Comparing chemotherapy and observation for liver metastasis in colorectal cancer

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial

This study is testing if some patients with liver metastasis from colorectal cancer can safely skip chemotherapy after surgery and just be monitored instead.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 490 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05815082 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate whether a 'watching and waiting' approach is as effective as adjuvant chemotherapy for patients with resectable colorectal cancer liver metastases who test negative for circulating tumor DNA (ctDNA) after surgery. Participants will be randomly assigned to either receive the FOLFOX chemotherapy regimen or to be monitored without immediate treatment. The primary outcome measured will be the 3-year progression-free survival rate between the two groups. This study seeks to determine if avoiding chemotherapy is a viable option for certain patients post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with resectable colorectal cancer liver metastases who have achieved R0 resection and have negative ctDNA results post-surgery.

Not a fit: Patients with distant metastases, severe underlying health conditions, or those who have received other investigational therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less aggressive treatment option for patients with colorectal cancer liver metastases, potentially reducing the side effects associated with chemotherapy.

How similar studies have performed: While there have been studies exploring ctDNA in cancer treatment, this specific approach comparing chemotherapy to observation in this patient population is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
2. Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
3. Patients with negative ctDNA after surgery;
4. ASA grade \<IV and/or ECOG performance status score ≤ 2;
5. Have sufficient understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
2. Patients with a history of other malignancies;
3. Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
4. Patients who are allergic to any component in the study;
5. Patients who have received other tumor-related investigational drug therapy;
6. Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
7. Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests;
8. Patients with a history of severe mental illness;
9. Pregnant or lactating women;
10. Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.

Where this trial is running

Guangzhou, Guangdong

• The Sixth Affiliate Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)

Conditions: Colorectal Cancer, Liver Metastases, Circulating Tumor Cell, Chemotherapy Effect, Circulating Tumor DNA