Phase 1 clinical study on the combination therapy of CHP-NY-ESO-1 cancer vaccine and Poly-ICLC for the treatment of patients with NY-ESO-1 expressing refractory esophageal cancer

Phase 1 clinical study on the combination therapy of CHP-NY-ESO-1 cancer vaccine and Poly-ICLC for the treatment of patients with NY-ESO-1 expressing refractory esophageal cancer - Phase 1 clinical study on the combination therapy of CHP-NY-ESO-1 cancer vaccine and Poly-ICLC for the treatment of patients with refractory esophageal cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007961

Enrollment

Registered

2012-05-15

Start date

2012-02-01

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

Refractory esophageal cancer

Interventions

First cohort CHP-NY-ESO-1 200 micrograms Poly-ICLC 0.5mg SQ injection, q2wks, 6 cycles Second cohort CHP-NY-ESO-1 200 micrograms Poly-ICLC 1.0mg SQ injection, q2wks, 6 cycles Third cohort CHP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Standard therapy-resistant esophageal cancer with clinical stage IV or recurrent, metastatic disease. 2. Histologically confirmed esophageal cancer 3. NY-ESO-1-antigen expression of tumor confirmed by immunohistochemistry or RT-PCR 4. Life expectancy: >= 3 months from the date of consent 5. Age: >= 20 years 6. Performance status (ECOG scale): 0-2 7. Adequate organ functions, measured as follows: White blood cells: >=2,000/mm3 Hemoglobin: >= 8.0g/dL Thrombocyte: >= 7.5*104/mm3 Total birilbin: <= 1.5*ULN AST (GOT): <=3*ULN ALT (GPT): <=3*ULN Serum creatinine: <=1.5*ULN 8. Time from prior therapy: >= 2 weeks after the last administration date of prior chemotherapy >= 2 weeks after the lastradiation date of prior radiotherapy >= 4 weeks afer the date of last syrgery >= 4 weeks after thelast treatment date of prior immunotherapy 9. Having written informed consent

Exclusion criteria

Exclusion criteria: 1. Past history of severe hypersensitivity 2. Positive for HIV antibody 3. Experience of autoimmune disease requiring treatment during 6 months preceding the day of consent 4. Use of steroids (more than 20 mg equivalent of prednisolone/day) or immunosuppressive drugs 5. Patients with following severe complications # severe heart disease or uncontrolled angina # Uncontrolled diabetes mellitus # Intestinal paresis or ileus # Active infections requiring antibiotics # Other severe complications 6. Pregnant or lactating women 7. Inappropriate for study entry judged by an attending physicians

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD), dose limiting toxicity (DLT) and adverse effects.	—

Secondary

Measure	Time frame
Immune response	—

Countries

Japan

Contacts

Public ContactTakeshi Ishikawa

Kyoto Prefectural University of Medicine Gastroenterology

iskw-t@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

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