Liver MetastasesPhase 2NCT05062317
ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
A Phase 2 study testing Leucovorin, 5-FLUOROURACIL and Oxaliplatin in people with Liver Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases
- What is being tested?
- Leucovorin, 5-FLUOROURACIL and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Timothy Newhook, 713-794-1001, tnewhook@mdanderson.org
Timothy Newhook
About this study
Official title: Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
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
- Conditions
- Liver Metastases
- Being tested
- Leucovorin, 5-FLUOROURACIL, Oxaliplatin, Irinotecan, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucovorinDrug
Also called Citrovorum, Wellcovorin®
Given by PO
5-FLUOROURACILDrug
Given by IV
OxaliplatinDrug
Also called Eloxatin
Given by PO
IrinotecanDrug
Given by IV
CapecitabineDrug
Also called Xeloda
Given by IV
BevacizumabDrug
Also called Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| ctDNA (Low Risk) | Experimental | Will receive less intense chemotherapy, such as capecitabine or 5-fluorouracil. Receives: Drug: Leucovorin; Drug: Capecitabine |
| ctDNA (High Risk) | Experimental | 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) Receives: Drug: Leucovorin; Drug: 5-FLUOROURACIL; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Capecitabine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start26 Apr 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Newhook, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062317
- Sponsor's protocol ID
- 2021-0584
- Other IDs
- NCI-2021-10706
- Status last verified
- Jul 2026
- First submitted
- 21 Sep 2021
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT05062317
- Acronym / sponsor ID
- 2021-0584
- Conditions
- Liver Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA (Low Risk) | Experimental | Drug: Leucovorin, Drug: CapecitabineWill receive less intense chemotherapy, such as capecitabine or 5-fluorouracil. |
| ctDNA (High Risk) | Experimental | Drug: Leucovorin, Drug: 5-FLUOROURACIL, Drug: Oxaliplatin, Drug: Irinotecan, Drug: Capecitabine, Drug: BevacizumabWill 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeucovorinAlso: Citrovorum, Wellcovorin®Given by PO | Drug | ctDNA (High Risk), ctDNA (Low Risk) |
| 5-FLUOROURACILGiven by IV | Drug | ctDNA (High Risk) |
| OxaliplatinAlso: EloxatinGiven by PO | Drug | ctDNA (High Risk) |
| IrinotecanGiven by IV | Drug | ctDNA (High Risk) |
| CapecitabineAlso: XelodaGiven by IV | Drug | ctDNA (High Risk), ctDNA (Low Risk) |
| BevacizumabAlso: Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGFGiven by IV | Drug | ctDNA (High Risk) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- M D Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Newhook principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leucovorin, 5-FLUOROURACIL and Oxaliplatin in people with Liver Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Newhook ((713) 794-1001, tnewhook@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.