Adriamycin and Ifosfamide Combined With Sintilimab

  • STATUS
    Recruiting
  • End date
    Jul 30, 2023
  • participants needed
    69
  • sponsor
    Sun Yat-sen University
Updated on 13 May 2022
metastasis
cancer chemotherapy
ifosfamide
angiosarcoma
adriamycin
fibrosarcoma
soft tissue sarcoma
liposarcoma
synovial sarcoma
undifferentiated pleomorphic sarcoma
leiomyosarcoma
epithelioid sarcoma
mpnst
malignant peripheral nerve sheath tumor

Summary

The aim of this study was to explore the efficacy and safety of adriamycin and ifosfamide combined with sintilimab in the treatment of advanced or unresectable soft tissue sarcoma.

Description

At present, there are a number of clinical trials of chemotherapy drugs combined with anti PD-1 antibody in the treatment of cancer, but the clinical research of chemotherapy containing adriamycin combined with anti-PD-1 antibody for advanced STS patients is almost blank. Regimen containing adriamycin is the standard chemotherapy regimen for advanced STS approved by international guidelines. As an innovative PD-1 monoclonal antibody, more phase II clinical studies are needed to evaluate the efficacy and safety of sintilimab in a variety of cancers. For patients who fail or cannot tolerate first-line treatment, treatment options are still limited. In view of the above problems, this study aims to observe and explore the efficacy and safety of chemotherapy including adriamycin combined with sintilimab in the second-line treatment of patients with advanced STS, so as to provide more and better treatment options for patients with advanced STS.

Details
Condition Soft Tissue Sarcoma
Treatment Sintilimab plus Chemotherapy
Clinical Study IdentifierNCT04589754
SponsorSun Yat-sen University
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients voluntarily participated in the study and signed informed consent
All advanced or non resectable soft tissue sarcomas confirmed by pathology
failed or did not have standard treatment or could not tolerate standard
treatment, Have at least one according to RECIST 1.1 the standard measurable
lesions mainly included synovial sarcoma, leiomyosarcoma, alveolar soft tissue
sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous
histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma
epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated
sarcoma, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma
Malignant solitary fibroma, sarcoma after radiotherapy. However, there are no
standard treatment types, such as alveolar soft tissue sarcoma, post
radiotherapy sarcoma, highly differentiated / dedifferentiated / pleomorphic
liposarcoma, clear cell sarcoma, etc.; except for the following types
chondrosarcoma, osteosarcoma, malignant mesothelioma, gastrointestinal stromal
tumor, etc
Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging
In the past three months, there was at least one measurable target lesion according to RECIST version 1.1 standard, and it can be accurately measured by magnetic resonance imaging (MRI) or computer tomography (CT) in at least one direction (the maximum diameter needs to be recorded), with conventional CT ≥ 20 mm or spiral CT ≥ 10 mm
They were 18-70 years old; ECoG PS score: 0-1; the expected survival time was more than 3 months
Within 7 days before treatment, the main organ functions met the following criteria
① Hemoglobin (HB) ≥ 90g / L
② The absolute value of neutrophil (ANC) ≥ 1.5 × 109 / L
Platelet (PLT) ≥ 80 × 109 / L
① Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN)
(1) Blood routine examination standard (without blood transfusion within 14
② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5uln
days)
such as
With liver metastasis, ALT and AST ≤ 5uln
③ Serum creatinine (CR) ≤ 1.5uln or creatinine clearance rate (CCR) ≥ 60ml
min
(2) Biochemical examination should meet the following standards
(3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower
limit of normal value (50%)
Women of childbearing age should agree that contraceptive measures (such as intrauterine
device, contraceptive or condom) must be used during the study period and within 6 months
after the end of the study; serum or urine pregnancy test negative within 7 days before
study enrollment, and must be non lactating patients; men should agree that contraceptive
measures must be used during the study period and within 6 months after the end of the
study period

Exclusion Criteria

) Patients who had previously received anti-PD-1 / PD-L1 antibody therapy
) Other malignancies occurred or were present within 5 years, except for cervical
carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non invasive
tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]
) The patients with thyroid dysfunction after the best drug treatment
) Systemic anti-tumor therapy including cytotoxic therapy, signal transduction inhibitors
immunotherapy (or mitomycin C within 6 weeks prior to the trial drug treatment) was planned
within 4 weeks before enrollment or during the study period. Over extended field
radiotherapy (ef-rt) was performed within 4 weeks before admission or limited field
radiotherapy (rfrt) was performed within 2 weeks before grouping
) With pleural effusion or ascites, it causes respiratory syndrome (≥ CTC AE grade 2
dyspnea [grade 2 dyspnea refers to shortness of breath with a small amount of activity; it
affects instrumental activities of daily living])
) Any unrelieved toxic reaction higher than CTC AE (4.01) grade 1 or above caused by
previous treatment, excluding alopecia
) Patients with any severe and / or uncontrolled disease, including
Chronic liver disease, decompensated liver disease or decompensated hepatitis
Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg)
Renal failure needs hemodialysis or peritoneal dialysis
Patients with myocardial ischemia or myocardial infarction of grade I or above
Poor control of diabetes mellitus (FBG > 10mmol / L)
arrhythmia (including QTc ≥ 480ms) and congestive heart failure (NYHA) grade ≥ 2
Active or uncontrolled severe infection (≥ CTC AE Level 2 infection)
Patients with epilepsy and need treatment
Urine routine examination showed that urine protein was ≥ + +, and 24-hour urine
protein was more than 1.0 G
) Major surgical treatment, open biopsy or obvious traumatic injury were performed within
days before admission
) Patients with any physical signs or history of bleeding regardless of severity; patients
with any bleeding or bleeding events ≥ CTCAE 3 within 4 weeks before enrollment had
unhealed wounds, ulcers or fractures
) Patients who had AVT events within 6 months, such as cerebrovascular accident
(including transient ischemic attack), deep vein thrombosis and pulmonary embolism
) There were active ulcer, intestinal perforation and intestinal obstruction
) Subjects with clinical symptoms of central nervous system metastasis (such as brain
edema, need for hormone intervention, or brain metastasis progression); patients who have
previously received treatment for brain or meningeal metastasis, such as clinical stability
(MRI) for at least 2 months, and who have stopped systemic hormone therapy (dose > 10mg
day, prednisone or other effective hormones) for more than 2 weeks can be included
) The subjects were using immunosuppressive agents, or systemic or absorbable local
hormone therapy to achieve the purpose of immunosuppression (dosage > 10mg / D, prednisone
or other effective hormones), and continued to use them within 2 weeks before enrollment
) Subjects with any active autoimmune disease or history of autoimmune diseases (e.g
but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis
vasculitis, nephritis, hyperthyroidism, hypothyroidism; if the subject has vitiligo or
asthma has been completely relieved in childhood, it is not necessary to be an adult Any
intervention can be included; asthma patients who need bronchodilator for medical
intervention cannot be included)
) The subjects had active tuberculosis
) According to the judgment of the researcher, the subjects are not suitable to be
enrolled or there are other factors that may lead to termination of the study, such as
other serious diseases (including mental diseases) requiring combined treatment, serious
laboratory examination abnormalities, and family or social factors, which will affect the
safety of the subjects, or the collection of test data and samples
) Patients who participated in other clinical trials of anti-tumor drugs within 28 days
before enrollment
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