An observational study in Survival , Tumor, sponsored by Chou-Chen Chen. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Chou-Chen Chen · Observational
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 60 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Chou-Chen Chen as lead sponsor.
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Patients diagnosed with and treated for colorectal cancer at Cheng Ching General Hospital, Chung Kang Branch, Taiwan
Exclusion Criteria:
Immunomodulator (APS Injection) plus standard anti-cancer therapies
Standard anti-cancer therapies
Overall survival
Time frame: From the earliest record until Dec 2030
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
The CTCAE is the established toxicity scoring system that assigns severity grades (G1 = mild to G5 = death) to Adverse Events (AEs).
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
Visual Analogue Scale (VAS) will be used for the scoring of patients' fatigue. On a scale of 0 to 10, with 0 meaning no fatigue and 10 meaning the worst fatigue.
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]).
Plan to share: No
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