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A Phase I Study of DE-766 with Concurrent Chemoradiotherapy in Patients with Locally Advanced Esophageal Cancer

A Phase I Study of DE-766 with Concurrent Chemoradiotherapy in Patients with Locally Advanced Esophageal Cancer

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221282
Enrollment
20
Registered
2010-10-25
Start date
2010-10-25
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

Esophageal cancer

Interventions

Sponsors

DAIICHISANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with stage II, III (non-T4), or IV (non-T4 and M1 lymph nodes) esophageal cancer, who considered suitable to undergo definitive radiotherapy Patients without a history of esophageal cancer treatment and without a history of previous treatment of other malignant tumors

Exclusion criteria

Exclusion criteria: Patients with another active malignancy Patients with severe esophageal stenosis or esophago-mediastinal fistula Patients with any of the severe or uncontrolled complications

Design outcomes

Primary

MeasureTime frame
Dose limiting toxicity and maximum tolerated dose CTCAE(Ver.4.0)

Secondary

MeasureTime frame
Adverse events, pharmacokinetic, anti-tumor effects, complete response rate, progression-free survival, overall survival rate CTCAE(Ver.4.0), RECIST(Ver.1.1)

Outcome results

None listed

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