Yamaguchi University Clinical Trial Information

We would like to introduce a clinical trial at Yamaguchi University. Clinical trials, as the name implies, are studies designed to test whether a particular approach can improve a patient's condition. Under regulations in each country, drugs and medical interventions must be confirmed safe through clinical trials before they can be administered to patients.

As a side note: current PD-1 immune checkpoint drugs work by blocking the interaction between immune cells and cancer cells. An interesting question arises — could genetically modifying immune cells directly achieve results comparable to immune cell therapy, at a lower cost than the current 300,000–400,000 NTD per injection? This is merely a thought for consideration.

Returning to the main topic: Yamaguchi University began two clinical trials on March 24, 2016:

Trial 1: Peptide vaccine + combined immunotherapy for patients with esophageal cancer, gastric cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer, or breast cancer. Accepting several dozen patients.

Trial 2: Peptide vaccine + combined immunotherapy specifically for colorectal cancer patients with no remaining treatment options. Also recruiting several dozen volunteers.

Minimum eligibility criteria for consultation:

1. Confirmed diagnosis of pancreatic cancer, colorectal cancer, gastric cancer, esophageal cancer, hepatocellular carcinoma, or breast cancer.
2. Standard treatments have been ineffective.
3. HLA-A*2402, HLA-A*0201, or HLA-A*0206 positive (at least one).
4. Estimated survival time of 3 months or more after consultation.
5. Age 20 or older.
6. ECOG Performance Status 0–1.
7. Able to provide imaging records within 28 days prior to application confirming disease status.
8. Has received prior chemotherapy, immunotherapy, or radiation therapy.
9. At least 2 weeks after prior treatment.
10. Blood test results within 14 days of application must meet all of the following:

• Hemoglobin: ≥8.0 g/dL
• WBC count: ≥3,000/mm³
• Lymphocytes: ≥15%
• Platelet count: ≥75,000/mm³
• Total bilirubin: ≤2.0 mg/dL (≤3.0 mg/dL if prior jaundice treatment)
• AST (GOT)/ALT (GPT): ≤2.5× upper limit of normal
• Creatinine: within upper limit of normal

1. Patient understands and is willing to undergo this therapy.

Exclusion criteria:

1. Duplicate cancer (disease-free period within 1 year).
2. Suspected or confirmed interstitial lung disease (ILD) or pulmonary adenofibrosis.
3. Brain metastases confirmed or suspected.
4. Suspected or confirmed active infection.
5. Severe psychiatric disorder.
6. Uncontrollable cardiopulmonary, renal, or hepatic disease, or other serious comorbidities.
7. History of myocardial infarction, stroke, pulmonary embolism, or other major vascular events within 12 months.
8. Currently receiving or planning to receive corticosteroids, immunosuppressants, or immunoactivating agents.
9. Uncontrollable external lesions.
10. Pregnancy plans (male or female) or currently pregnant/breastfeeding females.
11. Deemed unsuitable by the physician.

This therapy uses peptide vaccines combined with composite immunotherapy. Interested patients may contact the hospital directly:

• Hospital consultation: +81-836-22-2324
• Address: 1-1-1 Minamikogushi, Ube City 755-8505
• Tel: +81-836-22-2264 | Fax: +81-836-22-2263 | Email: surg2@yamaguchi-u.ac.jp

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

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Related Cancer Information

• Breast cancer
• Colorectal cancer
• Gastric cancer
• Liver cancer
• Pancreatic cancer