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Colorectal CancerNCT07527832

An Observational Study to Learn About the Medicine - BEVACIZUMAB BS [Pfizer] in Colorectal Cancer Patients From Japan.

An observational study of Colorectal Cancer, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to look at the safety of BEVACIZUMAB BS [Pfizer] when it was used to colorectal cancer patients in real-world clinical setting in Japan. The study population includes individuals who have a diagnosis of colorectal cancer and have been treated with Bevacizumab-Pfizer Biosimilar or Avastin… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Bevacizumab-Pfizer Biosimilar and Avastin
How many people
1,000 participants
Where
1 siteJapan
Study dates
20 Apr 2026to 27 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population includes individuals who have a diagnosis of colorectal cancer and have been treated with Bevacizumab-Pfizer Biosimilar or Avastin within a planned study period between 1 December 2019 and 30 November 2024.

Who may be able to join

  • Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
  • Having definitive diagnosis code of colorectal cancer [International Classification of Diseases (ICD)-10 code: C18, C19 or C20] on the index month or within 6 months before index month [-6 month to 0 month (index month)]. An inpatient or outpatient visit assigned a diagnosis code consistent with colorectal cancer using ICD-10 coding:
  • Malignant neoplasm of colon: C18
  • Malignant neoplasm of rectosigmoid junction: C19
  • Malignant neoplasm of rectum: C20
  • Having at least one medical record between 180 days and 1 day before the index date (Day -180 to -1) and having at least one medical record prior to 181 days before the index date (Day -181 and before)
Show all 27Show fewer
  • 15 years of age or older at the index date (Day 0)
  • Exclusion criteria Patients meeting any of the following criteria will not be included in the study.
  • "Common"
  • Having initial prescriptions for Bevacizumab-Pfizer biosimilar and Avastin on the same date (index date for both drugs being identical)
  • Having the prescription of Other Bevacizumab Biosimilars on the same date as the earlier index date of Bevacizumab-Pfizer biosimilar or Avastin
  • "Haemorrhage"
  • Have definitive diagnosis code of major haemorrhage between 180 days and 1 day before the index date (Day -180 to 1): between 6 months and 1 month before the month in which the index date is included (Month -6 to -1) Major haemorrhage: basic condition and any of additional conditions (2, 5 or 6). The outcome incidence date is the earliest date of the composite criteria between 180 days and 1 day before the index date (Day -180 to 1): between 6 months and 1 month before the month in which the index date is included (Month -6 to -1)
  • Have diagnosis code of minor haemorrhage between 30 days and 1 day before the index date (Day -30 to -1): 1 month before the month in which the index date is included (Month -1) Minor haemorrhage: basic condition and any of additional conditions (1, 3 or 4). The outcome incidence date is the earliest date of the composite criteria between 30 days and 1 day before the index date (Day -30 to -1): 1 month before the month in which the index date is included (Month -1)
  • "Hypertension, hypertensive crisis" Have definitive diagnosis code of "hypertension, hypertensive crisis" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Proteinuria, nephrotic syndrome" Have definitive diagnosis code of "proteinuria, nephrotic syndrome" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Bone-marrow depression" Have definitive diagnosis code of "bone-marrow depression" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Arterial thromboembolism" Have definitive diagnosis code of "arterial thromboembolism" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Cardiac failure congestive" Have definitive diagnosis code of "cardiac failure congestive" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Wound healing delayed" Have definitive diagnosis code of "wound healing delayed" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Gastrointestinal perforation" Have definitive diagnosis code of "gastrointestinal perforation" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Venous thromboembolism" Have definitive diagnosis code of "venous thromboembolism" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Fistula" Have definitive diagnosis code of "fistula" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Shock, anaphylaxis, hypersensitivity reactions, infusion reaction" Have definitive diagnosis code of "shock, anaphylaxis, hypersensitivity reactions, infusion reaction" between 180 days and 1 day before index date (Day -180 to -1): between 6 months and 1 month before the month in which the index date is included (Month -6 to -1)
  • "Interstitial pneumonia" Have definitive diagnosis code of "interstitial pneumonia" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Cardiac disorders (excluding "cardiac failure congestive" and "arterial thromboembolism")" Have definitive diagnosis code of "cardiac disorders (excluding "cardiac failure congestive" and "arterial thromboembolism") before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
  • "Infections" Have a date of hospitalization due to infection and definitive diagnosis code of "infections" between 180 days and 1 day before index date (Day -180 to -1)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Pfizer

    Tokyo

Other trials in Japan

About this study

Official title: BEVACIZUMAB BS INTRAVENOUS INFUSION 100MG, 400MG [PFIZER] POST-MARKETING DATABASE STUDY

The purpose of this study is to look at the safety of BEVACIZUMAB BS [Pfizer] when it was used to colorectal cancer patients in real-world clinical setting in Japan.

The study population includes individuals who have a diagnosis of colorectal cancer and have been treated with Bevacizumab-Pfizer Biosimilar or Avastin between 1 December 2019 and 30 November 2024.

Data source is the Medical Data Vision (MDV) database - a hospital-based claims database in Japan.

Being tested
Bevacizumab-Pfizer Biosimilar, Avastin
Keywords
colorectal cancer, Bevacizumab-Pfizer Biosimilar, haemorrhage, Japan
Medical subject headings
Colorectal Neoplasms, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab-Pfizer BiosimilarDrug

    As provided in real world practice

  • AvastinDrug

    As provided in real world practice

Study groups in NCT07527832
Study groupRoleWhat they receive
Exposed group in Comparative Analysis Set1. All patients treated with Bevacizumab-Pfizer Biosimilar between 1 December 2019 and 30 November 2024. The first prescription date is set as the index date (Day 0). AND 2. Patients without any use of Bevacizumab product (Avastin, Bevacizumab-Pfizer Biosimilar, other Bevacizumab Biosimilars) before index date.
Receives: Drug: Bevacizumab-Pfizer Biosimilar
Control group in Comparative Analysis Set1. All patients treated with Avastin between 1 December 2019 and 30 November 2024. The first prescription date is set as the index date (Day 0). AND 2. Patients without any use of Bevacizumab product (Avastin, Bevacizumab-Pfizer Biosimilar, other Bevacizumab Biosimilars) before index date.
Receives: Drug: Avastin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of "haemorrhage"

    Measured: From index date (Day 0) up to 90 days after last prescription

Secondary outcomes (13)

  1. Incidence rate of "hypertension, hypertensive crisis"

    Measured: From index date (Day 0) up to 90 days after last prescription

  2. Incidence rate of "proteinuria, nephrotic syndrome"

    Measured: From index date (Day 0) up to 90 days after last prescription

  3. Incidence rate of "bone-marrow depression"

    Measured: From index date (Day 0) up to 90 days after last prescription

  4. Incidence rate of "arterial thromboembolism"

    Measured: From index date (Day 0) up to 90 days after last prescription

  5. Incidence rate of "cardiac failure congestive"

    Measured: From index date (Day 0) up to 90 days after last prescription

  6. Incidence rate of "wound healing delayed"

    Measured: From index date (Day 0) up to 90 days after last prescription

  7. Incidence rate of "gastrointestinal perforation"

    Measured: From index date (Day 0) up to 90 days after last prescription

  8. Incidence rate of "venous thromboembolism"

    Measured: From index date (Day 0) up to 90 days after last prescription

  9. Incidence rate of "fistula"

    Measured: From index date (Day 0) up to 90 days after last prescription

  10. Incidence rate of "shock, anaphylaxis, hypersensitivity reactions, infusion reaction"

    Measured: From index date (Day 0) up to next day after last prescription

  11. Incidence rate of "interstitial pneumonia"

    Measured: From index date (Day 0) up to 90 days after last prescription

  12. Incidence rate of "cardiac disorders (excluding "cardiac failure congestive" and "arterial thromboembolism")"

    Measured: From index date (Day 0) up to 90 days after last prescription

  13. Incidence rate of "infections"

    Measured: From index date (Day 0) up to 90 days after last prescription

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start20 Apr 2026
  3. Primary completion27 May 2026
  4. Study completion27 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527832
Sponsor's protocol ID
B7391010
Status last verified
Jun 2026
First submitted
7 Apr 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of "haemorrhage" (time frame: From index date (Day 0) up to 90 days after last prescription). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07527832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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