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NCT Number: NCT07703709

Colorectal Cancer Real-world Outcomes Study of Survival With Immunomodulator Plus Standard Anti-cancer Therapies

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.

Recruiting

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cheng Ching General Hospital, Chung Kang Branch

Taichung, 40764, Taiwan

Location status: Recruiting

Location contact

Chou-Chen Chen

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: From the earliest record until Dec 2030

Secondary outcomes

  1. Disease free survival

    Time frame: From the earliest record until Dec 2030

  2. Distant metastasis free survival

    Time frame: From the earliest record until Dec 2030

  3. Progress free survival

    Time frame: From the earliest record until Dec 2030

  4. 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]).

  5. 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]).

  6. 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]).

    The CTCAE is the established toxicity scoring system that assigns severity grades (G1 = mild to G5 = death) to Adverse Events (AEs).

  7. 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]).

    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.

  8. Tumor response

    Time frame: Baseline and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).

Study contacts

Contact information is provided by the study sponsor or research team.

Chou-Chen Chen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Chou-Chen Chen

Other

Registry information

Official study title

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

Acronym: CROSS-02

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 14, 2026
Registry last updated
Jul 17, 2026

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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