NIPH Clinical Trials Search

Juzentaihoto (TJ-48) for Fatigue and Safety in Advanced or Recurrent Gastric/Esophageal/Esophagogastric Junction Cancer Receiving ICI-Combined Chemotherapy: A Prospective Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Gastric Cancer/ Esophageal cancer /Gastroesophageal junction cancer
Date of first enrollment	18/03/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	Oral administration of Juzentaihoto

Outcome(s)

Primary Outcome	FACIT-F at 12 weeks
Secondary Outcome	Recovery RS terminal (HRV; heart rate variability, etc.) FACIT-F, FACT-G Cancer disease progression assessment (RECIST guidelines ver. 1.1) PFS Inflammatory and nutritional indicators

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Patients must be 18 years of age or older at the time of consent. 2. Patients have provided written informed consent to participate in this study. 3. Patients have histologically confirmed esophageal cancer or esophagogastric junction cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma, or adenocarcinoma) or gastric cancer (any of the general histological types) through an endoscopic biopsy from the primary esophageal or gastric lesion. 4. Patients must be clinically stage IV at the time of consent. Patients with Stage II or III cancer who are deemed incurable by the investigator to be unresectable with neoadjuvant therapy may be enrolled. Esophageal Cancer or Esophagogastric Junction Cancer (UICC-TNM 8th Edition) 5. The investigator or co-investigator has determined that immune checkpoint inhibitor combination chemotherapy is clinically appropriate, and has decided to begin first-line treatment for advanced or recurrent disease. The type of regimen is not important. 6. Patients must be able to take Kampo orally or via gastrostomy. Oblate tubes are permitted. 7. Patients with an ECOG performance status (PS) of 0 or 1 who can tolerate chemotherapy. 8. Patients who can be expected to be followed for at least 12 weeks after study enrollment.
Exclude criteria	1. Have received treatment with an immune checkpoint inhibitor. 2. Have received blood transfusions, blood products, or hematopoietic factor preparations such as G-CSF within 14 days prior to enrollment. 3. Have severe drug hypersensitivity to any Kampo. 4. Have an active infection (fever of 38.0 degrees Celsius or higher, and bacterial infection confirmed by diagnostic imaging or bacteriological testing. Local infections that do not affect overall condition are excluded). 5. Have poorly controlled hypertension or diabetes (patients with diabetes well controlled with insulin or antidiabetic drugs are eligible to enroll). 6. Have severe electrocardiogram abnormalities detected by 12-lead electrocardiogram within 28 days prior to enrollment or have clinically severe heart disease. Congestive heart failure, angina pectoris requiring drug therapy, clearly visible intramural myocardial infarction on electrocardiogram, clinically significant valvular heart disease, symptomatic coronary artery disease, poorly controlled arrhythmia, or a history of myocardial infarction within the past 12 months, etc. 7. Patients have interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc. as determined by imaging diagnosis such as CT. 8. Patients have an autoimmune disease or a history of chronic or recurrent autoimmune disease. However, patients with type 1 diabetes, hypothyroidism that can be managed with hormone replacement therapy, and skin diseases that do not require systemic treatment may be enrolled. 9. Patients require systemic corticosteroids (excluding prophylactic administration for testing or allergic reactions, or temporary use) or immunosuppressants. 10. Patients are taking Kampo (however, patients may be enrolled if they stopped taking herbal medicine 4 weeks prior to enrollment and have not taken it since). 11. Patients are diagnosed with psychiatric illness and are deemed unable to participate in the study. 12. Patients have fresh gastrointestinal bleeding requiring repeated blood transfusions. 13. Patients have CTCAE Grade 2 or higher diarrhea or chronic watery stools. 14. Active dual cancer (patients with a history of other cancers that have not shown recurrence for more than 5 years are eligible to enroll). 15. Pregnant or nursing women, or women who may be pregnant, and men whose partners wish to become pregnant. 16. Positive for HBs antigen, HCV antibody, or HIV antibody (registration permitted even if HIV antibody is not tested). Registration permitted even if HBs antigen positive, provided the subject is undergoing treatment with nucleoside analogues and liver function meets clinical laboratory standards. Subjects with a history of hepatitis C who achieved seroconversion through interferon therapy or similar treatment are eligible for registration. 17. Other reasons deemed inappropriate for participation in this trial by the principal investigator or sub-investigator.