Multicenter prospective observational study of immune checkpoint inhibitor based therapy in advanced esophageal cancer patients with dysphagia

Multicenter prospective observational study of immune checkpoint inhibitor based therapy in advanced esophageal cancer patients with dysphagia - Multicenter prospective observational study of immune checkpoint inhibitor based therapy in advanced esophageal cancer patients with dysphagia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053183

Enrollment

Registered

2023-12-21

Start date

2023-12-20

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced esophageal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ) Histologically diagnosed with esophageal squamous cell carcinoma or adenosquamous carcinoma 2) Unresectable esophageal with primary tumor 3) Dysphagia with score of 1 or higher. *Passability of upper gastrointestinal endoscopy is not a criterion 4) Age 20 or older 5) ECOG Performance Status (PS) of 0-2 6) Receives first-line treatment with checkpoint inhibitor combined chemotherapy (nivolumab + 5-FU + cisplatin, pembrolizumab + 5-FU + cisplatin), or nivolumab + ipilimumab therapy, with an expected treatment duration of at least 8 weeks 7) Written consent obtained

Exclusion criteria

Exclusion criteria: 1) Expected prognosis of less than 3 months 2) History of receiving checkpoint inhibitor therapy 3) History of radiation therapy to the primary esophageal cancer, or planned concurrent chemoradiation therapy 4) Presence of uncontrollable comorbidities or serious complications 5) Presence of a mental disorder that makes it difficult to complete questionnaires 6) Considered unsuitable for enrollment in this study by the attending physician

Design outcomes

Primary

Measure	Time frame
The proportion of patients who have an improvement of dysphagia score and who can accommodate passage of an endoscope (endoscope with a diameter of 8.9-10.4 mm) at 8 weeks from the start of treatment.	—

Secondary

Measure	Time frame
1) Proportion of sustained efficacy at the primary site at 24 weeks 2) Proportion of primary tumor reduction equivalent to T1 within 24 weeks 3) Overall survival (OS) and the relationship between efficacy of primary tumor and OS 4) Overall response rate (ORR) and the relationship between efficacy of primary tumor and ORR 5) Progression-free survival (PFS) 6) Duration of sustained improvement in dysphagia score (Dysphagia PFS) 7) Proportion of patients weaned off supplemental nutrition 8) Proportion of patients receiving additional treatment for the primary tumor 9) Safety	—

Measure

Time frame

1) Proportion of sustained efficacy at the primary site at 24 weeks 2) Proportion of primary tumor reduction equivalent to T1 within 24 weeks 3) Overall survival (OS) and the relationship between efficacy of primary tumor and OS 4) Overall response rate (ORR) and the relationship between efficacy of primary tumor and ORR 5) Progression-free survival (PFS) 6) Duration of sustained improvement in dysphagia score (Dysphagia PFS) 7) Proportion of patients weaned off supplemental nutrition 8) Proportion of patients receiving additional treatment for the primary tumor 9) Safety

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Countries

Japan

Contacts

Public ContactYurika Nakayama

Toyama University Hospital Third department of internal medicine

yurika.pp0522@gmail.com+81-76-434-7301

Outcome results