Colorectal CancerPhase 3NCT05797077
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA
A Phase 3 study testing Colorectal resection surgery., FOLFOX chemotherapy regimen and Capecitabine 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 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… 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 resection surgery., FOLFOX chemotherapy regimen and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 20 Feb 2031
- 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 males and females, aged 18-75 years;
- 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);
- Postoperative ctDNA-positive patients;
- ASA grade < IV and/or ECOG performance status score ≤ 2;
- Participants must have a full understanding of the study and voluntarily sign an informed consent form.
Who cannot join
- Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
- Patients with a history of other malignant tumors.
- Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
- Patients who are allergic to any component of the study.
- Patients who have received other tumor-related investigational drug treatments.
- Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
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- 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.
- Patients with a history of severe mental illness.
- Pregnant or lactating women.
- Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.
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: Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.
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.
- Being tested
- Colorectal resection surgery., FOLFOX chemotherapy regimen, Capecitabine
- Keywords
- Colorectal Cancer, Liver Metastases, ctDNA, maintenance therapy
- Medical subject headings
- Colorectal Neoplasms, Neoplastic Cells, Circulating, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal resection surgery.Procedure or surgery
Colorectal cancer radical resection combined with liver metastasis resection or ablation.
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.
CapecitabineDrug
Also called 5-FU/LV
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.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant chemotherapy combined with maintenance therapy | Experimental | Not described Receives: Procedure: Colorectal resection surgery.; Drug: FOLFOX chemotherapy regimen; Drug: Capecitabine |
| Single adjuvant chemotherapy | Sham comparator | Not described Receives: Procedure: Colorectal resection surgery.; Drug: FOLFOX chemotherapy regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-years 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-years 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-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.
Measured: 3 years after operation.
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.
Measured: 5 years after operation.
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.
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 posted4 Apr 2023
- Study start20 Feb 2023
- Primary completion20 Feb 2029 (estimated)
- Study completion20 Feb 2031 (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
- 346 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
- NCT05797077
- Sponsor's protocol ID
- 1010(PY)2022-10
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2023
- Last updated
- 4 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.
- ClinicalTrials.gov ID
- NCT05797077
- Acronym / sponsor ID
- 1010(PY)2022-10
- Keywords
- Colorectal Cancer, Liver Metastases, ctDNA, maintenance therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Feb 2029 (estimated)
- Study completion
- 20 Feb 2031 (estimated)
- First posted
- 4 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemotherapy combined with maintenance therapy | Experimental | Procedure: Colorectal resection surgery., Drug: FOLFOX chemotherapy regimen, Drug: Capecitabine |
| Single adjuvant chemotherapy | Sham comparator | Procedure: Colorectal resection surgery., Drug: FOLFOX chemotherapy regimen |
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 males and females, aged 18-75 years;
- 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);
- Postoperative ctDNA-positive patients;
- ASA grade < IV and/or ECOG performance status score ≤ 2;
- Participants must have a full understanding of the study and voluntarily sign an informed consent form.
Key exclusion criteria (10 listed)
- Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
- Patients with a history of other malignant tumors.
- Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
- Patients who are allergic to any component of the study.
- Patients who have received other tumor-related investigational drug treatments.
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 resection surgery.Colorectal cancer radical resection combined with liver metastasis resection or ablation. | Procedure or surgery | Adjuvant chemotherapy combined with maintenance therapy, Single adjuvant chemotherapy |
| 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 combined with maintenance therapy, Single adjuvant chemotherapy |
| CapecitabineAlso: 5-FU/LVMaintenance 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. | Drug | Adjuvant chemotherapy combined with maintenance therapy |
Primary outcome
3-years 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-years 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-years overall survival
Time frame: 3 years after operation.
5-years overall survival
Time frame: 5 years after operation.
Complication
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 4 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 resection surgery., FOLFOX chemotherapy regimen and Capecitabine 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 4 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. Some participants in this study may receive a placebo. 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-years 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 4 Apr 2023.