Recruiting
Phase 2

CtDNA-Directed Chemotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05062317

Conditions

Liver Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Leucovorin

5-FLUOROURACIL

Oxaliplatin

Irinotecan

Capecitabine

Study Details

Brief 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.

Conditions

Liver Metastases

Study ID

NCT05062317

Start date

Apr 26, 2022

Status verified date

Jul, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ctDNA (Low Risk)

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

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)

Interventions

Leucovorin

Given by PO

5-FLUOROURACIL

Given by IV

Oxaliplatin

Given by PO

Irinotecan

Given by IV

Capecitabine

Given by IV

Bevacizumab

Given by IV

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 ]

Central Contacts and Locations

Central contacts

Timothy Newhook

(713) 794-1001tnewhook@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Timothy Newhook

713-794-1001tnewhook@mdanderson.org

Principal Investigator:

Timothy Newhook

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-14.