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NCT Number: NCT06557668

Clinical Outcomes of Treatment With Immunomodulator Plus Cancer Therapies for Patients With Colorectal Cancer

This study aims to evaluate the survival and treatment outcomes among colorectal cancer patients undergoing anti-cancer treatment, both with and without an immunomodulator.

Recruiting

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chung-Shan Medical University Hospital, Taichung, Taiwan

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About this study

Colorectal cancer (CRC) is the third most common cancer worldwide. The clinical outcomes from CRC treatments are often unsatisfactory for the majority of patients. The tumor microenvironment (TME) plays an important role to regulate tumor growth, progression, and metastasis and can limit the efficacy of cancer therapies. Therefore, targeting TME could provide an efficient approach for cancer treatment.

Astragalus Polysaccharide Injection, an immunomodulator, which can stimulate medullary hematopoiesis and enhance immune function. It also can modulate TME. Astragalus Polysaccharide Injection has been approved as a prescription drug for alleviating cancer-related fatigue by the Taiwan Food and Drug Administration (TFDA).

In this retrospective study, we will collect clinical data and survival status of colorectal cancer patients undergoing anti-cancer treatment from their medical records with and without immunomodulator, Astragalus polysaccharide Injection. It can be used to understand the possible clinical benefit of immunomodulator plus anti-cancer therapies for patients with colorectal cancer, and physicians can refer to these results to give patients the suitable treatment recommendations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 20 years and older.
  • Patients who have been given a diagnosis of colorectal cancer.
  • Patients had previously initiated anti-cancer therapies between January 1, 2020, and Apr 30, 2024.

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: From the initial treatment until April 2024

Secondary outcomes

  1. Progress free survival

    Time frame: From the initial treatment until April 2024

  2. Tumor response

    Time frame: From the initial treatment until April 2024

Study contacts

Contact information is provided by the study sponsor or research team.

Chou-Chen Chen, M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Clinical Outcomes of Treatment With Immunomodulator Plus Standard Anti-cancer Therapies for Patients With Colorectal Cancer: A Retrospective Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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