Colorectal Cancer Real-world Outcomes Study of Survival With Immunomodulator Plus Standard Anti-cancer Therapies (CROSS-02)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Survival , Tumor

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Chou-Chen Chen; Email: ccchen24615237@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 40764
    • Recruiting
    • Cheng Ching General Hospital, Chung Kang Branch
    • Contact: Chou-Chen Chen; Email: ccchen24615237@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with and treated for colorectal cancer at Cheng Ching General Hospital, Chung Kang Branch, Taiwan

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Treatment; Immunomodulator (APS Injection) plus standard anti-cancer therapies
Control; Standard anti-cancer therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	From the earliest record until Dec 2030

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The CTCAE is the established toxicity scoring system that assigns severity grades (G1 = mild to G5 = death) to Adverse Events (AEs).	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.	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		Baseline and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).

Collaborators and Investigators

• Sponsor: Chou-Chen Chen

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal cancer; Immunomodulator; Chemotherapy; Target therapy; Astragalus polysaccharides
• Additional Relevant MeSH Terms: Neoplasms by Site; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: APS-CRC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No