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A Single-Arm, Prospective, Exploratory Study of the Efficacy and Safety of Anrotinib in the Treatment of Solid Tumour-Associated Pulmonary Tumourous Thrombotic Microangiopathy (PTTM)

A Single-Arm, Prospective, Exploratory Study of the Efficacy and Safety of Anrotinib in the Treatment of Solid Tumour-Associated Pulmonary Tumourous Thrombotic Microangiopathy (PTTM)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105990
Enrollment
Unknown
Registered
2025-07-15
Start date
2025-07-20
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Pulmonary neoplastic thrombotic microangiopathy (PTTM)

Interventions

PTTM group:Anrotinib 12mg QD treatment

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age =18 years; 2. Histologically or cytologically confirmed solid malignant tumor; 3. ECOG performance status score of 0–4; 4. No prior treatment with VEGF/VEGFR inhibitors (including but not limited to sunitinib, bevacizumab, anlotinib, apatinib, or endostar); 5. Meeting the clinical diagnostic criteria for pulmonary tumor thrombotic microangiopathy (PTTM).

Exclusion criteria

Exclusion criteria: 1. Receipt of any investigational drug therapy or participation in an interventional clinical trial within 28 days prior to the first dose; 2. Known history of hypersensitivity to anlotinib (including its active/inactive excipients) or other drugs with similar structures or pharmacological classes; 3. Concurrent severe infections, including but not limited to drug-resistant bacterial infections, bloodstream infections, opportunistic infections, or refractory infections as assessed by the investigator; 4. Presence of septic shock.

Design outcomes

Primary

MeasureTime frame
Oxygenation index improved by 50% from baseline after 1 week of anrotinib treatment;50% improvement in D-dimer kinetics after 1 week of treatment with amlotinib;Tricuspid Transvalvular Pressure Reduced by 30% from Baseline After 1 Week of Anrotinib Treatment;

Secondary

MeasureTime frame
PFS;OS;DOR;Adverse event rate;Serious adverse event rate;Incidence of adverse events or serious adverse events leading to treatment discontinuation;

Countries

China

Contacts

Public ContactCheng Chen

The First Affiliated Hospital of Soochow University

chencheng@suda.edu.cn+86 137 7177 5292

Outcome results

None listed

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