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

NCT05490667 | Unknown

• 1 other identifier: HN-STS-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 advanced desmoid tumors.

Conditions

Desmoid

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  From initiation of treatment to tumor progression

  Up to approximately 24months

Study Arms (1)

Anlotinib

EXPERIMENTAL

Anlotinib combined with chemotherapy for desmoid tumors

Drug: Anlotinib

Interventions

Anlotinib DRUG

Anlotinib combined with chemotherapy for desmoid tumors

Also known as: chemotherapy

Anlotinib

Eligibility Criteria

• Age: 10 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.);
• 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;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Department of Bone and Soft Tissue ,Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Desmoid Tumors

Interventions

anlotinib; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

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: August 2, 2022
• First Posted: August 8, 2022
• Study Start: August 20, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)