Menu
Recruiting NCT06557668

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

Observational Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Primary outcome measures

  • Overall survival [Time frame: From the initial treatment until April 2024]
Secondary outcome measures (2)
  • Progress free survival [Time frame: From the initial treatment until April 2024]
  • Tumor response [Time frame: From the initial treatment until April 2024]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 2 centers
  • Chung-Shan Medical University Hospital — Taichung
  • Taichung Veterans General Hospital — Taichung

Identifiers

NCT: NCT06557668 · APS-CRC01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗