NIPH Clinical Trials Search

A randomized controlled phase II trial of induction treatment for Japanese patients with cT4 esophageal cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	thoracic esophageal cancer
Date of first enrollment	09/02/2026
Target sample size	102
Countries of recruitment
Study type	Interventional
Intervention(s)	1. Chemoradiotherapy Administer 5-FU 1000 mg/m2 on days 1-4 and cisplatin 75 mg/m2 on day 1 as one 4-week course, repeated twice. Radiation therapy begins on day 1 of the first chemotherapy course (1.8 Gy per fraction, once daily, 5 days per week, total 28 fractions). 2. Immune Checkpoint Inhibitor-Combined Chemotherapy Nivolumab 360mg/body on day 1, docetaxel 70mg/m2 on day 1, 5-FU 750mg/m2 on days 1-5, and cisplatin 70mg/m2 on day 1. One course consists of these treatments administered every 3 weeks. Up to 3 courses are administered until the tumor becomes resectable.

Outcome(s)

Primary Outcome	Overall survival
Secondary Outcome	(1) R0 resection rate (2) 2-year overall survival rate (3) progression-free survival (4) response rate to induction therapy (5) complete histological response rate (6) incidence of adverse events from induction therapy (7) incidence of perioperative complications (8) incidence of immune-related adverse events (irAEs)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 80age old
Gender	Both
Include criteria	1) Primary cases of thoracic esophageal cancer diagnosed histologically as squamous cell carcinoma (including adenocarcinoma with squamous differentiation and basaloid carcinoma), including cases partially involving the cervical or abdominal esophagus. 2) Unresectable thoracic esophageal cancer clinically demonstrating adjacent organ invasion (cT4) without distant organ metastasis. Positive abdominal lymph nodes (No. 1, 2, 3, 7, 9) and supraclavicular lymph nodes (No. 10-4) are eligible, but cases meeting the following conditions are excluded: -Primary lesion in upper thoracic region (Ut): Positive abdominal lymph node metastasis -Primary lesion in the middle thoracic region (Mt): Positive metastasis in both supraclavicular and abdominal lymph nodes -Primary lesion in the lower thoracic region (Lt): Positive metastasis in both supraclavicular and abdominal lymph nodes 3) Patient aged at registration is 18 years or older and less than 80 years. 4) Patient with ECOG Performance status (PS) 0 or 1. 5) Patient without prior drug therapy (endocrine therapy, chemotherapy, molecular targeted therapy, immunotherapy) within the past 5 years, including treatment for other cancer types. 6) Patient without prior radiation therapy to the neck or chest, including treatment for other cancer types. 7) Patient without prior treatment for esophageal cancer. However, endoscopic resection achieving curative resection (pT1a, ly0, v0) is acceptable. 8) The most recent laboratory values obtained within 14 days prior to registration (values from the same day of the week 2 weeks prior to the registration date are acceptable) meet all of the following criteria: (1) White blood cell count >= 3000/mm3 and < 12000/mm3 (2) Neutrophil count >= 1500/mm3 (3) Hemoglobin >= 8.0 g/dL (No blood transfusion within 14 days prior to the blood draw date for the test used for registration) (4) Platelet count >= 10 x 10000/mm3 (5) Total bilirubin <= 1.5 mg/dL (6) AST <= 100 U/L (7) ALT <= 100 U/L (8) Creatinine clearance >= 50 mL/min Estimated value using the Cockcroft-Gault formula must be >= 50 mL/min/body. If the estimated value is < 50 mL/min/body, eligibility is confirmed if the actual measured value is >= 50 mL/min/body. (9) SpO2 >= 95% (room air) 9) Patient from whom written consent for trial participation can be obtained.
Exclude criteria	1) Active concurrent cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less). However, even if the disease-free period is less than 5 years, a history of cancer with a 5-year relative survival rate of 95% or higher, such as clinical stage I prostate cancer, clinical stage 0 or I laryngeal cancer with complete response to radiation therapy, or completely resected cancer of the following pathological stages, is not included in active concurrent/multiple cancers). Gastric cancer "adenocarcinoma (general type)": Stage 0-I, colon cancer (adenocarcinoma): Stage 0-I, rectal cancer (adenocarcinoma): Stage 0-I, esophageal cancer (squamous cell carcinoma, adenocarcinoma with squamous differentiation, basaloid carcinoma): Stage 0, breast cancer (ductal carcinoma in situ, lobular carcinoma in situ): Stage 0, Breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): Stage 0-IIA, Endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I, Prostate cancer (adenocarcinoma): Stage I-II, Cervical carcinoma (squamous cell carcinoma): Stage 0, Thyroid carcinoma (papillary carcinoma, follicular carcinoma): Stage I, II, III, Renal carcinoma (clear cell carcinoma, chromophobe carcinoma): Stage I, Other mucosal carcinoma-equivalent lesions * Staging follows UICC-TNM 8th Edition or equivalent cancer classification systems as a general rule 2) Patient with an infection requiring systemic treatment. 3) Patient with fever of 38.0 C (100.4 F) or higher at registration. 4) Women who are pregnant, may be pregnant, within 28 days postpartum, or breastfeeding. Men whose partners wish to become pregnant. 5) Patient with a psychiatric disorder or psychiatric symptoms that interfere with daily life, making participation in the trial difficult. 6) Patient receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs. 7) Patient requiring continuous use of one or more of the following: flucytosine, phenytoin, or warfarin potassium. 8) Patient with comorbid unstable angina (angina that has developed or worsened within the last 3 weeks) or a history of myocardial infarction within the last 6 months. 9) Patient with poorly controlled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 10) Patient with poorly controlled hypertension. 11) Patient with poorly controlled diabetes mellitus. 12) Patient complicated by one or more of the following diagnosed by chest CT: interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 13) Patient deemed unsuitable as study subjects by the investigator for other reasons.