run by Henan Cancer Hospital 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 9 inclusion and 20 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 7 Feb 2024. 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.

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 Wang, Dr (13733849759, superwx1984@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: From the start of treatment to surgery at week 12). 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 NCT05718778.

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 7 Feb 2024.

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