RecruitingPhase 2NCT07136077
A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Sponsor
M.D. Anderson Cancer Center
Enrollment
20 participants
Start Date
Sep 18, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have "positive" ctDNA tests for MRD (meaning there is evidence of MRD based on this test).
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a combination of two cancer drugs — fruquintinib (a targeted therapy) and tislelizumab (an immunotherapy) — in people with colorectal cancer who have no visible signs of disease on scans but still show traces of cancer DNA in their blood (called ctDNA), suggesting a high risk of the cancer coming back.
**You may be eligible if...**
- You have confirmed colorectal cancer (microsatellite stable type, MSS)
- You have completed curative treatment for stage II, III, or IV colorectal cancer, including at least 3 months of oxaliplatin-based chemotherapy
- There is no visible cancer on recent imaging
- A blood test (ctDNA assay, such as Signatera) performed at MD Anderson or a certified lab shows cancer DNA in your blood
**You may NOT be eligible if...**
- Your ctDNA test is negative (no cancer DNA detectable)
- You have visible cancer on scans
- Your colorectal cancer has a microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) profile (a different category that responds to other treatments)
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGTislelizumab
Given by IV
DRUGFruquintinib
Give by PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07136077
Related Trials
Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
NCT0548921196 locations
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
NCT072616318 locations
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
NCT048999082 locations
Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
NCT0578692427 locations
Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
NCT072192382 locations