A Phase 2 Study of Sirolimus for Injection (Albumin-bound) in Patients With Progressive or Symptomatic Epithelioid Hemangioendothelioma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

A Single-Arm, Non-Randomized, Open-Label Phase 2 Study of Nab-Sirolimus in Patients with Progressive or Symptomatic Epithelioid Hemangioendothelioma.

Detailed Description: Avoid duplicating information that will be entered or uploaded elsewhere in the record.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN).

Disqualifiers

Nitrosoureas (e.g., carmustine, lomustine) or mitomycin C: within 6 weeks prior to the first dose of study drug;

Oral fluoropyrimidines and small-molecule targeted agents: within 2 weeks prior to the first dose of study drug or within 5 known half-lives of the drug, whichever is longer;

Traditional Chinese medicines with anti-tumor indications: within 2 weeks prior to the first dose of study drug.

Received any other unapproved investigational product within 4 weeks prior to the first dose of study drug.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sirolimus for injection (Albumin-bound)

    Drug

    Sirolimus for injection (Albumin-bound) will be administered intravenously on day 1and day 8 every 21 days (a cycle).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

The percentage of patients who achieved a confirmed overall response of PR or CR assessed by RECIST V1.1.

Time frame
2 years

Secondary outcomes

1

Disease Control Rate (DCR)

The percentage of patients with confirmed complete response (CR), partial response (PR), or stable disease (SD) lasting ≥ 4 weeks from baseline

Time frame
2 years
2

Duration of Response (DOR)

The time from the start of CR or PR to the first date of documented PD or death

Time frame
2years
3

Progression-free Survival (PFS)

The time from the first dose to the first documented disease progression or death from any cause, which occurs first.

Time frame
2years
4

Overall survival (OS)

The time from the first dose to death from any cause.

Time frame
2years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: