Clinical trial NCT05815082: ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
Official title: ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer
Liver Metastases
Circulating Tumor Cell
Chemotherapy Effect
Keywords: Colorectal Cancer
Liver Metastases
Circulating Tumor DNA
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: 3-year progression-free survival
timeFrame: 3 years after operation.
measure: 5-year progression-free survival
timeFrame: 5 years after operation.
Secondary outcomes:
measure: 3-year overall survival
timeFrame: 3 years after operation.
measure: 3-year overall survival
timeFrame: 5 years after operation.
measure: Complications
timeFrame: 5 years.
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Sixth Affiliate Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: