Soft Tissue SarcomaNCT05747521
Anrotinib Hydrochloride Combined With Adriamycin for Neoadjuvant Treatment of High-grade Soft Tissue Sarcoma
A study testing Anrotinib hydrochloride combined with adriamycin in people with Soft Tissue Sarcoma, run by Henan Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Anrotinib hydrochloride combined with adriamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2021to 30 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old, regardless of gender.
- 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.
- No treatment with anthracyclines or anti-angiogenic targeted drugs.
- 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;
- ECOG Physical status score (Annex 2) a is 0-2, and the expected survival period is more than 6 months.
- Recovery from previous treatment: According to NCI-CTCAE version 5.0, all side effects (except hair loss) resolved to grade 1 or below.
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- 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
- 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
- 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 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.).
- 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.
- Other malignant neoplasms (other than squamous cell carcinoma of skin) in the past 3 years;
- 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);
- 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);
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- Urine routine indicated urine protein ≥ ++, or confirmed 24 hours urine protein volume ≥1.0 g, urine protein/creatinine ≥1;
- 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;
- 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;
- Obvious blood coughing or daily hemoptysis of 2.5ml or above within 2 months before enrollment;
- 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;
- 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;
- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Weitao Yao, Dr, 15838008899, ywtwhm@163.com
About this study
Official title: A Single Arm, Single Center, Prospective Clinical Study of Anrotinib Hydrochloride Combined With Doxorubicin in the Neoadjuvant Treatment of High-grade Soft Tissue Sarcoma
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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Anrotinib hydrochloride combined with adriamycin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anrotinib hydrochloride combined with adriamycinDrug
To evaluate the efficacy of anrotinib hydrochloride combined with doxorubicin in the neoadjuvant treatment of high-grade soft tissue sarcoma
| Study group | Role | What they receive |
|---|---|---|
| Anrotinib hydrochloride combined with adriamycin | Experimental | Anrotinib hydrochloride combined with adriamycin neoadjuvant therapy for patients with high-grade soft tissue sarcoma Receives: Drug: Anrotinib hydrochloride combined with adriamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit.
Measured: It is expected to take up to 60 months from treatment to disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start29 Apr 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, YaoWeitao, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747521
- Sponsor's protocol ID
- HN-STS-001
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Single Center, Prospective Clinical Study of Anrotinib Hydrochloride Combined With Doxorubicin in the Neoadjuvant Treatment of High-grade Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT05747521
- Acronym / sponsor ID
- HN-STS-001
- Conditions
- Soft Tissue Sarcoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anrotinib hydrochloride combined with adriamycin | Experimental | Drug: Anrotinib hydrochloride combined with adriamycinAnrotinib hydrochloride combined with adriamycin neoadjuvant therapy for patients with high-grade soft tissue sarcoma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18-65 years old, regardless of gender.
- 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.
- No treatment with anthracyclines or anti-angiogenic targeted drugs.
- 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;
- ECOG Physical status score (Annex 2) a is 0-2, and the expected survival period is more than 6 months.
Key exclusion criteria (15 listed)
- 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.).
- 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.
- Other malignant neoplasms (other than squamous cell carcinoma of skin) in the past 3 years;
- 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);
- Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anrotinib hydrochloride combined with adriamycinTo evaluate the efficacy of anrotinib hydrochloride combined with doxorubicin in the neoadjuvant treatment of high-grade soft tissue sarcoma | Drug | Anrotinib hydrochloride combined with adriamycin |
Primary outcome
Objective response rate
Time frame: It is expected to take up to 60 months from treatment to disease progression
Proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anrotinib hydrochloride combined with adriamycin 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 10 inclusion and 15 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 28 Feb 2023. 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 Weitao Yao, Dr (15838008899, ywtwhm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: It is expected to take up to 60 months from treatment to disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2023.