Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal CancerPhase 2NCT05720559
Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection
A Phase 2 study testing Oxaliplatin, S1 and Cetuximab in people with Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal Cancer, run by Liaoning Cancer Hospital & Institute.
Trial summary
In this study, the Quintuple method was applied for early intervention of prehepatic CTC-positive bowel cancer patients without dominant liver metastasis, aiming to explore the blocking effect of the Quintuple method on the metachronous liver metastases of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal Cancer
- What is being tested?
- Oxaliplatin, S1 and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-80 at the time of signing the informed consent;
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
- Radical surgery has been performed;
- Imaging examination showed no liver metastasis;
- Prehepatic CTC number ≥1;
- The ECOG performance status is 0-1.
- No combination of other life-threatening diseases;
- Willingness and ability to follow scheduled visits, treatment plans, laboratory tests and other research procedures.
Who cannot join
- Patients with non-primary colorectal cancer;
- Patients with liver metastasis or other organ metastasis;
- Patients without prehepatic CTC or whose prehepatic CTC were negative;
- People who are severely allergic to one or more of the drugs required in the test;
- Patients with severe underlying diseases of respiratory, circulatory, urinary and hematopoietic systems.
Trial locations and contacts
No sites are listed yet.
About this study
In this study, the Quintuple method was applied for early intervention of prehepatic CTC-positive bowel cancer patients without dominant liver metastasis, aiming to explore the blocking effect of the Quintuple method on the metachronous liver metastases of colorectal cancer. A one-arm randomized clinical trial was conducted, and the patients were grouped according to their treatment methods. The patients with metachronous liver metastases were used as the end point of the experiment to evaluate the blocking effect of quintuple therapy.
Read the detailed description
Patients diagnosed with colorectal cancer, clinical stage I to III, underwent radical surgery, and prehepatic CTC≥1 were enrolled. Patients were randomly divided into Conventional treatment group and Quintuple method treatment group. Patients in the Conventional treatment group received conventional treatment according to the NCCN Guidelines for Colorectal Cancer 2023 edition. For patients in the Quintuple method treatment group, Quintuple method intervention was adopted, that is, combined with SOX regimen chemotherapy, low-dose cetuximab targeted therapy and three-drug regimen of folic acid, vitamin A and metronidazole. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 * patient's body surface area, d2-d15 was taken orally by Digio, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 * patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. The above regimen lasted for 6 to 8 sessions, and enrolled patients were reviewed every 3 months for colorectal cancer-related tumor markers, including MRI and CT imaging. The primary endpoint was radiographically confirmed metachronous liver metastases, and the secondary endpoint was death, observed for 3 years.
- Being tested
- Oxaliplatin, S1, Cetuximab, Metronidazole, Vitamin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Oxaliplatin via intravenous drip on d1 at a dose of 130mg/m2 × patient 's body surface area
S1Drug
Orally on d2-d15 at 20 mg three times daily
CetuximabDrug
Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.
MetronidazoleDrug
Metronidazole 0.4g/time, qd
Vitamin ADrug
Vitamin A 25,000 units/time, qd
Folic acidDrug
Folic acid 0.4 mg/time, qd
CapecitabineDrug
Capecitabine via orally on d2-d15 two times daily at a dose of 1000mg/m2 × patient 's body surface area.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Experimental | Conventional treatment was performed according to the NCCN Guidelines for Colorectal Cancer 2023 Edition Receives: Drug: Oxaliplatin; Drug: Capecitabine |
| Quintuple method treatment group | Experimental | SOX regimen chemotherapy, low dose cetuximab targeted therapy, and folic acid, vitamin A, metronidazole three-drug regimen were combined. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 * patient's body surface area, d2-d15 was taken orally by S1, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 * patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. These regimens last for 6 to 8 sessions. Receives: Drug: Oxaliplatin; Drug: S1; Drug: Cetuximab; Drug: Metronidazole; Drug: Vitamin A; Drug: Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metachronous liver metastasis rate
The Metachronous liver metastasis rate is the proportion of CTC-positive patients with metachronous liver metastases after conventional therapy or quintuple method intervention.
Measured: Up to approximately 3 years
Overall Survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Zhongguo, Doctor, Study director, Liaoning Tumor Hospital & Institute Shenyang, Liaoning, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720559
- Sponsor's protocol ID
- 20230201zzg
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection
- ClinicalTrials.gov ID
- NCT05720559
- Acronym / sponsor ID
- 20230201zzg
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 9 Feb 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.
In this study, the Quintuple method was applied for early intervention of prehepatic CTC-positive bowel cancer patients without dominant liver metastasis, aiming to explore the blocking effect of the Quintuple method on the metachronous liver metastases of colorectal cancer. A one-arm randomized clinical trial was conducted, and the patients were grouped according to their treatment methods. The patients with metachronous liver metastases were used as the end point of the experiment to evaluate the blocking effect of quintuple therapy.
Detailed description
Patients diagnosed with colorectal cancer, clinical stage I to III, underwent radical surgery, and prehepatic CTC≥1 were enrolled. Patients were randomly divided into Conventional treatment group and Quintuple method treatment group. Patients in the Conventional treatment group received conventional treatment according to the NCCN Guidelines for Colorectal Cancer 2023 edition. For patients in the Quintuple method treatment group, Quintuple method intervention was adopted, that is, combined with SOX regimen chemotherapy, low-dose cetuximab targeted therapy and three-drug regimen of folic acid, vitamin A and metronidazole. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 * patient's body surface area, d2-d15 was taken orally by Digio, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 * patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. The above regimen lasted for 6 to 8 sessions, and enrolled patients were reviewed every 3 months for colorectal cancer-related tumor markers, including MRI and CT imaging. The primary endpoint was radiographically confirmed metachronous liver metastases, and the secondary endpoint was death, observed for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Experimental | Drug: Oxaliplatin, Drug: CapecitabineConventional treatment was performed according to the NCCN Guidelines for Colorectal Cancer 2023 Edition |
| Quintuple method treatment group | Experimental | Drug: Oxaliplatin, Drug: S1, Drug: Cetuximab, Drug: Metronidazole, Drug: Vitamin A, Drug: Folic acidSOX regimen chemotherapy, low dose cetuximab targeted therapy, and folic acid, vitamin A, metronidazole three-drug regimen were combined. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 * patient's body surface area, d2-d15 was taken orally by S1, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 * patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. These regimens last for 6 to 8 sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 18-80 at the time of signing the informed consent;
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
- Radical surgery has been performed;
- Imaging examination showed no liver metastasis;
- Prehepatic CTC number ≥1;
Key exclusion criteria (5 listed)
- Patients with non-primary colorectal cancer;
- Patients with liver metastasis or other organ metastasis;
- Patients without prehepatic CTC or whose prehepatic CTC were negative;
- People who are severely allergic to one or more of the drugs required in the test;
- Patients with severe underlying diseases of respiratory, circulatory, urinary and hematopoietic systems.
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 |
|---|---|---|
| OxaliplatinOxaliplatin via intravenous drip on d1 at a dose of 130mg/m2 × patient 's body surface area | Drug | Conventional treatment group, Quintuple method treatment group |
| S1Orally on d2-d15 at 20 mg three times daily | Drug | Quintuple method treatment group |
| CetuximabCetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area. | Drug | Quintuple method treatment group |
| MetronidazoleMetronidazole 0.4g/time, qd | Drug | Quintuple method treatment group |
| Vitamin AVitamin A 25,000 units/time, qd | Drug | Quintuple method treatment group |
| Folic acidFolic acid 0.4 mg/time, qd | Drug | Quintuple method treatment group |
| CapecitabineCapecitabine via orally on d2-d15 two times daily at a dose of 1000mg/m2 × patient 's body surface area. | Drug | Conventional treatment group |
Primary outcome
Metachronous liver metastasis rate
Time frame: Up to approximately 3 years
The Metachronous liver metastasis rate is the proportion of CTC-positive patients with metachronous liver metastases after conventional therapy or quintuple method intervention.
Overall Survival (OS)
Time frame: Up to approximately 3 years
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Zhang Zhongguo, Doctor study director
Liaoning Tumor Hospital & Institute Shenyang, Liaoning, China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, S1 and Cetuximab in people with Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal Cancer, run by Liaoning Cancer Hospital & Institute.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Zhongguo, Doctor (15840217908, Zhangzhongguoln@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metachronous liver metastasis rate (time frame: Up to approximately 3 years). 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 9 Feb 2023.