UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055617 |
|---|---|
| Receipt number | R000063543 |
| Scientific Title | Observational study for conversion rate to surgery in the patients who are planned to be treated with Durvalumab with Gemcitabine plus Cisplatin due to unresectable biliary tract cancers by locally advance or oligo-metastasis (GC-D conversion study) CSGO-HBP024 |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2024/09/25 16:56:55 |
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Basic information
Public title
Observational study for conversion rate to surgery in the patients who are planned to be treated with Durvalumab with Gemcitabine plus Cisplatin due to unresectable biliary tract cancers by locally advance or oligo-metastasis (GC-D conversion study) CSGO-HBP024
Acronym
CSGO-HBP024
Scientific Title
Observational study for conversion rate to surgery in the patients who are planned to be treated with Durvalumab with Gemcitabine plus Cisplatin due to unresectable biliary tract cancers by locally advance or oligo-metastasis (GC-D conversion study) CSGO-HBP024
Scientific Title:Acronym
CSGO-HBP024
Region
| Japan |
Condition
Condition
to investigate conversion rate to surgery in the patients who are treated with gemcitabine, cisplatin, and durvalumab (GC-D)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess conversion rate in locally advanced or oligo-metastatic BTC treated with GC-D
Basic objectives2
Others
Basic objectives -Others
1. R0 resection rate
2. Period to conversion
3. Morbidities after surgery (Clavien-dindo classification, more than grade 3).
4. Overall survival
5. Progression-free survival
6. Immune cell related antigen on tumor and tumor micro environment
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The conversion rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Locally advanced / oligo-metastastatic / recurrent biliary tract cancer.
2.Pathologically proven BTC
3.Age >=18
4.PS 0 or 1
5.Adequate organ and marrow function (see TOPAZ-1[3])
Neutrophil >=1500/uL
Platelet >=10x104/uL
Bilirubin =<2.5 xthe upper limit of normal (ULN).
ALT, AST =<2.5 x ULN
Measured creatinine clearance >50 mL/min or calculated creatinine clearance >50 mL/min as determined by Cockcroft-Gault (using actual body weight):
6.Written informed consent
Key exclusion criteria
1.Treatments, e.g. chemotherapy, radiation, surgical procedures, for target lesions prior to the enrolment
2.Severe complication (e.g. interstitial pneumonia, pulmonary fibrosis, cardiac failure, liver failure, bleeding peptic ulcer, ileus, uncontrollable diabetes mellitus, immunodeficiency, immune-related diseases, uncontrollable infectious diseases)
3.Moderate or severe pulmonary effusion or ascites
4.Metastasis to central nerves system
5.Active primary malignancy in the other organs
6.Pregnant or possible pregnant or breastfeeding
7.Psychiatric disorder
8.Drug allergy for GC-D
9.Other reasons to be excluded from the study by investigators' judgement.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Kobayashi |
Organization
Clinical Study Group of Osaka University
Division name
Hepato-Biliary-Pancreatic Group
Zip code
5650871
Address
2-2E2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3251
s-kobayashi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Kobayashi |
Organization
Clinical Study Group of Osaka University
Division name
Hepato-Biliary-Pancreatic Group
Zip code
565-0871
Address
2-2E2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3251
Homepage URL
s-kobayashi@umin.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Astra Zeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
2-15Yamadaoka, Suita
Tel
06-6879-3251
s-kobayashi@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
to investigate conversion rate to surgery in the patients who are treated with gemcitabine, cisplatin, and durvalumab (GC-D)
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063543
