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A prospective, multi-center, single-arm clinical study for the efficacy and safety of dasatinib in the treatment of patients with unsuccessful imatinib desmoid tumor therapy.

A prospective, multi-center, single-arm clinical study for the efficacy and safety of dasatinib in the treatment of patients with unsuccessful imatinib desmoid tumor therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800020096
Enrollment
Unknown
Registered
2018-12-14
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desmoid Tumor

Interventions

Case series:pharmacotherapy 50mg/2 times/d

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed desmoid tumor and unsuccessful imatinib desmoid tumor therapy history. 2. Existing measurable focus according to RECIST1.1 3. Male and Female,age=10 years old,<70 years old. 4. ECOG performance score 0-2. 5. Conform to the following criteria for inoperable cases after radiographic evaluation: (1) the radical resection will cause massive defect of soft tissue and result in loss of limb function and huge change of appearance; (2) the radical resection will implicate the main nerves and vessels; (3) the tumor is invasive to the bone; (4) the patients refuse surgery; (5) amputation is not considered. 6. Informed patient or the legal guardian of underaged patient, and signed informed consent; 7. Good patients compliance, voluntary acceptance of follow-up, treatment, laboratory examination and other research steps.

Exclusion criteria

Exclusion criteria: 1. AST and/or ALT>2.5×ULN, or TSB>1.5×ULNCr>1.5×ULN; 2. The absolute value of ANC<1.5×10^9/L, or blood platelet <75×10^9/L, or Hb<90g/L; 3. Diagnosed with malignant tumor within 5 years, except adequately treated skin basal cell carcinoma or carcinoma in situ of cervix; 4. Diagonsed with any of the following diseases within 12 months of enrollment: myocardial infarction severe/unstable anginacoronary arterial/peripheral arterial bypass grafting, symptomatic congestive heart failure or cerebrovascular accident; 5. Serum HIV antibody positive; 6. Currently enrolled in other clinical trial; 7. Pregnant or fertile women without contraceptive measures; 8. Diagnosed with other severe acute or chronic dysfunction or mental health problems, abnormal laboratory examination results, would increase the risk of joining research or using medication, interfering the result of research, unfit for enrollment after researchers judgment.

Design outcomes

Primary

MeasureTime frame
progression free survival (PFS);

Secondary

MeasureTime frame
Complete Remission (CR);Partial Remission (PR);progression of disease (PD);stable disease (SD);tumor control probability (CR+PR+SD);

Countries

China

Contacts

Public ContactLi shu

Peking University Cancer Hospital

lishu_doctor@163.com+86 13810095311

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026