Observational study of serum HER2 in HER2 positive advanced gastric cancer treated with trastuzumab in combination with capecitabine plus cisplatin(XP+H)

Observational study of serum HER2 in HER2 positive advanced gastric cancer treated with trastuzumab in combination with capecitabine plus cisplatin(XP+H) - SHERLOCK2 Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006445

Enrollment

Registered

2011-09-29

Start date

2011-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease 2) 20 years old or over 3) HER2 positive tumor (IHC or FISH) 4) Eligible for XP+H by the investigator's decision 5) Signed informed consent

Exclusion criteria

Exclusion criteria: 1)Other malignancies within the last 2 years, except for carcinoma in situ or basal cell carcinoma 2)Positive serum pregnancy test in women of childbearing, or lactating women 3)History of psychiatric disability judged by investigator to be clinically significant, precluding informed consent. 4)Serious intercurrent infections 5)Patients whom physician determines as inappropriate

Design outcomes

Primary

Measure	Time frame
Changes of serum HER2	—

Secondary

Measure	Time frame
Progression Free Survival Safety Overall response rate Overall survival Receive rate of the 2nd line treatment Complete rate of 2 cycle of XP+H Relationship between serum HER2 and tissue HER2	—

Countries

Japan

Contacts

Public ContactMayuko Saito

Sapporo Medical University 1st department of Internal Medicine

m.saitou@sapmed.ac.jp011-611-2111

Outcome results