Real-world Study of HER2-overexpressed Advanced Solid Tumors After Progression of First-line Standard Therapy

Launched by SHEN LIN · Dec 5, 2022

Keywords

ClinConnect Summary

This is a prospective, non-interventional, multi-cohort, multi-center real-world study to evaluate the treatment pattern and clinical outcomes of patients with advanced HER2-overexpressed solid tumors after the progression of first-line standard therapy. Enrolled subjects in this study were treated according to the treatment protocol established by physicians according to clinical routine. The tests, examinations and drug use in the study were consistent with the requirements of the clinical practice. No additional tests, examinations and drugs were generated from the data collection in thi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signing informed consent and agreeing to comply with study requirements;
• • Age ≥18 years old, gender unlimited;
• • ECOG physical status 0-2 points;
• • Patients with locally advanced or metastatic solid tumors confirmed histologically or cytologically;Cohort1-2 cohort: patients who had received at least previous first-line standard therapy (HER2 IHC3+ or IHC2+/FISH+ patients with first-line trastuzumab (or its biosimilar) combined with chemotherapy (fluorouracil and/or platinum-based chemotherapy);IHC2+/FISH- patients with first-line Immunotherapy combined with chemotherapy (fluorouracil and/or platinum-based chemotherapy) or chemotherapy alone);In Cohort3 cohort, patients received at least the standard first-line treatment clearly recommended by the guidelines. Patients with clear disease progression confirmed by the investigator or documented history.
• • HER2 overexpression was defined as 2+ or 3+ immunohistochemistry (both primary and metastatic tumor tissue were acceptable), and previous patient test results (confirmed by the investigator) or center test results were acceptable.
• • Have measurable or evaluable lesions according to RECIST1.1 criteria;
• • The investigator evaluated that the patients would benefit from the study treatment;
• • Good compliance, willing and able to follow the trial and follow-up procedures;
• • Have traceable patient medical records.
• Exclusion Criteria:
• • Known hypersensitivity or delayed allergic reactions to certain components of the study drug or similar drugs;
• • Participating in any interventional clinical trials;
• • The investigator assessed inappropriate inclusion.

Trial Officials