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

NCT05062317 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2021-0584
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  through study completion, an average of 1 year

Study Arms (2)

ctDNA (Low Risk)

EXPERIMENTAL

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

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)

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

Interventions

Leucovorin DRUG

Given by PO

Also known as: Citrovorum, Wellcovorin®

ctDNA (High Risk); ctDNA (Low Risk)

5-FLUOROURACIL DRUG

Given by IV

ctDNA (High Risk)

Oxaliplatin DRUG

Given by PO

Also known as: Eloxatin

ctDNA (High Risk)

Irinotecan DRUG

Given by IV

ctDNA (High Risk)

Capecitabine DRUG

Given by IV

Also known as: Xeloda

ctDNA (High Risk); ctDNA (Low Risk)

Bevacizumab DRUG

Given by IV

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

ctDNA (High Risk)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center website

MeSH Terms

Interventions

Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Capecitabine; Bevacizumab

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Timothy Newhook

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Newhook

CONTACT

(713) 794-1001; tnewhook@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: April 26, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)