Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Colorectal Cancer Clinical Trial

Official title:

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797077
• Other study ID #: 1010(PY)2022-10
• Status: Recruiting
• Phase: Phase 3
• Start date: February 20, 2023
• Est. completion date: February 20, 2031

Study information

• Verified date: April 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 346
• Est. completion date: February 20, 2031
• Est. primary completion date: February 20, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Both males and females, aged 18-75 years;

2. Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect);

3. Postoperative ctDNA-positive patients;

4. ASA grade < IV and/or ECOG performance status score = 2;

5. Participants must have a full understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.

2. Patients with a history of other malignant tumors.

3. Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.

4. Patients who are allergic to any component of the study.

5. Patients who have received other tumor-related investigational drug treatments.

6. Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.

7. Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities.

8. Patients with a history of severe mental illness.

9. Pregnant or lactating women.

10. Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

Related Conditions & MeSH terms

• Cancer, Therapy-Related
• Circulating Tumor Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Neoplastic Cells, Circulating

Intervention

Procedure:
• Colorectal resection surgery.
Colorectal cancer radical resection combined with liver metastasis resection or ablation.

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.
• Capecitabine
Maintenance therapy is recommended to be continued with low-toxicity drugs such as 5-FU/LV or capecitabine, and may be combined with targeted therapy. Treatment should be discontinued once ctDNA testing is negative.

Locations

Country	Name	City	State
China	The Sixth Affiliate Hospital of Sun Yat-Sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-years Progression Free Survival	PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.	3 years after operation.
Primary	5-years Progression Free Survival	PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.	5 years after operation.
Secondary	3-years overall survival	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 years after operation.
Secondary	5-years overall survival	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.	5 years after operation.
Secondary	Complication	he complications of adjuvant therapy usually refer to the adverse events that occur during or after treatment, including but not limited to chemotherapy-related adverse reactions, radiation therapy-related adverse reactions, and postoperative complications. Specifically, chemotherapy-related adverse reactions may include nausea, vomiting, diarrhea, anemia, and infections; radiation therapy-related adverse reactions may include skin inflammation, nausea, vomiting, diarrhea, fatigue, and dry mouth; postoperative complications may include bleeding, infection, intestinal obstruction, and poor wound healing. Researchers typically record the types, severity, and impact of these complications on treatment to evaluate the safety and tolerability of adjuvant therapy.	5 years.