General drug use-results surveillance of Phesgo for combination subcutaneous injection MA and IN - Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy -

General drug use-results surveillance of Phesgo for combination subcutaneous injection MA and IN - Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy - - Phesgo general drug use-results surveillance (Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052965

Enrollment

100

Registered

2023-12-01

Start date

2023-12-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects to be registered: Patients with unresectable advanced or recurrent HER2-positive colorectal cancer who are scheduled to use this drug for the first time during the registration period or have progressed after cancer chemotherapy for the first time using this drug at sites that have concluded the contract for this investigation

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main items 1)Site information: Name of site, name of department, date of CRF entry, name of physician who entered the CRF 2)Patient characteristics: Patient's initials, gender, pregnancy, identification number within a site, age at the start of treatment, reason for use (HER2 overexpression/gene amplification test), height, weight, performance status (ECOG PS), treatment line, site of cancer, primary lesion, site of metastasis, complication, medical history, switching from pertuzumab/trastuzumab combination therapy to this drug 3)History of prior treatment: Drug therapy, surgery/radiotherapy 4)Administration status: Dose of this drug per administration, date of administration, premedication, status at entry of CRF 5)Concomitant therapy: radiotherapy 6)Adverse events: Name of adverse event or abnormal test value, date of onset, worst grade, seriousness, treatment, outcome, date of outcome, causal relationship (this drug, others)	—

Measure

Time frame

Main items 1)Site information: Name of site, name of department, date of CRF entry, name of physician who entered the CRF 2)Patient characteristics: Patient's initials, gender, pregnancy, identification number within a site, age at the start of treatment, reason for use (HER2 overexpression/gene amplification test), height, weight, performance status (ECOG PS), treatment line, site of cancer, primary lesion, site of metastasis, complication, medical history, switching from pertuzumab/trastuzumab combination therapy to this drug 3)History of prior treatment: Drug therapy, surgery/radiotherapy 4)Administration status: Dose of this drug per administration, date of administration, premedication, status at entry of CRF 5)Concomitant therapy: radiotherapy 6)Adverse events: Name of adverse event or abnormal test value, date of onset, worst grade, seriousness, treatment, outcome, date of outcome, causal relationship (this drug, others)

—

Countries

Japan

Contacts

Public ContactShinichi Matsuda

Chugai Pharmaceutical Co. Ltd. Safety Science Dept.

matsudasni@chugai-pharm.co.jp03-3281-6611

Outcome results