CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study-

CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study- - CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study-

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006975

Enrollment

Registered

2011-12-28

Start date

2011-12-01

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

previously treated HER2 positive advanced gastric cancer

Interventions

CPT-11 / Trastuzumab(CPT-11 150 mg/kg q2w and Trastuzumab 8 or 6 mg/kg q3w) or PTX / Trastuzumab(PTX 80 mg/kg qw 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) Positive HER2 status(IHC3+ or IHC2+/FISH+) (3) Written informed conscent 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 evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline. (8) Adequate organ function as follows: 1. WBC count 3,500-12,000/mm3 2. Neutrophils count more than 1,500/mm3 3. Platelet count more than 100,000/mm3 4. Hemoglobin more than 8.0 g/dl 5. Serum bilirubin level less than 1.5 mg/dl 6. Ast and ALT less than 100 IU/l 7. Serum creatinine level less than 1.2 mg/dl 8. Creatinine clearance more than 50mL/min 9. LVEF more than 50% (9)More than one previous chemotherapy(except adjuvant chemotherapy). (10)No previous CPT-11 history.

Exclusion criteria

Exclusion criteria: (1) Forbidden case to use CPT-11/PTX and Trastuzumab. (2) Baseline left ventricular ejection fraction (LVEF) is <50% measured by echocardiography or MUGA scan. (3) In the UGT1A1 allele, UGT1A1(*)6/(*)6 genotype or UGT1A1(*)28/(*)28 genotype UGT1A1(*)28/(*)6 genotype (4) R1 operation(histlogically positive PM, OM, LM, VM). (5) Infection or inflammatory case. (6) Severe heart disease. (7) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc. (8) Severe ascites and/or pleural effusion. (9) Multiple bone metastasis. (10) Clinical suspicion or previous history of metastasis to brain or meninges. (11) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage. (12)Complicated other active cancer. (13)patient who want to be pregnant and /or pregnant woman. (14)Intend to make pregnant. (15)Active hepatitis type HBs positive. (16)No previous treatment(except adjuvant chemotherapy). (17)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.

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 Safety	—

Countries

Japan

Contacts

Public ContactMasahiko Miura

Matsue City Hospital Gastroenterology

m.miura@matsue-cityhospital.jp0852-60-8000

Outcome results

None listed

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