Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

15. juli 2026 oppdatert av: Chou-Chen Chen

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.

Studieoversikt

Status

Rekruttering

Forhold

Overlevelse, svulst

Studietype

Observasjonsmessig

Registrering (Antatt)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Chou-Chen Chen
E-post: ccchen24615237@gmail.com

Studiesteder

Taiwan
- - Taichung, Taiwan, 40764
    - Rekruttering
    - Cheng Ching General Hospital, Chung Kang Branch
    - Ta kontakt med:
      
      Chou-Chen Chen
      
      E-post: ccchen24615237@gmail.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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:

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Treatment Immunomodulator (APS Injection) plus standard anti-cancer therapies
Control Standard anti-cancer therapies

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Overall survival Tidsramme: From the earliest record until Dec 2030	From the earliest record until Dec 2030

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Disease free survival Tidsramme: From the earliest record until Dec 2030		From the earliest record until Dec 2030
Distant metastasis free survival Tidsramme: From the earliest record until Dec 2030		From the earliest record until Dec 2030
Progress free survival Tidsramme: From the earliest record until Dec 2030		From the earliest record until Dec 2030
Hematological lab data change Tidsramme: Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).		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 Tidsramme: Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).		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 Tidsramme: 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).	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 Tidsramme: 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.	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 Tidsramme: Baseline and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).		Baseline and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chou-Chen Chen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juli 2026

Primær fullføring (Antatt)

31. desember 2030

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

6. juli 2026

Først innsendt som oppfylte QC-kriteriene

12. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene