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Efficacy and Safety of Trastuzumab Deruxtecan in Advanced Solid Tumors with HER-2 Alterations or Low Expression: A Multicenter, Observational, Real-World Study

Efficacy and Safety of Trastuzumab Deruxtecan in Advanced Solid Tumors with HER-2 Alterations or Low Expression: A Multicenter, Observational, Real-World Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114397
Enrollment
Unknown
Registered
2025-12-11
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Solid Tumors

Interventions

Advanced Non-Small Cell Lung Cancer (First-Line, Second-Line, =Third-Line Therapy):None
Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (First-Line, Second-Line, =Third-Line Therapy):None
Advanced Colorectal Cancer (First-Line, Second-Line, =Third-Line Therapy):None
Other HER-2 Altered or Low-Expression Advanced Solid Tumors:None

Sponsors

The First Affiliated Hospital of Jinzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Signing of informed consent and voluntary participation in the study. 2. Histologically or cytologically confirmed advanced solid tumor. 3. Age>=18 years. 4. Documented HER-2 alteration, including HER-2 mutation, HER-2 amplification, HER-2 positivity (IHC 3+ or IHC 2+/ISH+), or HER-2 low expression (IHC 2+/ISH- or IHC 1+). 5. The investigator considers the patient suitable for treatment with Trastuzumab Deruxtecan (SHR-1811) as monotherapy or in combination therapy.

Exclusion criteria

Exclusion criteria: 1. Patients who are concurrently receiving other therapeutic agents of the same class. 2. Patients currently participating in other interventional studies. 3. Patients who are pregnant or lactating (confirmed by testing). 4. Any other condition where, in the opinion of the investigator, the patient is not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of Adverse Events >= Grade 3;

Secondary

MeasureTime frame
Objective response rate;Progression Free Survival, PFS;Overall survival;Intracranial Objective Response Rate, iORR;Intracranial Progression Free Survival, iPFS;

Countries

China

Contacts

Public ContactXiaomei Liu

The First Affiliated Hospital of Jinzhou Medical University

liuxm@jzmu.edu.cn+86 416 419 7429

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026