Colorectal Cancer Real-world Outcomes Study of Survival With Immunomodulator Plus Standard Anti-cancer Therapies
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: Survival , Tumor. 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 →
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Official title
Clinical Outcomes of Treatment With Immunomodulator Plus Standard Anti-cancer Therapies for Patients With Colorectal Cancer: A Real-World Study
Overview
Colorectal cancer (CRC) is the third most common cancer worldwide. Despite the availability of numerous standard therapies for CRC, clinical outcomes from these treatments remain unsatisfactory. 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 would be an efficient approach for cancer treatment. Astragalus polysaccharide (APS) Injection is an immunomodulator, which can enhance anti-tumor efficacy through regulation of TME. This drug has been approved as a prescription drug for alleviating cancer-related fatigue by the Taiwan Food and Drug Administration (TFDA). In this real-world study, clinical data will be collected both retrospectively and prospectively from the medical records of CRC patients undergoing anti-cancer treatment who did or did not receive immunomodulators. It can be used to understand the possible clinical benefit of immunomodulator plus anti-cancer therapies for patients with CRC, and physicians can refer to these results to give patients the suitable treatment recommendations.
Primary outcome measures
- Overall survival [Time frame: From the earliest record until Dec 2030]
Secondary outcome measures (8)
- Disease free survival [Time frame: From the earliest record until Dec 2030]
- Distant metastasis free survival [Time frame: From the earliest record until Dec 2030]
- Progress free survival [Time frame: From the earliest record until Dec 2030]
- Hematological lab data change [Time frame: Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).]
- Weight loss [Time frame: Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).]
- Common Terminology Criteria for Adverse Events (CTCAE) Toxicities [Time frame: Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).]
- Fatigue score change [Time frame: Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).]
- Tumor response [Time frame: Baseline and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).]
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 Jan 01 2025 and Dec 31, 2027
Exclusion criteria
- Non
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 · 1 center
- Cheng Ching General Hospital, Chung Kang Branch — Taichung
Identifiers
NCT: NCT07703709 · APS-CRC02