Clinical Study of Anlotinib Combined With Chemotherapy in the Treatment of Unresectable Advanced … (NCT05490667) | Clinical Trial Compass
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Clinical Study of Anlotinib Combined With Chemotherapy in the Treatment of Unresectable Advanced Desmoid Tumor
China30 participantsStarted 2022-08-20
Plain-language 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.
Who can participate
Age range10 Years – 72 Years
SexALL
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Inclusion Criteria:
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%;
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