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Recruiting NCT05815082

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

Phase III Interventional Colorectal Cancer Liver Metastases Circulating Tumor Cell Chemotherapy Effect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colorectal cancer resection combined with liver metastasis resection., FOLFOX chemotherapy regimen.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Liver Metastases, Circulating Tumor Cell, Chemotherapy Effect. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.

Interventions

  • Procedure Colorectal cancer resection combined with liver metastasis resection.
    The preferred surgical approach is resection of the corresponding colon segment with regional lymph node dissection. If conditions permit, synchronous resection of the primary lesion and liver metastases of colorectal cancer can be performed to achieve curative resection.
  • Drug FOLFOX chemotherapy regimen
    Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

Primary outcome measures

  • 3-year progression-free survival [Time frame: 3 years after operation.]
  • 5-year progression-free survival [Time frame: 5 years after operation.]
Secondary outcome measures (3)
  • 3-year overall survival [Time frame: 3 years after operation.]
  • 3-year overall survival [Time frame: 5 years after operation.]
  • Complications [Time frame: 5 years.]

Eligibility criteria

Inclusion criteria

  • Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
  • 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);
  • Patients with negative ctDNA after surgery;
  • ASA grade <IV and/or ECOG performance status score ≤ 2;
  • Have sufficient understanding of the study and voluntarily sign an informed consent form.

Exclusion criteria

  • Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
  • Patients with a history of other malignancies;
  • Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
  • Patients who are allergic to any component in the study;
  • Patients who have received other tumor-related investigational drug therapy;
  • Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
  • 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;
  • Patients with a history of severe mental illness;
  • Pregnant or lactating women;
  • Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Sixth Affiliate Hospital of Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT05815082 · 1010(CG)2022-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗