Skip to content

Clinical application of Trastuzumab combined with chemotherapy in recurrent/advanced neuroendocrine carcinoma of the cervix with HER2 over-expression

Clinical application of Trastuzumab combined with chemotherapy in recurrent/advanced neuroendocrine carcinoma of the cervix with HER2 over-expression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075261
Enrollment
Unknown
Registered
2023-08-31
Start date
2023-08-31
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Neuroendocrine carcinoma of the cervix

Interventions

Trastuzumab Group (Treatment Group):Trastuzumab was administered in a 3-week regimen with an initial loading dose of 8mg/kg, followed by 6mg/kg administered every 3 weeks, and repeated 6mg/kg administ
The first infusion time is about 90 minutes. If the patient has good tolerance during the first infusion, the subsequent infusion can be changed to 30 minutes.

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Female, age = 18 years old; 2) NECC treated at Peking Union Medical College Hospital has undergone standard treatment (chemotherapy regimen based on small cell lung cancer, etoposide+cisplatin/carboplatin), but the condition still relapses/progresses; 3) There is HER2 over-expression; 4) The patient's Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2; 5) Karnofsky score = 70 points;

Exclusion criteria

Exclusion criteria: 1) The patient is generally unable to tolerate chemotherapy and oral medication treatment; 2) Patients who are known to be allergic to trastuzumab drugs; 3) Immunohistochemical testing of tumor samples suggests no overexpression of HER2 or mutations in RAS and BRAF genes; 4) Patients with severe acute infections; 5) Patients with other serious or uncontrollable diseases; 6) Patients with case records who have participated in any clinical study of other investigational drugs or medical devices within 30 days prior to medication, except for observational studies; 7) Researchers believe that there are any other factors that are not suitable for inclusion or that affect participation or completion of the study.

Design outcomes

Primary

MeasureTime frame
Progression free survival;Overall survival;

Secondary

MeasureTime frame
Adverse reaction;Changes in the size of solid tumor lesions;

Countries

China

Contacts

Public ContactXiao-chen Song

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

song_xc@163.com+86 152 1093 1146

Outcome results

None listed

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