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RecruitingNCT05062317Updated Jul 14, 2026

ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

A Phase 2 interventional study of Leucovorin and 5-FLUOROURACIL in Liver Metastases, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2022; still recruiting 4 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.

Read the detailed description

Primary Objective:

  • To assess 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy

Secondary Objectives:

  • To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients
  • To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients
  • To evaluate the proportion of ctDNA-negative at 1-year post-resection
  • To compare survival of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls
  • To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement
  • To delineate the pattern of disease recurrence
  • To assess ctDNA sensitivity and specificity for predicting disease recurrence
  • To evaluate MDASI-GI during the course of postoperative therapy
  • To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection
  • To evaluate surgery-related adverse events occurring up to 90 days after surgery, and chemo-related adverse events occurring up to 30 days after the last dose of chemotherapy

Outcome Measures:

Primary:

  • Recurrence-free survival at 1-year post-hepatectomy among ctDNA-negative patients

Secondary:

  • Recurrence-free survival at 1-year post-hepatectomy among ctDNA-positive patients
  • Overall survival (OS) among ctDNA-negative and ctDNA-positive patients
  • ctDNA-negativity at 1-year post-resection
  • Proportion of patients in each group with chemotherapy regimen change in response to ctDNA dynamics
  • Pattern of disease recurrence (i.e., liver, systemic, salvageable vs. unsalvageable)
  • ctDNA sensitivity/specificity for recurrent disease overall by timepoint
  • MDASI-GI at clinic visits during course of postoperative therapy
  • Tumor radiologic, histologic, and molecular profiling and correlative characterization based upon ctDNA detection
  • Adverse events
02

Conditions studied

  • Liver Metastases
03

In context

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX/FOLFIRI +/- bevacizumab or panitumumab/cetuximab) from 07/01/2021 - 12/31/2023
  • Must receive ≥ 4 cycles of preoperative chemotherapy

Exclusion criteria

Exclusion Criteria:

  • Patients with primary colorectal tumor that will remain in situ
  • Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori
  • Unwilling/unable to undergo blood draws for ctDNA, patient or provider-determined
  • Other active malignancies requiring treatment
  • Women who are pregnant
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    ctDNA (Low Risk)

    Will receive less intense chemotherapy, such as capecitabine or 5-fluorouracil.

    Drug: Leucovorin · Drug: Capecitabine

  • Experimental
    ctDNA (High Risk)

    Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX \[5-fluorouracil, leucovorin and oxaliplatin\] or FOLFIRI \[5-fluorouracil, leucovorin and irinotecan\] with or without bevacizumab)

    Drug: Leucovorin · Drug: 5-FLUOROURACIL · Drug: Oxaliplatin · Drug: Irinotecan · Drug: Capecitabine · Drug: Bevacizumab

Interventions

  • DrugLeucovorin

    Given by PO

    Also known as: Citrovorum, Wellcovorin®

  • Drug5-FLUOROURACIL

    Given by IV

  • DrugOxaliplatin

    Given by PO

    Also known as: Eloxatin

  • DrugIrinotecan

    Given by IV

  • DrugCapecitabine

    Given by IV

    Also known as: Xeloda

  • DrugBevacizumab

    Given by IV

    Also known as: Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

06

What researchers measure

Primary outcomes

  1. To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05062317
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Sep 30, 2021
Start date
Apr 26, 2022
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Jul 14, 2026

Study contacts

Timothy Newhook
Contact
tnewhook@mdanderson.org
(713) 794-1001
Timothy Newhook
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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