UMIN-ICDS Clinical Trial

Public title

Clinical Outcomes and Safety of Perioperative Durvalumab Plus Gemcitabine-Cisplatin Therapy for Muscle-Invasive Bladder Cancer: A Study at Shinshu University and Kagawa University

Acronym

Shinshu-Kagawa Study-1

Scientific Title

Clinical Outcomes and Safety of Perioperative Durvalumab Plus Gemcitabine-Cisplatin Therapy for Muscle-Invasive Bladder Cancer: A Study at Shinshu University and Kagawa University

Scientific Title:Acronym

Shinshu-Kagawa Study-1

Region

Japan

Condition

Muscle-Invasive Bladder Cancer (MIBC)

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the real-world effectiveness and safety of perioperative durvalumab plus GC therapy for muscle-invasive bladder cancer at Shinshu University and Kagawa University.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) Event-free survival (EFS):
Defined as the time from the date of initiation of first treatment (with the start date of durvalumab administration as the reference date) to the date of the first occurrence of any of the following:
(a) Disease progression precluding radical cystectomy (based on radiologic assessment or clinical judgment)
(b) Failure to undergo radical cystectomy (due to medical reasons or patient decision)
(c) First recurrence after surgery (local recurrence or distant metastasis)
(d) Death from any cause

2) Pathological complete response (pCR) rate: Defined as ypT0N0 in the radical cystectomy specimen.

Key secondary outcomes

3) Overall survival (OS):
Defined as the time from the date of initiation of first treatment (with the start date of durvalumab administration as the reference date) to the date of death from any cause.

4) Recurrence-free survival (RFS):
Defined as the time from the date of surgery to the first radiologic or pathologic evidence of local recurrence.

5) Metastasis-free survival (MFS):
Defined as the time from the date of surgery to the first radiologic or pathologic evidence of distant recurrence.

6) Pathological downstaging rate:
Defined as <ypT2N0 in the radical cystectomy specimen.

7) Treatment completion rate:
Defined as the proportion of patients who completed four cycles of preoperative therapy, and the proportion of patients who initiated and completed postoperative durvalumab therapy.

8) Surgery completion rate:
Defined as the proportion of patients who underwent radical cystectomy.

9) Time from treatment initiation to surgery:
Defined as the time from the date of initiation of first treatment to the date of surgery.

10) Adverse events:
Evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE).

11) Perioperative complications:
Evaluated according to the Clavien-Dindo classification.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Age >18 years, regardless of sex.

2. Clinically diagnosed muscle-invasive bladder cancer (cT2-4a, N0/1, M0).

3. Histologically confirmed urothelial carcinoma, irrespective of the presence of variant histology.

4. Judged to be clinically eligible for radical cystectomy with curative intent.

5. No prior treatment with systemic chemotherapy.

6. No severe renal dysfunction, defined as eGFR or creatinine clearance >40 mL/min.

7. Scheduled to undergo perioperative durvalumab plus gemcitabine/cisplatin (GC) therapy.

Key exclusion criteria

1. Histological subtypes other than urothelial carcinoma, including squamous cell carcinoma and adenocarcinoma.

2. Active autoimmune disease.

3. Known hypersensitivity or allergy to any of the study drugs.

4. Refusal of data sharing/provision by the patient or the patient's family.

5. Any other condition that, in the judgment of the principal investigator, renders the patient unsuitable for participation in the study.

Target sample size

100

Name of lead principal investigator

1st name	Masashi
Middle name
Last name	Shiozaki

Organization

Shinshu University School of Medicine

Division name

Department of Urology

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2661

Email

m-shiozaki@shinshu-u.ac.jp

Name of contact person

1st name	Masashi
Middle name
Last name	Shiozaki

Organization

Shinshu University School of Medicine

Division name

Department of Urology

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2661

Homepage URL

Email

m-shiozaki@shinshu-u.ac.jp

Institute

Shinshu University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shinshu University School of Medicine Biological and Medical Research Ethics Committee

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

Tel

0263-37-3099

Email

mdrinri@shinshu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2026

Year

01

Month

10

Day

Date of IRB

2026

Year

03

Month

08

Day

Anticipated trial start date

2026

Year

03

Month

17

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The primary objective of this study is to evaluate the real-world effectiveness of perioperative durvalumab plus gemcitabine and cisplatin chemotherapy (the NIAGARA regimen) for muscle-invasive bladder cancer at Shinshu University and Kagawa University, based on event-free survival (EFS) and pathological complete response (pCR).
The secondary objectives of this study are:
1. To evaluate the safety of perioperative durvalumab plus gemcitabine and cisplatin chemotherapy, including adverse events, immune-related adverse events, and perioperative complications, as well as the treatment completion rate and the proportion of patients undergoing surgery.
2. To evaluate clinical outcomes, including overall survival (OS), recurrence-free survival (RFS), and metastasis-free survival (MFS).
3. To explore the associations of immunohistochemical markers in surgical specimens, including tumor-infiltrating lymphocytes and PD-L1 expression, with treatment response, including pathological complete response (pCR) and pathological downstaging, and prognosis.

Registered date

2026

Year

07

Month

16

Day

Last modified on

2026

Year

07

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069683