Survival , Tumor
Conditions
Keywords
Astragalus polysaccharides, Colorectal cancer, Chemotherapy, Target therapy, Immunomodulator
Brief summary
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.
Interventions
None listed
Sponsors
Chou-Chen Chen
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | From the earliest record until Dec 2030 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | From the earliest record until Dec 2030 | — |
| Distant metastasis free survival | From the earliest record until Dec 2030 | — |
| Progress free survival | From the earliest record until Dec 2030 | — |
| Hematological lab data change | 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 | 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 | Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]). | The CTCAE is the established toxicity scoring system that assigns severity grades (G1 = mild to G5 = death) to Adverse Events (AEs). |
| Fatigue score change | Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]). | 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. |
| Tumor response | Baseline and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]). | — |
Countries
Taiwan
Contacts
CONTACTChou-Chen Chen
Outcome results
None listed