A PhaseII study of XP(capecitabine plus cisplatin) combination therapy for HER2 negative advanced/recurrent gastric cancer

A PhaseII study of XP(capecitabine plus cisplatin) combination therapy for HER2 negative advanced/recurrent gastric cancer - SGCSG G-04

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013669

Enrollment

Registered

2014-04-08

Start date

2014-04-08

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

HER2 negative advanced/recurrent gastric cancer

Interventions

CDDP80mg/m2, Day1 Capecitabine2000mg/m2, Day1-15 Tri-weekly, until PD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma(included EGJ cancer). (2)Negatibe HER2 status if tested. (3)Written informed consent to receive this chemotherapy. (4)20 years old or more than 20 years old. (5)Eastern Cooperative Oncology Group(ECOG) performance status 0-2. (6)Life expectancy of at least 3 months after registration. (7)Case which has lesions to be measureable and non-measureable according to RECIST(Response Evaluation Criteria in Solid Tumors) guideline. (8)Adequate organ function as follows: 1.Nuetrophils count more than 1,500/mm3 2.Platelet count more than 100,000/m3 3.Serum bilirubin level than 1,5mg/dl 4.AST and ALT less than 100IU/l 5.Serum creatinine level less than 1.2mg/dl 6.Cretinine clearance more than 50mL/min (9)Without previous chemotherapy(except adjuvant chemotherapy).

Exclusion criteria

Exclusion criteria: (1)Forbidden case to use capecitabine and cisplatin. (2)R1 operation(histologically positive PM, OM, LM, VM). (3)Infection or inflammatory case. (4)Severe heart disease. (5)Severe complicated case such as ileus, intestitial pneumonia, uncontrolled DM, liver cirrhosis etc. (6)Difficulty to join the trial due to psychosis nervous system damage. (7)Complicated other active cancer. (8)patient who want to be pregnant and/or pregnant woman. (9)Intend to make pregnant. (10)Active hepatitis type HB positive(HBs antigen, HBc antibody and HBs antibody). (11)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study).

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Time to response, Disease control rate, Progression free survival, Time to treatment failure, Overall survival, Relative dose intensity, safety	—

Countries

Japan

Contacts

Public ContactNoriyuki Hirahara

Shimane university faculty of medicine Department of digestive and general surgery

norinori@med.shimane-u.ac.jp0853-20-2232

Outcome results

None listed

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