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Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.

Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer. - Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015431
Enrollment
45
Registered
2014-11-01
Start date
2014-11-01
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

unrecectable or recurrent advanced gastric cancer

Interventions

Patients receive 180mg of nab-paclitaxel per square meter of body-surface area on day 1 of every 21-day cycle. The patients continue therapy until disease progression or prohibitive toxic effects occu

Sponsors

Yokohama City University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Unresectable or recurrent advanced gastric cancer 2.Histologically confirmed adenocarcinoma, signet ring cell caricinoma and mucinous adenocarinoma. 3.Prior treatment by chemothrapy including 5-FU regimen 4.No central nurve metastasis 5.Age from 20 to 65 years old 6.Performance status is 0,1,2. 7.Required baseline laboratory data.(within 14 days of registration) Neu 1,500mm3 PLT 100,000mm3 T-Bil 1.5mgdL AST 100IU/L ALT 100IU/L serum creatine 1.5mg/dL 8.Expected survival time more than 90 days 9.The patient has previously given written, informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1.With history of receiving paclitaxel treatment 2.With serious drug allergy 3.With servaral comorbid disease poorly controlled diabetes poorly controlled hypertension liver cirrhosis, liver failure renal failure intestitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema active infectious disease heart failure, myocardial infarction, angina pectoris or ECG abnormalities within 6 months 4.With active anothor cancer 5.With peripheral neuropathy greater than grade2 6.With HBs antigen positive 7.With pregnant or nursing women 8.Cases who physician judged improper to entry this trial

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Overall survival(OS),Progression free survival(PFS),Safty, Time to progression(TTP)

Countries

Japan

Contacts

Public ContactRyo Takagawa

Yokohama City University Medical Center Gastroenerological Center

rtakagawa@gmail.com045-261-5656

Outcome results

None listed

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