AzTrials
AzTrials

DesmoidNCT05490667

Clinical Study of Anlotinib Combined With Chemotherapy in the Treatment of Unresectable Advanced Desmoid Tumor

A study testing Anlotinib in people with Desmoid, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Thirty patients with desmoid tumors (invasive fibromatosis) will be recruited in the Department of Bone and Soft Tissue, Henan Cancer Hospital. This is a prospective, multicenter, single-arm clinical study to evaluate the efficacy and safety of anlotinib combined with chemotherapy in the treatment of inoperable… Read more about this study

Who is it for?
Ages 10 to 72 years
Conditions the study is for
Desmoid
What is being tested?
Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
20 Aug 2022to 31 Jul 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 10 to 72 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Advanced desmoid tumor confirmed by pathology.
  • The presence of measurable lesions meeting RECIST 1.1 criteria.
  • Male and female, aged ≥10 years.
  • Eastern Cooperative Oncology Group(ECOG) physical condition 0-2 points.
  • Radiographic evidence of recurrence or disease progression within the past 6 months (according to RECIST criteria).
  • Imaging evaluation met the inoperable criteria as follows:
Show all 15Show fewer
  • Radical surgery will cause large defects of skin, muscle and other soft tissues, resulting in great changes in limb appearance and loss of function, or require major reconstructive surgery such as patch repair and flap repair; Radical surgery will involve the main blood vessels and nerves; The tumor involves the bone, and the safe margin cannot be achieved under the premise of bone preservation; By explaining the condition to the patient, the patient refuses to try the operation after weighing the advantages and disadvantages; Amputation is not considered.
  • Major organ function is normal, that is, meet the following criteria: 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) ≤ ULN;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; Albumin (ALB) ≥ 35g/L
  • Prothrombin time (PT) and partial prothrombin time (PTT) ≤1.2×ULN left ventricular ejection fraction ≥50%;
  • Patients gave informed consent and signed a written consent form.
  • Patients had good compliance and voluntarily accepted follow-up, treatment, laboratory tests, and other research steps as planned.

Who cannot join

  • Patients who have used anlotinib, pesopanib, sorafenib, sunitinib, apatinib and other TKI drugs in the past;
  • with pleural effusion or ascites, causing respiratory syndrome (≥CTCAE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath with little activity; affects instrumental activities of daily living]);
  • The presence or current presence of other malignant tumors within 3 or 5 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane));
  • Systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, was planned within 4 weeks before enrollment or during the study medication period (or silk was used within 6 weeks before treatment with the trial drug) Schizomycin C). Overextended field radiotherapy (EF-RT) was performed within 4 weeks before grouping or field-limited radiotherapy to evaluate tumor lesions was performed within 2 weeks before enrollment.
  • Unrelieved toxic reactions above CTCAE(4.0) grade 1 due to any previous treatment, excluding alopecia;
  • with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
Show all 31Show fewer
  • Patients with any severe and/or uncontrolled disease, including:
  • Patients with poor blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg);
  • Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTC ≥480ms), or congestive heart failure grade 2 (New York Heart Association (NYHA) classification);
  • Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
  • Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral therapy;
  • Renal failure requiring hemodialysis or peritoneal dialysis;
  • Have a history of immunodeficiency, including being HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
  • poor diabetes control (fasting blood glucose (FBG) > 10mmol/L);
  • The urine routine indicated urinary protein ≥++, and confirmed 24-hour urinary protein quantity > 1.0 g;
  • patients with epileptic seizures requiring treatment;
  • Patients with hypothyroidism: Thyroid stimulating hormone（TSH）>4.2mlU/L;
  • Subjects with any medical condition that may increase the risk of gastrointestinal bleeding or perforation: such as active gastrointestinal ulcers, known luminal metastatic lesions, inflammatory bowel disease, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the study;
  • Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.);
  • Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days before enrollment;
  • Patients whose imaging showed that the tumor had invaded the periphery of important blood vessels or who were judged by the investigator to be very likely to invade important blood vessels during the subsequent study and cause fatal massive bleeding;
  • Patients with any evidence of bleeding constitution or history, regardless of severity; Four weeks before grouping In patients with any bleeding or bleeding events ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures; Significant blood coughing or daily hemoptysis of 2.5ml or more within 2 months before enrollment;
  • Experienced an arteriovenous thrombotic event within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
  • Abnormal coagulation (INR > 1.5 or PT >1.2 ULN or PTT >1.2 ULN), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  • Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or similar agents;
  • Those who had received a potent CYP3A4 inhibitor within 7 days or received a potent CYP3A4 inducer within 12 days prior to study enrollment. Drugs with CYP3A4, CYP2D6, or CYP2C8 substrates should be avoided;
  • Use drugs that may lead to prolongation of QT interval and tip torsion in ECG within 4 weeks;
  • Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders;
  • Participated in clinical trials of other antitumor drugs within four weeks;
  • Pregnant or lactating patients;
  • Any condition that, in the investigator's judgment, may impair the subject's ability to meet or perform the study requirements.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Department of Bone and Soft Tissue ,Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Peng Zhang, 13526693125, heartnesszp@126.com

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Anlotinib Combined With Chemotherapy in the Treatment of Unresectable Advanced Desmoid Tumors: a Prospective Single-arm Clinical Study

Thirty patients with desmoid tumors (invasive fibromatosis) will be recruited in the Department of Bone and Soft Tissue, Henan Cancer Hospital. This is a prospective, multicenter, single-arm clinical study to evaluate the efficacy and safety of anlotinib combined with chemotherapy in the treatment of inoperable advanced desmoid tumors.

Read the detailed description

Thirty patients with desmoid tumor (invasive fibromatosis) will be recruited in the Department of Bone and Soft Tissue, Henan Cancer Hospital. This is a prospective, multicenter, single-arm clinical study to evaluate the efficacy and safety of anlotinib combined with chemotherapy in the treatment of inoperative advanced desmoid tumor. To evaluate the 6-month progression-free survival rate, 12-month progression-free survival rate, progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) and safety of anlotinib combined with chemotherapy for desmoid tumors.

Conditions
Desmoid
Being tested
Anlotinib
Medical subject headings
Desmoid Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnlotinibDrug

    Also called chemotherapy

    Anlotinib combined with chemotherapy for desmoid tumors

Study groups in NCT05490667
Study groupRoleWhat they receive
AnlotinibExperimentalAnlotinib combined with chemotherapy for desmoid tumors
Receives: Drug: Anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    From initiation of treatment to tumor progression

    Measured: Up to approximately 24months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start20 Aug 2022
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05490667
Sponsor's protocol ID
HN-STS-002
Status last verified
Aug 2023
First submitted
2 Aug 2022
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Anlotinib in people with Desmoid, 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 15 inclusion and 31 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 30 Oct 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Up to approximately 24months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05490667.

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 30 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in