Phase II clinical trial of surgical intervention following chemotherapy for synchronous and metachronous liver metastasis from gastric cancer.

Phase II clinical trial of surgical intervention following chemotherapy for synchronous and metachronous liver metastasis from gastric cancer. - Phase II clinical trial of surgical intervention for liver metastasis from gastric cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011445

Enrollment

Registered

2013-08-10

Start date

2011-11-14

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

Patients with synchronous or metachronous liver metastasis from gastric cancer

Interventions

(A) Neo-adjuvant chemotherapy (2-4 kur): Attending physician selects one of the 3 regimen below. (1)SP: S-1 (80mg/m2/day, d1-21)+ Cisplatin (60mg/m2, d8) / 5W, (2)DCS: S-1 (80mg/m2/day, d1-14) + C

8 mg/kg, second and subsequent

6mg/kg) /3W. (B) Surgical intervention: (1)Primary lesion

total gastrectomy, distal gastrectomy, and proxymal gastrectomy, with more than D2 lymph node dissection. (2)Metastatic lesion

Partial hepatectomy is the basic treatment, but segment resection or lobectomy will considered if necessary. Moreover, RFA or MCT will be permitted only when curtive treatment can be expected.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with synchronous or metachronous liver metastasis from gastric cancer. 2) Number of liver metastatic lesion is no more than 4. 3) Maximal diameter of liver metastatic lesion is no more than 5 cm. 4) Performance status is 0-2. 5) There is no evidence of peritoneal dissemination and no metastatic lesion other than liver.

Exclusion criteria

Exclusion criteria: 1) Patients with difficulty in oral intake. 2) Patients with contraindication for administration of S-1, Cisplatin, Docetaxel, Capecitabine, Trastuzumab, and 5 FU. 3)Patients with other kinds of active cancers overlapping gastric cancer. 4) Patients with evidence of peritoneal dissemination or metastatic lesion other than liver (eg. bone, brain). 5) Patients with a history of bone metastasis.

Design outcomes

Secondary

Measure	Time frame
Rate of complete resction (surgical resection), and rate of curative treatment (include intervention of RFA or MCT) for hepatic lesion. Safety of procedure (rate of intra/post operative adverse events), recurrence-free survival time of curative treatment case, and overall survival time of registered patients.	—

Primary

Measure	Time frame
Three years overall survival rate of patient who achieved curative treatment.	—

Countries

Japan

Contacts

Public ContactShinno Naoki

Osaka University Graduate School of Medicine, Osaka, Japan Department of Gastroenterological Surgery

nshinno@gesurg.med.osaka-u.ac.jp+81668793251

Outcome results

None listed

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