Colorectal CancerPhase 3NCT05815082
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
A Phase 3 study testing Colorectal cancer resection combined with liver metastasis resection. and FOLFOX chemotherapy regimen in people with Colorectal Cancer and Liver Metastases, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastases, Circulating Tumor Cell
- What is being tested?
- Colorectal cancer resection combined with liver metastasis resection. and FOLFOX chemotherapy regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 20 Feb 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Yanxin Luo, PhD,MD, 86-13826190263, luoyx25@mail.sysu.edu.cn
Yaoyi Huang, BS, 86-15986423743, huangyy355@mail2.sysu.edu.cn
About this study
Official title: ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial
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.
- Being tested
- Colorectal cancer resection combined with liver metastasis resection., FOLFOX chemotherapy regimen
- Keywords
- Colorectal Cancer, Liver Metastases, Circulating Tumor DNA
- Medical subject headings
- Colorectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal cancer resection combined with liver metastasis resection.Procedure or surgery
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 regimenDrug
Also called CapeOx chemotherapy regimen
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
| Study group | Role | What they receive |
|---|---|---|
| Watching and waiting group | Experimental | Watch and Wait strategy is one of the treatment strategies of advanced rectal cancer, which recommends no immediate surgery with close surveillance. Receives: Procedure: Colorectal cancer resection combined with liver metastasis resection. |
| Adjuvant chemotherapy group | Active comparator | Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy. Receives: Procedure: Colorectal cancer resection combined with liver metastasis resection.; Drug: FOLFOX chemotherapy regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Measured: 3 years after operation.
5-year progression-free survival
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Measured: 5 years after operation.
Secondary outcomes (3)
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.
Measured: 3 years after operation.
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.
Measured: 5 years after operation.
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).
Measured: 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Feb 2023
- Primary completion20 Feb 2031 (estimated)
- Study completion20 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanxin Luo,MD, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815082
- Sponsor's protocol ID
- 1010(CG)2022-02
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05815082
- Acronym / sponsor ID
- 1010(CG)2022-02
- Keywords
- Colorectal Cancer, Liver Metastases, Circulating Tumor DNA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Feb 2031 (estimated)
- Study completion
- 20 Feb 2033 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Watching and waiting group | Experimental | Procedure: Colorectal cancer resection combined with liver metastasis resection.Watch and Wait strategy is one of the treatment strategies of advanced rectal cancer, which recommends no immediate surgery with close surveillance. |
| Adjuvant chemotherapy group | Active comparator | Procedure: Colorectal cancer resection combined with liver metastasis resection., Drug: FOLFOX chemotherapy regimenChemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Adjuvant chemotherapy group, Watching and waiting group |
| FOLFOX chemotherapy regimenAlso: CapeOx chemotherapy regimenChemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy. | Drug | Adjuvant chemotherapy group |
Primary outcome
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.
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colorectal cancer resection combined with liver metastasis resection. and FOLFOX chemotherapy regimen in people with Colorectal Cancer and Liver Metastases, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression-free survival (time frame: 3 years after operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.