Cheng Ching General Hospital, Chung Kang Branch
Taichung, 40764, Taiwan
Location status: Recruiting
NCT Number: NCT07703709
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.
Interested in participating?
Request Info20 year and older
All sexes
Observational
Taichung, 40764, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From the earliest record until Dec 2030
Time frame: From the earliest record until Dec 2030
Time frame: From the earliest record until Dec 2030
Time frame: From the earliest record until Dec 2030
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]).
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]).
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]).
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]).
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 and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).
Contact information is provided by the study sponsor or research team.
Chou-Chen Chen
Other
Clinical Outcomes of Treatment With Immunomodulator Plus Standard Anti-cancer Therapies for Patients With Colorectal Cancer: A Real-World Study
Acronym: CROSS-02
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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