Who is sponsoring NCT05815082?

NCT05815082 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University.

What condition does NCT05815082 study?

NCT05815082 studies Colorectal Cancer, Liver Metastases, Circulating Tumor Cell, Chemotherapy Effect.

Is NCT05815082 still recruiting?

NCT05815082 is currently recruiting now. Last updated 18 April 2023.

Last reviewed 2023-04-18 · How we verify

NCT05815082

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

Recruiting now Phase 3 Last updated 18 April 2023

What this trial tests

Phase 3 trial testing Colorectal cancer resection combined with liver metastasis resection. in Colorectal Cancer in 490 participants. Currently enrolling.

Timeline

20 February 2023

Primary endpoint
20 February 2031

20 February 2033

Quick facts

Lead sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	490
Start date	20 February 2023
Primary completion	20 February 2031
Estimated completion	20 February 2033
Sites	1 location across China

Drugs / interventions tested

Colorectal cancer resection combined with liver metastasis resection.
FOLFOX chemotherapy regimen — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Liver Metastases — all drugs for Liver Metastases →
Circulating Tumor Cell — all drugs for Circulating Tumor Cell →
Chemotherapy Effect — all drugs for Chemotherapy Effect →

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Colorectal Cancer or Liver Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Minimal Residual Disease using a Plasma-Only Circulating Tumor DNA Assay to Predict Recurrence of Metastatic Colorectal Cancer Following Curative Intent Treatment.
Parikh AR, Chee BH, Tsai J, Rich TA, et al · · 2024 · cited 13× · PMID 38695832 · DOI 10.1158/1078-0432.ccr-23-3660
Optimizing Treatment Strategy for Oligometastases/Oligo-Recurrence of Colorectal Cancer.
Yokoi R, Tajima JY, Fukada M, Hayashi H, et al · · 2023 · cited 10× · PMID 38201569 · DOI 10.3390/cancers16010142
Clinical utility and future perspectives of liquid biopsy in colorectal cancer.
Patelli G, Lazzari L, Crisafulli G, Sartore-Bianchi A, et al · · 2025 · cited 7× · PMID 40275061 · DOI 10.1038/s43856-025-00852-4
The Method of Minimal Residual Disease Detection With Circulating Tumor DNA and Its Clinical Applications in Colorectal Cancer.
Liu M, Mu T, Gu J, Xu M, et al · · 2025 · cited 2× · PMID 40033897 · DOI 10.1002/cnr2.70167

Verify or expand the search:

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other Sixth Affiliated Hospital, Sun Yat-sen University trials

Trials by the same sponsor.

NCT07538284 — MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) · Phase 2, PHASE3 · not yet recruiting
NCT07176182 — Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression · Phase 2 · not yet recruiting
NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
NCT07344428 — Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial · NA · not yet recruiting
NCT07328958 — Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic A · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05815082 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
Last refreshed: 18 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05815082.

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