Trial Title:
Anrotinib Hydrochloride Combined With Adriamycin for Neoadjuvant Treatment of High-grade Soft Tissue Sarcoma
NCT ID:
NCT05747521
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Doxorubicin
Liposomal doxorubicin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Anrotinib hydrochloride combined with adriamycin
Description:
To evaluate the efficacy of anrotinib hydrochloride combined with doxorubicin in the
neoadjuvant treatment of high-grade soft tissue sarcoma
Arm group label:
Anrotinib hydrochloride combined with adriamycin
Summary:
This is an investigator-initiated, single-arm, single-center, prospective clinical study
with an estimated 58 patients enrolled to explore the efficacy and safety of anrotinib
hydrochloride in combination with doxorubicin and radiotherapy in patients with
high-grade soft tissue sarcoma.
Detailed description:
This is a single-arm, single-center, prospective investigator-initiated clinical study of
58 patients enrolled in Henan Cancer Hospital to explore the efficacy and safety of
anrotinib hydrochloride combined with doxorubicin and radiotherapy in patients with
high-grade soft tissue sarcoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18-65 years old, regardless of gender.
2. Patients with soft tissue sarcomas of trunk or limbs of G3 confirmed by histology or
cytology; Pathological types include synovial sarcoma, undifferentiated pleomorphic
sarcoma, leiomyosarcoma and fibrosarcoma.
3. No treatment with anthracyclines or anti-angiogenic targeted drugs.
4. According to RECIST Version 1.1 (Annex 1), there were measurable lesions at baseline
with primary tumors larger than 5cm and poor location in deep fascia;
5. ECOG Physical status score (Annex 2) a is 0-2, and the expected survival period is
more than 6 months.
6. Recovery from previous treatment: According to NCI-CTCAE version 5.0, all side
effects (except hair loss) resolved to grade 1 or below.
7. If the major organs are functioning normally, the following criteria are met:
Hemoglobin (Hb) ≥ 95g/L, Neutrophil (ANC) ≥1.5×109/L, Platelet count (PLT) ≥
80×109/L, Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN), blood urea
nitrogen (BUN) ≤ 2.5× upper limit of normal (ULN); Total bilirubin (TB) ≤ 1.5ULN;
Aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; Albumin (ALB) ≥
35 g/L Prothrombin time (PT) and partial prothrombin time (PTT) ≤1.2×ULN Left
ventricular ejection fraction ≥50% Blood pressure was controlled within 140/90 mmHg
before enrollment
8. 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
is 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
9. 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:
1. Previous exposure to antirotinib hydrochloride or other small molecule
anti-angiogenic TKI drugs, or anti-angiogenic mab drugs (such as Sunitinib,
Sorafenib, bevacizumab, imatinib, Famitinib, Apatinib, Regafenib, etc.).
2. Systemic antitumor therapy, including cytotoxic therapy, signal transduction
inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to treatment with the
experimental drug) was planned for 4 weeks prior to enrollment or during the
medication period of this study. Over extended field radiotherapy (EF-RT) was
performed within 4 weeks prior to enrollment.
3. Other malignant neoplasms (other than squamous cell carcinoma of skin) in the past 3
years;
4. Imaging (CT or MRI) showed that the tumor lesions had tumors invading local great
vessels, or were accompanied by tumor thrombus formation of large veins (iliac
vessels, inferior vena cava, pulmonary veins, superior vena cava);
5. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis
require antiviral therapy;
6. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood
pressure ≥90 mmHg, despite optimal medical treatment);
7. Urine routine indicated urine protein ≥ ++, or confirmed 24 hours urine protein
volume ≥1.0 g, urine protein/creatinine ≥1;
8. Uncontrolled co-morbidity, including, but not limited to, poorly controlled
diabetes, persistent active infections, or mental illness or social conditions that
may affect study compliance;
9. Abnormal coagulation function (INR > 1.5 or PT >1.2 ULN or PTT >1.2 ULN), bleeding
tendency or receiving thrombolytic or anticoagulant therapy; Patients treated with
anticoagulants or vitamin K antagonists such as warfarin, heparin, or their
equivalents;
10. Obvious blood coughing or daily hemoptysis of 2.5ml or above within 2 months before
enrollment;
11. Subjects with any medical conditions that may increase the risk of gastrointestinal
bleeding or gastrointestinal perforation, such as active gastrointestinal ulcers,
known luminal metastases, inflammatory bowel disease, and a history of abdominal
fistula, gastrointestinal perforation, or abdominal abscess within 28 days prior to
study initiation;
12. Factors that significantly affect oral drug absorption, such as inability to
swallow, chronic diarrhea and intestinal obstruction, including but not limited to a
history of stomach or small intestine resection, and malabsorption syndrome;
13. Subjects who have had any of the following cardiovascular diseases in the past six
months: Stroke (CVA) or transient cerebral ischemia (TIA), arrhythmia (including QTc
interval ≥450 ms for men and 470 ms for women), angina, coronary angiogenesis or
heart stents, pulmonary embolism, Patients with untreated or anticoagulant therapy
for less than 6 weeks with deep vein thrombosis, arterial thrombosis, Grade III or
IV heart failure as defined by the New York Heart Association's functional grading
system, and clinically significant pericardial disease in patients with left
ventricular ejection fraction (LVEF) < 50% indicated by cardiac color ultrasound, Or
electrocardiogram suggests acute ischemia or abnormal conduction system;
14. Patients with active viral hepatitis B or hepatitis C, or active infections
requiring antimicrobial treatment (e.g. antibiotics, antiviral drugs, antifungal
drugs); 15.4 weeks of participation in other antitumor clinical trials
(non-immunotherapeutic;
16. Hypothyroidism patients: TSH>4.2mlU/L; 17.7 days of treatment with a potent CYP3A4
inhibitor, or 12 days prior to study entry. Drugs with substrates for CYP3A4,
CYP2D6, or CYP2C8 should be avoided; 18.4 weeks use of drugs that may lead to
prolonged QT interval and tip torsion; 19. Open wounds, sores or fractures; 20.4
weeks of surgery; 21. Serous effusion (including pleural effusion, ascites,
pericardial effusion) with clinical symptoms that require surgical treatment; 22.
Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs,
coagulation disorders, thrombocytopenia, hyperplenism, etc.); 23. Lactation period;
24. Hiv-positive patients; 25. Those who have a history of psychotropic substance
abuse and cannot abstain or have mental disorders; 26. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Weitao Yao, Dr
Phone:
15838008899
Email:
ywtwhm@163.com
Start date:
April 29, 2021
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747521
