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

NCT05718778 | Unknown DMC

• 1 other identifier: RLXFZ-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  From the beginning of treatment to the completion of surgery

  From the start of treatment to surgery at week 12

Secondary Outcomes (2)

• Progression-free survival

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

• Overall survival

  0 to 120 months

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Piamprimab (AK105)

Interventions

Piamprimab (AK105) DRUG

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

Also known as: radiotherapy

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xin Wang, Dr

CONTACT

13733849759; superwx1984@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: March 20, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)