Japan/Korea Joint Phase II Study of Nimotuzumab plus Irinotecan in Patients with Advanced or Recurrent Gastric Cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220818

Enrollment

Registered

2009-08-18

Start date

2009-08-18

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

Advanced or Recurrent Gastric Cancer Refractory to 5-fluorouracil-containing Regimens

Interventions

investigational material(s) Generic name etc : DE-766 (nimotuzumab) INN of investigational material : nimotuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed gastric adenocarcinoma. Unresectable or recurrent gastric cancer patients, refractory to 5-fluorouracil-based agents or 5-fluorouracil-containing therapy. Only "one prior regimen" is eligible. ECOG Performance Status is 0-1

Exclusion criteria

Exclusion criteria: Patients who previously received irinotecan Patients who previously received EGFR-directed therapy (e.g. cetuximab, erlotinib). Patients with any of the following severe or uncontrolled intercurrent diseases

Design outcomes

Primary

Measure	Time frame
Progression Free Survival RECIST (ver. 1.0)	—

Secondary

Measure	Time frame
Response rate, disease control rate, duration of response, time to progression, time to treatment failure, overall survival, safety, pharmacokinetics RECIST (ver. 1.0), NCI-CTC (ver. 3.0)	—

Outcome results

None listed

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