UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057763 |
|---|---|
| Receipt number | R000066016 |
| Scientific Title | Is Addition of Immune Checkpoint Inhibitors to Chemotherapy plus Bevacizumab Effective in Metastatic Colorectal Cancer? A Systematic Review and Meta-Analysis of Randomized Controlled Study |
| Date of disclosure of the study information | 2025/05/03 |
| Last modified on | 2025/05/03 09:28:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Is Addition of Immune Checkpoint Inhibitors to Chemotherapy plus Bevacizumab Effective in Metastatic Colorectal Cancer? A Systematic Review and Meta-Analysis of Randomized Controlled Study
Acronym
Is Addition of Immune Checkpoint Inhibitors to Chemotherapy plus Bevacizumab Effective in Metastatic Colorectal Cancer? A Systematic Review and Meta-Analysis of Randomized Controlled Study
Scientific Title
Is Addition of Immune Checkpoint Inhibitors to Chemotherapy plus Bevacizumab Effective in Metastatic Colorectal Cancer? A Systematic Review and Meta-Analysis of Randomized Controlled Study
Scientific Title:Acronym
Is Addition of Immune Checkpoint Inhibitors to Chemotherapy plus Bevacizumab Effective in Metastatic Colorectal Cancer? A Systematic Review and Meta-Analysis of Randomized Controlled Study
Region
| Japan |
Condition
Condition
metastatic and/or unresectable colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the additional efficacy of ICI on chemotherapy plus bevacizumab in metastatic colorectal cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression-free survival
Key secondary outcomes
overall survival, objective response rate, and serious adverse event
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) diagnosed as metastatic and/or unresectable colorectal cancer, (ii) RCTs comparing cytotoxic chemotherapy plus bevacizumab with or without immune check point inhibitor
Key exclusion criteria
Studies investigating pediatric patients, animal studies, and not evaluating predefined outcomes were excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Akihisa |
| Middle name | |
| Last name | Matsuda |
Organization
Nippon Medical School
Division name
Gastroenterological Surgery
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo, Tokyo, Japan
TEL
0338222131
a-matsu@nms.ac.jp
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Matsuda |
Organization
Nippon Medical School
Division name
Gastroenterological Surgery
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo, Tokyo, Japan
TEL
0338222131
Homepage URL
a-matsu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Akihisa Matsuda
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo, Tokyo, Japan
Tel
0338222131
a-matsu@nms.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 03 | 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
986
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The inclusion and exclusion criteria were defined a priori. The inclusion criteria were as follows: (i) diagnosed as metastatic and/or unresectable CRC, (ii) RCTs comparing cytotoxic chemotherapy plus bevacizumab with or without ICI. The primary outcome was progression-free survival (PFS), and secondary outcomes were overall survival (OS), and objective response rate (ORR), and serious adverse event (AE) (grade 3 or more). Studies investigating pediatric patients, animal studies, and not evaluating predefined outcomes were excluded. Each extracted study was evaluated by two independent investigators (F.A. and A.M.) for inclusion and exclusion. The following data were extracted from the included studies: author, year, country, study design, institutions, study duration, and number and characteristics of patients.
Management information
Registered date
| 2025 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066016
