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

Primary Purpose

Soft Tissue Sarcoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Piamprimab (AK105)
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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: 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Pathological complete response rate
From the beginning of treatment to the completion of surgery

Secondary Outcome Measures

Progression-free survival
From the start of treatment to the progression of the disease
Overall survival
From the beginning of treatment to death

Full Information

First Posted
January 30, 2023
Last Updated
August 21, 2023
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05718778
Brief Title
Piamprilizumab (AK105) Combined With Radiotherapy for Neoadjuvant Treatment of Soft Tissue Sarcoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Piamprilizumab (AK105) combined with radiotherapy for neoadjuvant treatment of soft tissue sarcoma
Arm Type
Experimental
Arm Description
Piamprilizumab (AK105) combined with radiotherapy for neoadjuvant treatment of soft tissue sarcoma
Intervention Type
Drug
Intervention Name(s)
Piamprimab (AK105)
Other Intervention Name(s)
radiotherapy
Intervention Description
Piamprilizumab (AK105) combined with radiotherapy for neoadjuvant treatment of soft tissue sarcoma
Primary Outcome Measure Information:
Title
Pathological complete response rate
Description
From the beginning of treatment to the completion of surgery
Time Frame
From the start of treatment to surgery at week 12
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
From the start of treatment to the progression of the disease
Time Frame
It takes about 12 weeks from the start of treatment to surgery
Title
Overall survival
Description
From the beginning of treatment to death
Time Frame
0 to 120 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, Dr
Phone
13733849759
Email
superwx1984@163.com
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, Dr
Phone
13733849759
Email
superwx1984@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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