Immune Checkpoint Inhibitors Plus Chemotherapy and Radiation/Chemoradiation Therapy Followed by Immune Checkpoint inhibitors Plus Chemotherapy for First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma with Dysphagia:A Pragmatic, Randomized, Phase II Trial

Immune Checkpoint Inhibitors Plus Chemotherapy and Radiation/Chemoradiation Therapy Followed by Immune Checkpoint inhibitors Plus Chemotherapy for First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma with Dysphagia:A Pragmatic, Randomized, Phase II Trial - Immune Checkpoint Inhibitors Plus Chemotherapy and Radiation/Chemoradiation Therapy Followed by Immune Checkpoint inhibitors Plus Chemotherapy for First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma with Dysphagia:A Pragmatic, Randomized, Phase II Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056051

Enrollment

Registered

2024-11-05

Start date

2024-12-02

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

FP plus ICI RT plus minus FP to FP plus ICI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically, the patient was diagnosed with squamous cell carcinoma of the esophagus (including the esophagogastric junction). 2.The patient has been diagnosed with stage IVB esophageal cancer (recurrent cases not included) that has distant metastasis and is not curatively resectable. 3.Patients with dysphagia score (DS 2-4). However, DS 4 cases are limited to those who are judged to be able to take oral medication by a method other than oral administration, such as a gastrostomy. 4.No prior chemotherapy or radiation therapy for esophageal cancer. 5.18 years of age or older at the time of obtaining informed consent. 6.ECOG performance status (PS) of 0 to 2. 7.Doctor in charge has determined that protocol treatment is safe 8.The contents of this study were fully explained to the participants, and written consent was obtained.

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to the components of 5-FU, cisplatin, nivolumab, or pembrolizumab. 2.No active overlapping cancers. However, early cancers such as superficial esophageal cancer and superficial head and neck cancer that are not considered to determine prognosis, and lesions equivalent to intraepithelial or intramucosal cancer that are considered to be cured by local treatment are acceptable. 3.pregnant or possibly pregnant 4.Doctor in charge has determined that the patient is inappropriate to participate in the study.

Design outcomes

Primary

Measure	Time frame
The rate of improvement in obstruction of the passage of blood (DS score of 1 or more) at 9 weeks after the start of protocol treatment	—

Secondary

Measure	Time frame
Rate of improvement in obstruction during protocol treatment period Period until passing obstruction is improved Dysphagia Progression-free survival Overall survival Progression-free survival Time to treatment failure Objective response rate Disease control rate Adverse events	—

Countries

Japan

Contacts

Public ContactYusuke Nagata

St. Marianna University School of Medicine Department of Clinical Oncology

yusuke.nagata@marianna-u.ac.jp0449778111

Outcome results

None listed

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