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NCT Number: NCT05815082

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

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.

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Key information

Conditions

Colorectal Cancer Chemotherapy Effect Circulating Tumor Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Metastases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colorectal cancer resection combined with liver metastasis resection.

Procedure

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.

FOLFOX chemotherapy regimen

Drug

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

Other names: CapeOx chemotherapy regimen

Primary outcomes

  1. 3-year progression-free survival

    Time frame: 3 years after operation.

    PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.

  2. 5-year progression-free survival

    Time frame: 5 years after operation.

    PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.

Secondary outcomes

  1. 3-year overall survival

    Time frame: 3 years after operation.

    Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.

  2. 3-year overall survival

    Time frame: 5 years after operation.

    Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.

  3. Complications

    Time frame: 5 years.

    When evaluating the safety and tolerability of adjuvant therapy, researchers typically assess adverse events (AEs) based on their incidence and severity, and then grade them according to the NCI CTCAE version 5.0. NCI CTCAE 5.0 categorizes AEs into 5 grades based on severity, including grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death).

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2031
Study completion
2033
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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