Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

ConditionBone Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChina Medical University Hospital

About this trial

This is an investigator-initiated, single-center clinical trial evaluating the efficacy and safety of ALK inhibitors in patients with locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations. Eligible patients must have disease progression after standard therapy or no suitable standard treatment options.

Participants will receive either crizotinib (Xalkori®) or alectinib (Alecensa®), with treatment selection determined by the study investigators. The study aims to assess antitumor activity, safety, and clinical outcomes in this rare molecular subtype of bone cancer.

Eligibility criteria

Qualifiers

Age ≥ 20 years.

Patients with locally advanced or metastatic solid tumors harboring deficiency or alteration of anaplastic lymphoma kinase (ALK) tyrosine kinase.

Disease progression during or within 6 months after completion of standard therapy, or no appropriate standard treatment available.

At least one measurable lesion according to applicable response evaluation criteria.

Disqualifiers

Known hypersensitivity to crizotinib or alectinib.

Current or prior use of ALK inhibitors.

Current use of tyrosine kinase inhibitors.

Receipt of radiotherapy within 2 weeks prior to study entry. Palliative radiotherapy to non-target lesions is permitted.

Trial design

Treatments tested in this trial

  • Alectinib

Treatment groups

10 Participants
are divided into 1 treatment group