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Personalized treatment for high-risk colon cancer using liquid biopsy

A Precision Medicine Trial Leveraging Blood-Based Tumor Genomics to Optimize Treatment in Operable Stage III and High-Risk Stage II Colon Cancer Patients

Phase 3 Interventional IFOM ETS - The AIRC Institute of Molecular Oncology · NCT06490536

This study is testing whether personalized treatment based on blood tests can help high-risk colon cancer patients do better after surgery compared to standard chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorIFOM ETS - The AIRC Institute of Molecular Oncology Academic / other
Drugs / interventionsnivolumab, ipilimumab, trastuzumab, pertuzumab, panitumumab, chemotherapy, Immunotherapy
Locations26 sites (Berlin and 25 other locations)
Trial IDNCT06490536 on ClinicalTrials.gov

What this trial studies

The Sagittarius Trial aims to improve outcomes for high-risk stage II and stage III colon cancer patients by utilizing liquid biopsy (LB) to detect residual cancer DNA after surgery. Patients will be randomized into either standard chemotherapy or personalized treatment based on their LB results, allowing for tailored therapies that may reduce unnecessary toxicity. The study will also evaluate recurrence times, side effects, quality of life, and the accuracy of LB in monitoring treatment response. This phase 3 trial seeks to establish the efficacy of targeted therapies compared to conventional approaches.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with operable stage III or high-risk stage II colon cancer.

Not a fit: Patients with a history of another neoplastic disease or those who have had recent colonoscopy complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better treatment outcomes and improved quality of life for patients with high-risk colon cancer.

How similar studies have performed: Other studies have shown promising results using liquid biopsy for monitoring treatment response in colorectal cancer, indicating that this approach has potential based on prior evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* SAGITTARIUS trial written informed consent.
* Age ≥ 18 years.
* Histologically confirmed diagnosis of operable stage III and High-Risk stage II CC located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.
* Availability of the original FFPE tumor tissue.
* ECOG performance status 0-1.
* Normal organ functions (as defined in section 9.3).
* Women with childbearing potential (WOCBP) should complete a pregnancy test and be willing to use highly effective contraceptive methods.

Exclusion Criteria:

* History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
* Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).
* Current or recent treatment with another investigational drug or participation in another investigational study.
* Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
* Inadequate contraception (male or female patients) if of childbearing or procreational potential.
* Clinically relevant cardiovascular disease.
* Acute or subacute intestinal occlusion or history of inflammatory bowel disease or any other autoimmune disease.
* Pre-existing neuropathy \> grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
* Has a known history of Human Immunodeficiency Virus (HIV).
* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus infection.
* Has a known history of active TB (Bacillus Tuberculosis).
* Has a medical condition that contraindicate the use of the investigational medicinal product (IMP) according to product indications.
* Prior neoadjuvant treatment administered before surgery.

Where this trial is running

Berlin and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colon Cancer Stage IIColon Cancer Stage III
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.