What is a clinical trial?
Before a new drug is released to the market, it takes a long time and a lot of research and testing.
New drugs developed by pharmaceutical companies require approval from the Ministry of Health, Labor and Welfare, and clinical trials are conducted to obtain this approval. Clinical trials are conducted in accordance with standards set by the Ministry of Health, Labor and Welfare (standards for conducting clinical trials of pharmaceuticals). Clinical trials for anticancer drugs have the following stages (phases), and development proceeds in order, with safety and efficacy being confirmed at each stage.
Phase I
We examine how candidate drug substances behave in the body and whether their side effects are tolerable and can be used without problems.
Phase II
A relatively small number of patients are studied to examine the efficacy and safety of a drug candidate.
The dosage and method of administration will be considered.
Phase III
This is a relatively large-scale trial, involving a larger number of patients than Phase II trials.
Typically, the study will compare the treatment with the current standard of care.
Phase IV
These are conducted after a drug has been approved by the Ministry of Health, Labor and Welfare and is on the market, and are called "post-marketing clinical trials."
We will post information about cancer clinical trials being conducted at our hospital.
Not everyone can participate in clinical trials. Each clinical trial has its own conditions, so please inquire with the relevant department.
Clinical Trials and Research Center website also provides information about clinical trials.
Current (publicly available) cancer clinical trials
As of May 1, 2026
| Clinical department | Target diseases and indications | Assignment name |
| Hematology-oncology | acute lymphoblastic leukemia | Amgen sponsored Phase III study of blinatumomab in patients with acute lymphoblastic leukemia |
| Hematology-oncology | acute leukemia | A Phase 1/2 study of DSP-5336 for acute leukemia sponsored by Sumitomo Dainippon Pharma Co., Ltd. |
| Hematology-oncology | Aggressive NK cell leukemia | Phase I/II study of PPMX-T003 for patients with aggressive NK cell leukemia, submitted by Dr. Masahito Onizuka Hematology-oncology |
| Hematology-oncology | Relapsed or refractory B-cell malignancies | The MK-2140-006 basket trial, sponsored by MSD K.K., evaluating MK-2140 as monotherapy and combination therapy in patients with B-cell malignancies |
Breast Surgery |
Programmed death-ligand (PD-L1) positive locally recurrent, unresectable or metastatic triple-negative breast cancer |
TROPION-Breast05 is a phase III open-label randomized trial commissioned by Daiichi Sankyo Co., Ltd. to compare datopotamab deruxtecan (Dato-DXd) monotherapy or combination therapy with durvalumab with physician-selective chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) and pembrolizumab in patients with locally recurrent, unresectable, or metastatic triple-negative breast cancer that is positive for the Programmed Death-Ligand (PD-L1). |
Otolaryngology/Head and Neck Surgery |
Unresectable locally advanced squamous cell carcinoma of the head and neck |
Phase III trial of GSK4057190A (Dostarlimab) in patients with unresectable locally advanced head and neck squamous cell carcinoma, commissioned by GlaxoSmithLine K.K. |
Breast Surgery |
Patients with advanced breast cancer who have BRCA1, BRCA2, or PALB2 mutations, and who are HR-positive and HER2-positive (IHC 0.1⁺, 2⁺/ISH negative). |
A Phase III trial of Saruparid (AZD5305) plus camizestrant in HR-positive, HER2-negative patients with advanced breast cancer, commissioned by AstraZeneca K.K. |
Breast Surgery |
Triple-negative breast cancer that has not achieved pathological complete response |
A Phase III trial commissioned by MSD K.K. to compare MK-2870 plus pembrolizumab with investigator-selected treatment in patients with triple-negative breast cancer who have not achieved a pathological complete response. |
Breast Surgery |
Metastatic cancer patients |
Phase Ib and Phase II clinical trials of zongertinib (BI1810631) in combination with trastuzumab deruxtecan or trastuzumab emtansine in patients with metastatic cancer, commissioned by IQViA Services Japan Co., Ltd. (Domestic Clinical Trial Administrator) |
Breast Surgery |
Unresectable or metastatic triple-negative breast cancer (PD-L1CSP < 10) |
A Phase 3 trial commissioned by MSD K.K. to compare MK-2870 (sac-TMT) monotherapy with MK-3475 (pembrolizumab) combination therapy as first-line treatment for unresectable or metastatic triple-negative breast cancer (PD-L1CPS <10), compared with treatment selected by the investigator. |
| Hematology-oncology | B-cell Hodgkin lymphoma |
Phase II clinical trial of Glofitamab (R07082859) in patients with B-cell non-Hodgkin lymphoma, commissioned by Chugai Pharmaceutical Co., Ltd. |
| Breast Surgery | Locally advanced or metastatic solid cancer Unresectable or recurrent breast cancer with PIK3CA mutation, hormone receptor-positive, HER2-negative. |
Chugai Pharmaceutical shares purchased in a Phase I/II trial at the request of a physician. |
| Breast Surgery | Hormone-positive/HER2-negative advanced or metastatic breast cancer |
A Phase 3 trial commissioned by Pfizer Inc., targeting patients with hormone receptor markers/HER2-negative advanced or metastatic breast cancer. |
gynecology |
uterine cancer |
Phase II/III trial of AZD0825 in endometrial cancer patients, commissioned by AstraZeneca K.K. |
Hematology-oncology |
Multiple myeloma |
Phase II/III trial of Etentaming in patients with multiple myeloma, commissioned by AbbVie LLC. |
| Breast Surgery | Patients with PIK3CA mutations, endocrine-sensitive hormone receptor-positive, HER2-negative breast cancer |
A Phase III trial of inavolisib (R07113755) in patients with PIK3CA mutations, endocrine-sensitive hormone receptor-positive, HER2-negative breast cancer, commissioned by Chugai Pharmaceutical Co., Ltd. |
| Breast Surgery | Patients with HER2-positive locally advanced or metastatic breast cancer |
Phase III trial of inavolisib (R07113755) in patients with HER2-positive locally advanced or metastatic breast cancer, commissioned by Chugai Pharmaceutical Co., Ltd. |
Neurosurgery |
Primary glioblastoma |
(Domestic Clinical Trial Administrator) A Phase III, randomized, double-blind, placebo-controlled trial commissioned by Novocure Inc. to investigate the combination of the NovoTTF-100A system (TT field: 200kHz), temozolomide maintenance therapy, and pembrolizumab as a treatment for newly diagnosed glioblastoma, compared to the combination of the NovoTTF-100A system, temozolomide maintenance therapy, and placebo. |
Gastroenterological Surgery |
Solid cancer |
REGN7508 (ROXI-CAT-I) as primary prevention of CAT in patients with solid tumors, as requested by Regeneron Japan Co., Ltd. |
| Hematology-oncology | Multiple myeloma |
Phase III trial of LINVOSELTAMAB (REGN5458) for multiple myeloma, commissioned by Parexel International Co., Ltd. (domestic clinical trial administrator). |