A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer

A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer - A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016954

Enrollment

270

Registered

2015-04-01

Start date

2015-05-01

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

esophageal cancer

Interventions

S-588410 will be injected subcutaneously once weekly for 12 weeks and once every 2 weeks thereafter for 94 weeks. Placebo will be injected subcutaneously once weekly for 12 weeks and once every 2 week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with thoracic esophageal squamous cell carcinoma after neoadjuvant therapy followed by curative resection. 2. Patients with lymph node metastasis positive histologically 3. HLA-A*24:02-positive patients 4. Patients who are male or female aged 20 years or older at the time of informed consent. 5. Patients with the ECOG PS 0 or 1 at enrollment. 6. Patients who provide a personally signed and dated informed consent document for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who are expected to require anti-malignant tumor drug between enrollment and completion or discontinuation of the post-treatment period. 2. Patients with uncontrolled systemic or active infection.

Design outcomes

Primary

Measure	Time frame
Relapse free survival	—

Secondary

Measure	Time frame
Specific CTL measurement, overall survival, disease-free survival, tumor evaluation, quality of life, assessment of AEs (CTCAE)	—

Countries

Japan

Contacts

Public ContactYoshimasa Kyokawa

Shionogi & Co., Ltd. Corporate Communications Department

shionogiclintrials-admin@shionogi.co.jp06-6209-7885

Outcome results

None listed

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