A Phase II study of capecitabine plus cisplatin (plus trastuzumab) for previously untreated advanced gastric cancer.

A Phase II study of capecitabine plus cisplatin (plus trastuzumab) for previously untreated advanced gastric cancer. - XP+trastuzumab for advanced gastric cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005998

Enrollment

Registered

2011-08-01

Start date

2011-08-01

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

untreated advanced gastric cancer

Interventions

A group(HER2 negative):XP(CDDP 80mg/m2 d1 and Capecitabine 2000 mg/m2 d1-15 q3w) B group(HER2 positive):XP+HER(CDDP 80mg/m2 d1 and Capecitabine 2000 mg/m2 d1-15 and Trastuzumab 8 or 6 mg/kg q3w)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma (included EGJ cancer) (2) Written informed conscent to recieve this chemotherapy (3) More than 20 years old (4) Eastern Cooperative Oncology Groupe (ECOG) performance status of 0-2 (5) Life expectancy mor than 12 weeks (6) Presence of a measureable lesion for evaluation according to RECIST 1.1 (7) Adequate organ function as follows: 1. WBC count 4,000-12,000/mm3 2. Platelet count more than 100,000/mm3 3. Hemoglobin more than 8.0 g/dl 4. Serum bilirubin level less than 1.5 mg/dl 5.Ast and ALT less than 100IU/l 6. Alp within twice the normal upper limits 7. Serum creatinin level less than 1.5mf/dl (8) The patients can take food oraly (9) Without previous medication history such as radiation therapy, chemotherapy and immunotherapy (except adjuvant chenmotherapy) (10) Electrocardiogram was performed within 28 days

Exclusion criteria

Exclusion criteria: (1) Forbidden case to use capecitabine and/or cisplatin (2) Infection or inflammatory case (3) Severe heart disease (4) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc (5) a lot of ascites (6) many bone metastasis (7) brain metastasis (8) repeated gastrointestinal bleeding (9) severe psychological disease (10) complicated other active cancer (11) pregnant or intended to be pregnant (12) intend to make pregnant (13) others

Design outcomes

Primary

Measure	Time frame
PFS: Progression Free Survival	—

Secondary

Measure	Time frame
ORR: Overall Response Rate DCR: Disease Control Rate OS: Overall Survival The safty and efficacy of the biomarker; TP/DPD, HR, ER, PgR status	—

Countries

Japan

Contacts

Public ContactHideo Matsumoto

Kawasaki Medical University Digestive surgery

h-matsu@med.kawasaki-m.ac.jp086-462-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026