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

Liver Metastases Clinical Trial

Official title:

Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062317
• Other study ID #: 2021-0584
• Status: Recruiting
• Phase: Phase 2
• Start date: April 26, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Timothy Newhook
• Phone: (713) 794-1001
• Email: tnewhook[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center website