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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorChou-Chen Chen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Non

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Treatment
Group B: Control

Trial outcomes

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]).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chou-Chen Chen

Lead sponsor

Cheng Ching Hospital

Sponsor institution