ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815082
• Other study ID #: 1010(CG)2022-02
• Status: Recruiting
• Phase: Phase 3
• Start date: February 20, 2023
• Est. completion date: February 20, 2033

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: February 20, 2033
• Est. primary completion date: February 20, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Circulating Tumor Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplastic Cells, Circulating

Intervention

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.

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-year 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-year 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-year 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	3-year 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	Complications	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).	5 years.