Colorectal Cancer Liver MetastasisPhase 2NCT06590259
A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM
A Phase 2 study testing Multi-mode tumor treatment system and Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab in people with Colorectal Cancer Liver Metastasis, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Liver Metastasis
- What is being tested?
- Multi-mode tumor treatment system and Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to Dec 2027
- Phase
- Phase 2
- 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
- Age 18-75 years, gender not specified;
- Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
- In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
- Failure of first-line treatment, with disease progression or new liver metastases;
- No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
- For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month;
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- Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10^9/L, platelets ≥ 100 ×10^9/L;
- ECOG PS ≤ 2;
- Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.
Who cannot join
- Liver function Child-Pugh class C;
- Expected survival < 3 months;
- Major organ insufficiency or failure;
- Active infection;
- Irreversible coagulation disorders;
- Refractory massive ascites, pleural effusion or cachexia;
- Unable to cooperate with treatment;
- Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chief physician of Medical Oncology contact
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai
Chief of Medical Oncology
About this study
Official title: A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)
The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.
Read the detailed description
This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis. The study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. All patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including PD-1 inhibitor.
This study will provide preliminary data on the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis, which could lead to larger randomized trials.
- Conditions
- Colorectal Cancer Liver Metastasis
- Being tested
- Multi-mode tumor treatment system, Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-mode tumor treatment systemDevice
Also called MTT-P1
All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. Complete ablation of intrahepatic lesions is achieved to realize an intrahepatic no-evidence-of-disease (NED) state. For lesions that could not be ablated in a single session, two treatments are performed to achieve NED within the liver.
Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximabDrug
Also called Systemic therapy including PD-1 inhibitor
Systemic therapy including PD-1 inhibitor starts on the 7th day after ablation (sintilimab 200 mg IV D1 + mFOLFOX6 or FOLFIRI + bevacizumab or cetuximab (determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.）
| Study group | Role | What they receive |
|---|---|---|
| Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor | Experimental | Multi-mode ablation therapy +systemic therapy including PD-1 inhibitor (sintilimab 200 mg IV D1+ mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab（determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.) Receives: Device: Multi-mode tumor treatment system; Drug: Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression free survival (PFS) is defined as the time from the start of treatment until the criteria for documented progression of disease (or until death due to any cause) are met, whichever comes first according to RECIST 1.1.
Measured: max 24 months
Secondary outcomes (5)
Local Progression Free Survival (LPFS)
Local progression-free survival (LPFS) is defined as the time from the start of treatment until documented local progression of the lesion(s) under assessment, or until death from any cause, whichever comes first according to RECIST 1.1.
Measured: max 24 months
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment according to RECIST 1.1.
Measured: max 24 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from the start of treatment until death from any cause.
Measured: max 24 months
Rate of adverse events
The rate of adverse events will be calculated as the number of participants experiencing any adverse event divided by the total number of participants enrolled in the study.
Measured: max 24 months
Immune indicator analysis
Immune indicator analysis will be conducted to evaluate the immune status and response of participants to the intervention. This will include the assessment of various immune cell populations and markers, such as:
- CD4+ and CD8+ T lymphocyte counts and ratios.
- Natural Killer (NK) cell activity and counts.
- B cell counts and subsets.
- Dendritic cell (DC) counts and functionality.
- Monocyte counts and subsets.
- Neutrophil, eosinophil and basophil counts.
- Myeloid-derived suppressor cell (MDSC) counts. The analysis will utilize flow cytometry to quantify these immune indicators from blood samples collected at specified time points before, during and after the intervention.
Measured: max 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Mar 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Liver MetastasisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Zan, Shanghai 6th People's Hospital
- Investigators
- Chief physician of Medical Oncology, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590259
- Sponsor's protocol ID
- 20231124
- Status last verified
- Sep 2024
- First submitted
- 9 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)
- ClinicalTrials.gov ID
- NCT06590259
- Acronym / sponsor ID
- 20231124
- Conditions
- Colorectal Cancer Liver Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (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 study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.
Detailed description
This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis. The study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. All patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including PD-1 inhibitor.
This study will provide preliminary data on the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis, which could lead to larger randomized trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor | Experimental | Device: Multi-mode tumor treatment system, Drug: Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximabMulti-mode ablation therapy +systemic therapy including PD-1 inhibitor (sintilimab 200 mg IV D1+ mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab（determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years, gender not specified;
- Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
- In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
- Failure of first-line treatment, with disease progression or new liver metastases;
- No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
Key exclusion criteria (8 listed)
- Liver function Child-Pugh class C;
- Expected survival < 3 months;
- Major organ insufficiency or failure;
- Active infection;
- Irreversible coagulation disorders;
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 |
|---|---|---|
| Multi-mode tumor treatment systemAlso: MTT-P1All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. Complete ablation of intrahepatic lesions is achieved to realize an intrahepatic no-evidence-of-disease (NED) state. For lesions that could not be ablated in a single session, two treatments are performed to achieve NED within the liver. | Device | Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor |
| Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximabAlso: Systemic therapy including PD-1 inhibitorSystemic therapy including PD-1 inhibitor starts on the 7th day after ablation (sintilimab 200 mg IV D1 + mFOLFOX6 or FOLFIRI + bevacizumab or cetuximab (determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.） | Drug | Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor |
Primary outcome
Progression Free Survival (PFS)
Time frame: max 24 months
Progression free survival (PFS) is defined as the time from the start of treatment until the criteria for documented progression of disease (or until death due to any cause) are met, whichever comes first according to RECIST 1.1.
5 secondary outcomes
Local Progression Free Survival (LPFS)
Time frame: max 24 months
Objective Response Rate (ORR)
Time frame: max 24 months
Overall Survival (OS)
Time frame: max 24 months
Rate of adverse events
Time frame: max 24 months
Immune indicator analysis
Time frame: max 24 months
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 19 Sep 2024.
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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.
Chief physician of Medical Oncology contact
Chief physician of Medical Oncology principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multi-mode tumor treatment system and Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab in people with Colorectal Cancer Liver Metastasis, run by Shanghai 6th People's Hospital 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 9 inclusion and 8 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 19 Sep 2024. 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 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?
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?
Contact Chief physician of Medical Oncology (13816067266, ssshenzan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: max 24 months). 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 19 Sep 2024.