Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Advanced STS

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

The study is expected to include 24 patients with metastatic or surgically unresectable relapsed/refractory soft tissue sarcoma confirmed by histological evidence, who have received at least one line of systemic treatment previously. The efficacy and safety of liposome irinotecan combined with temozolomide and bevacizumab in the treatment of relapsed/refractory soft tissue sarcoma will be evaluated.

Eligibility criteria

Qualifiers

Age ≥14 years old, gender not limited;

For metastatic or surgically unresectable recurrent and refractory soft tissue sarcomas confirmed by histological evidence, this combination therapy regimen can be used as determined by the researcher.

Disease progression or intolerable toxicity has occurred after at least one line of systemic therapy (with or without targeted therapy) in the past.

At least one measurable lesion (RECIST v1.1);

Disqualifiers

Patients with known central nervous system metastases;

Severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation above grade 2; diarrhea above grade 1);

Patients who have a history of treatment with irinotecan, temozolomide, bevacizumab or similar drugs;

Within the two weeks prior to randomization, there was third space effusion (such as a large amount of pleural effusion) that could not reach a stable state except for ascites (no intervention treatment is required after the drainage tube is removed);

Trial design

Treatments tested in this trial

  • Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma

Treatment groups

24 Participants
are divided into 1 treatment group