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

NCT07703709 | Recruiting

• 1 other identifier: APS-CRC02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Survival , Tumor

Keywords

Astragalus polysaccharides; Colorectal cancer; Chemotherapy; Target therapy; Immunomodulator

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the earliest record until Dec 2030

Secondary Outcomes (8)

• 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]).

Study Arms (2)

Treatment

Immunomodulator (APS Injection) plus standard anti-cancer therapies

Control

Standard anti-cancer therapies

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Non

Sponsors & Collaborators

• Chou-Chen Chen: lead

Study Sites (1)

Cheng Ching General Hospital, Chung Kang Branch

Taichung, 40764, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Chou-Chen Chen

CONTACT

ccchen24615237@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)