Colorectal Neoplasms MalignantPhase 3NCT06208371
Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM
A Phase 3 study testing Surgical resection and/or ablation therapy and/or SBRT and Palliative Chemotherapy in people with Colorectal Neoplasms Malignant, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate the effectiveness of localized interventions in improving the 5-year survival rate for colorectal cancer patients with ≥10 liver metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms Malignant
- What is being tested?
- Surgical resection and/or ablation therapy and/or SBRT and Palliative Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 30 Jun 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Baseline imaging (CT, MRI, or PET/CT as necessary) or pathological confirmation of liver metastasis, with no extrahepatic metastasis (consideration for inclusion may be given to lesions with a diameter less than 10mm in the lungs or lymph nodes if metastasis is difficult to confirm or is suspected).
- Disease control (PR or SD) achieved after a minimum of 8 cycles of systemic chemotherapy.
- Evaluation by a centralized liver surgeon expert group to confirm presence of ≥10 liver metastases, which can be managed through surgery and/or ablation and/or SBRT to achieve NED. Non-resectability is defined as one or more of the following: ① Unable to undergo R0 resection; ② Predicted insufficient remaining liver volume after resection; ③ After resection, none of the three hepatic veins can be preserved, and the preservation of residual liver inflow and outflow and bile ducts cannot be guaranteed, and adjacent two liver segments cannot be preserved.
- Curative surgery possible for the primary colorectal lesion.
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- Normal hematological, hepatic, and renal functions at baseline.
- Child-Pugh grade A liver function.
- ECOG performance status 0-1.
- Tolerability to undergo further surgery and chemotherapy.
- Life expectancy > 3 months.
- Signed written informed consent.
- Willing and able to undergo follow-up until death, study completion, or study termination.
Who cannot join
- Definite presence of extrahepatic metastasis and/or primary tumor not amenable to curative surgical resection.
- Severe arterial embolism or ascites.
- Bleeding tendencies or coagulation disorders.
- Hypertensive crisis or hypertensive encephalopathy.
- Severe uncontrollable systemic complications such as infection or diabetes.
- Clinically severe cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension despite appropriate medical treatment, unstable angina, congestive heart failure (NYHA 2-4), and arrhythmias requiring medication.
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- History or physical examination indicating central nervous system diseases (such as primary brain tumor, uncontrollable epilepsy, any brain metastasis, or history of stroke).
- Diagnosis of other malignant tumors within the past 5 years (excluding basal cell carcinoma after radical surgery and/or cervical carcinoma in situ).
- Pregnant or lactating women.
- Women of childbearing potential not using or refusing to use effective non-hormonal contraceptive methods (intrauterine devices, combined barrier contraceptive methods with spermicidal gel, or sterilization) or men with reproductive potential.
- Inability or unwillingness to comply with the study protocol.
- Any other diseases, metastatic lesions causing functional impairment, or suspicious findings in the physical examination indicating possible contraindications for the use of investigational drugs or placing the patient at a high risk of treatment-related complications.
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
Sun Yat-sen Cancer Center
Guangzhou, Guangdong, 510060
Yuhong Li, PhD, 87342487 ext. 020, liyh@sysucc.org.cn
About this study
Official title: The DECIDE-CRLM-10 Randomized Controlled Study: Comparison of Chemotherapy Combined With Localized Treatment for Liver Metastases Versus Palliative Chemotherapy Alone in Colorectal Patients With 10 or More Liver Metastases
The goal of this clinical trial is to investigate the effectiveness of localized interventions in improving the 5-year survival rate for colorectal cancer patients with ≥10 liver metastases. We aim to answer the following question:
Can localized interventions, including surgery and/or ablation and/or stereotactic body radiotherapy (SBRT), enhance the 5-year survival rate compared to palliative chemotherapy alone in patients with ≥10 colorectal liver metastases (CRLM)?
Participants in this study, who have achieved disease control through chemotherapy, will undergo either localized interventions (surgery and/or ablation and/or SBRT) or receive palliative chemotherapy alone. Researchers will compare the survival outcomes between these groups to determine the potential benefits of localized interventions for patients with ≥10 CRLM.
Read the detailed description
Colorectal cancer is one of the most common malignant tumors, ranking second globally in cancer-related mortality. In recent years, both the incidence and mortality rates of colorectal cancer in China have shown a gradual upward trend. According to literature reports, 20% of colorectal cancer patients are diagnosed with liver metastases (CRLM), and as the disease progresses, up to 50% of patients may develop liver metastases, a primary cause of treatment failure for these patients. Surgical resection of liver metastases remains the main curative treatment for colorectal cancer patients, with 5-year and 10-year survival rates reaching 33% and 23%, respectively. However, only 15%-20% of patients are eligible for liver surgery. Advances in targeted drugs and systemic chemotherapy in recent years have improved the response rate of colorectal cancer patients with liver metastases. Several clinical studies confirm that neoadjuvant chemotherapy can reduce the size and stage of liver metastases, allowing initially unresectable patients the opportunity for surgical intervention. Simultaneously, various local treatment modalities for colorectal liver metastases, including surgery, ablation therapy, and stereotactic body radiotherapy (SBRT), have evolved, aiming to achieve no evidence of disease (NED).
However, not all patients benefit from liver metastasis surgical resection, and the number of liver metastases is a crucial factor influencing the prognosis of colorectal cancer patients undergoing liver surgery. In the 1970s and 1980s, it was considered a contraindication for surgery if there were more than 3 liver metastatic lesions. In a subsequent phase II clinical trial, the CLOCC study, 119 initially unresectable colorectal cancer patients with fewer than 10 metastatic lesions were randomized into either palliative chemotherapy (control group) or systemic chemotherapy combined with liver ablation ± surgical resection (experimental group). The overall survival of patients in the combination therapy group was significantly higher than that in the palliative chemotherapy group (HR=0.58, 95% CI 0.38-0.88, p=0.01). The 3-year, 5-year, and 8-year survival rates in the combination therapy group were 56.9%, 43.1%, and 35.9%, respectively, confirming that for colorectal cancer patients with fewer than 10 unresectable liver metastases, the efficacy of systemic chemotherapy combined with surgery and ablation therapy is superior to palliative chemotherapy alone.
To explore the impact of surgical resection on the survival of colorectal cancer patients with ≥10 liver metastases after first-line treatment, several retrospective studies have been conducted. A study by L. Viganò et al. found that in 106 colorectal cancer patients with ≥8 metastatic lesions, the 5-year survival rate and 5-year recurrence-free survival rate after surgical resection were 20.1% and 13.6%, respectively. There was no significant difference in the 5-year survival rate among patients with 8-10, 10-15, and ≥15 metastatic lesions (p=0.848). Multifactorial analysis of patients with ≥ 8 metastatic lesions showed that the presence of extrahepatic lesions before surgery (HR=2.38, 95% CI 1.23-4.60, p=0.010) and poor response to preoperative chemotherapy (HR=2.14, 95% CI 1.11-4.12, p=0.023) were independent risk factors for overall survival in patients with ≥10 CRLM. Another large observational study by M. A. Allard included 529 patients with ≥10 liver metastases, yielding an overall 5-year survival rate of 30%. Among the colorectal cancer patients with ≥10 lesions, 68.4% (362/529) received chemotherapy before surgery, and 96.3% of these patients underwent surgical resection when the disease was controlled or stable. 72.8% patients underwent R0 or R1 ± ablation therapy, while 27.2% underwent R2 resection or did not undergo surgical resection. Patients who underwent R0 resection and R1 resection ± ablation therapy had better 3-year and 5-year survival rates than those who underwent R2 resection or did not undergo surgical resection (61% and 39% vs. 29% and 5%; p<0.0001). The study also found that among these patients, there was no significant difference in the 3-year and 5-year survival rates between those who underwent R0 resection and R1 resection ± ablation therapy (73% and 45% vs. 60% and 44%; p<0.72), and those who underwent R2 resection or did not undergo surgical resection (29% and 6% vs. 28% and 0%; p=0.77). The results of this study also showed that among patients with ≥10 CRLM, those who underwent MRI before surgery, achieved R0/R1 resection, and received adjuvant therapy after surgery had a longer survival.
Furthermore, Lin et al. used univariate and multivariate analysis to identify ≥10 liver metastases as an independent prognostic factor for colorectal cancer patients with CRLM (HR=1.629; 95% CI 1.007-2.636; p=0.043). Subsequently, a retrospective study was conducted specifically for colorectal cancer patients with liver metastases using 10 metastases as the cutoff value. The results showed that the conversion rate of patients with ≥10 liver metastases (43.4%) was significantly lower than that of patients with <10 liver metastases (57.3%; p=0.001). Among successfully converted patients, the 2-year survival rate of patients with <10 liver metastases was significantly higher than that of patients with ≥10 liver metastases (89.9% [95% CI 82.5%-98.0%] vs. 58.2% [95% CI 42.2%-80.4%], p=0.008). In patients with ≥10 liver metastases, there was no significant difference in the 2-year survival rate between those who successfully underwent conversion surgery and those who did not (58.2% [95% CI 42.2%-80.4%] vs. 49.6% [95% CI 37.5%-65.7%], p=0.160). For patients with <10 CRLM, the 2-year survival rate of successfully converted patients was significantly higher than that of those who did not convert successfully (89.9% [95% CI 82.5%-98.0%] vs. 58.9% [95% CI 45.2%-76.7%], p<0.001).
In summary, for colorectal cancer patients with liver metastases, adopting a locoregional treatment approach can enhance the survival of those with <10 liver metastatic lesions. However, significant controversy remains regarding whether surgical treatment significantly improves the survival of colorectal cancer patients with ≥10 CRLM. Currently, there is a lack of randomized controlled study data to address the question of whether colorectal cancer patients with ≥10 CRLM can further benefit from chemotherapy plus a surgical approach versus palliative chemotherapy alone.
To that end, the present study will focus on patients with ≥10 CRLM who have achieved disease control in liver metastatic lesions after chemotherapy and can potentially attain a disease-free state through surgery and/or ablation and/or stereotactic body radiotherapy (SBRT). The primary objective of this study is to investigate whether liver-localized intervention can improve the 5-year survival rate compared to palliative chemotherapy, for colorectal cancer patients with ≥10 CRLM.
- Conditions
- Colorectal Neoplasms Malignant
- Being tested
- Surgical resection and/or ablation therapy and/or SBRT, Palliative Chemotherapy
- Keywords
- Colorectal liver metastases, Overall survival, Locoregional treatment, Palliative chemotherapy, Randomized Clinical Study
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resection and/or ablation therapy and/or SBRTProcedure or surgery
Participants may receive surgical resection and/or ablation therapy and/or stereotactic body radiotherapy
Palliative ChemotherapyDrug
Participants in this group may continue the original systemic chemotherapy regimen. Patients with tumor control after 10-12 cycles can either transition to maintenance treatment or temporarily suspend treatment until disease progression, at which point they switch to a second-line treatment regimen.The selection of second-line and subsequent treatment regimens follows CSCO guidelines and clinical practices.
| Study group | Role | What they receive |
|---|---|---|
| Liver-localized treatment group | Experimental | Participants in this group will undergo liver-localized interventions, which may include surgical resection and/or ablation therapy and/or SBRT, aiming to achieve NED. Receives: Procedure: Surgical resection and/or ablation therapy and/or SBRT |
| Palliative chemotherapy only group | Active comparator | Participants in this group will receive standard palliative chemotherapy. The focus is on managing symptoms and controlling the progression of the disease. Receives: Drug: Palliative Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-year survival rate
The proportion of patients who are still alive five years following diagnosis
Measured: Assessed five-year following diagnosis
Secondary outcomes (5)
Median Progression-Free Survival
The duration of time from the initiation of treatments until disease progression or death.
Measured: Assessed throughout the study duration (5 years)
Median Overall Survival
The duration of time from diagnosis until death
Measured: Assessed throughout the study duration (5 years)
Cumulative Incidence of Liver Progression Events
The proportion of patients experiencing disease progression specifically in the liver over the study period.
Measured: Assessed throughout the study duration (5 years)
Cumulative Incidence of Extrahepatic Progression Events
The proportion of patients experiencing disease progression outside the liver over the study period.
Measured: Assessed throughout the study duration (5 years)
Treatment-related Adverse Events
Assessment of adverse events related to surgical interventions, including but not limited to complications compared to palliative chemotherapy
Measured: Assessed throughout the study duration (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Jan 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Neoplasms MalignantStudies of the same condition, open and under way.
- More trials run by 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
- Model description
- The participants who meet the inclusion criteria will be grouped using a stratified block randomization method. The stratification factors include the entire RAS/BRAF gene (wild-type vs. mutated), the number of liver metastases (10-20 vs. \>20), and the location of the primary lesion (left vs. right). The random grouping of participants will be accomplished using our center's Interactive Web Response System (IWRS). The participants will be randomly assigned to either the liver-localized treatment group or the palliative chemotherapy group in a 2:1 ratio.
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuhong Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208371
- Sponsor's protocol ID
- DECIDE-CRLM-10
- Status last verified
- May 2025
- First submitted
- 5 Jan 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data and materials used in this study can be made available following study completion upon reasonable request to the corresponding author, subject to ethical and legal considerations and applicable data-sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DECIDE-CRLM-10 Randomized Controlled Study: Comparison of Chemotherapy Combined With Localized Treatment for Liver Metastases Versus Palliative Chemotherapy Alone in Colorectal Patients With 10 or More Liver Metastases
- ClinicalTrials.gov ID
- NCT06208371
- Acronym / sponsor ID
- DECIDE-CRLM-10
- Conditions
- Colorectal Neoplasms Malignant
- Keywords
- Colorectal liver metastases, Overall survival, Locoregional treatment, Palliative chemotherapy, Randomized Clinical Study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Jan 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 clinical trial is to investigate the effectiveness of localized interventions in improving the 5-year survival rate for colorectal cancer patients with ≥10 liver metastases. We aim to answer the following question:
Can localized interventions, including surgery and/or ablation and/or stereotactic body radiotherapy (SBRT), enhance the 5-year survival rate compared to palliative chemotherapy alone in patients with ≥10 colorectal liver metastases (CRLM)?
Participants in this study, who have achieved disease control through chemotherapy, will undergo either localized interventions (surgery and/or ablation and/or SBRT) or receive palliative chemotherapy alone. Researchers will compare the survival outcomes between these groups to determine the potential benefits of localized interventions for patients with ≥10 CRLM.
Detailed description
Colorectal cancer is one of the most common malignant tumors, ranking second globally in cancer-related mortality. In recent years, both the incidence and mortality rates of colorectal cancer in China have shown a gradual upward trend. According to literature reports, 20% of colorectal cancer patients are diagnosed with liver metastases (CRLM), and as the disease progresses, up to 50% of patients may develop liver metastases, a primary cause of treatment failure for these patients. Surgical resection of liver metastases remains the main curative treatment for colorectal cancer patients, with 5-year and 10-year survival rates reaching 33% and 23%, respectively. However, only 15%-20% of patients are eligible for liver surgery. Advances in targeted drugs and systemic chemotherapy in recent years have improved the response rate of colorectal cancer patients with liver metastases. Several clinical studies confirm that neoadjuvant chemotherapy can reduce the size and stage of liver metastases, allowing initially unresectable patients the opportunity for surgical intervention. Simultaneously, various local treatment modalities for colorectal liver metastases, including surgery, ablation therapy, and stereotactic body radiotherapy (SBRT), have evolved, aiming to achieve no evidence of disease (NED).
However, not all patients benefit from liver metastasis surgical resection, and the number of liver metastases is a crucial factor influencing the prognosis of colorectal cancer patients undergoing liver surgery. In the 1970s and 1980s, it was considered a contraindication for surgery if there were more than 3 liver metastatic lesions. In a subsequent phase II clinical trial, the CLOCC study, 119 initially unresectable colorectal cancer patients with fewer than 10 metastatic lesions were randomized into either palliative chemotherapy (control group) or systemic chemotherapy combined with liver ablation ± surgical resection (experimental group). The overall survival of patients in the combination therapy group was significantly higher than that in the palliative chemotherapy group (HR=0.58, 95% CI 0.38-0.88, p=0.01). The 3-year, 5-year, and 8-year survival rates in the combination therapy group were 56.9%, 43.1%, and 35.9%, respectively, confirming that for colorectal cancer patients with fewer than 10 unresectable liver metastases, the efficacy of systemic chemotherapy combined with surgery and ablation therapy is superior to palliative chemotherapy alone.
To explore the impact of surgical resection on the survival of colorectal cancer patients with ≥10 liver metastases after first-line treatment, several retrospective studies have been conducted. A study by L. Viganò et al. found that in 106 colorectal cancer patients with ≥8 metastatic lesions, the 5-year survival rate and 5-year recurrence-free survival rate after surgical resection were 20.1% and 13.6%, respectively. There was no significant difference in the 5-year survival rate among patients with 8-10, 10-15, and ≥15 metastatic lesions (p=0.848). Multifactorial analysis of patients with ≥ 8 metastatic lesions showed that the presence of extrahepatic lesions before surgery (HR=2.38, 95% CI 1.23-4.60, p=0.010) and poor response to preoperative chemotherapy (HR=2.14, 95% CI 1.11-4.12, p=0.023) were independent risk factors for overall survival in patients with ≥10 CRLM. Another large observational study by M. A. Allard included 529 patients with ≥10 liver metastases, yielding an overall 5-year survival rate of 30%. Among the colorectal cancer patients with ≥10 lesions, 68.4% (362/529) received chemotherapy before surgery, and 96.3% of these patients underwent surgical resection when the disease was controlled or stable. 72.8% patients underwent R0 or R1 ± ablation therapy, while 27.2% underwent R2 resection or did not undergo surgical resection. Patients who underwent R0 resection and R1 resection ± ablation therapy had better 3-year and 5-year survival rates than those who underwent R2 resection or did not undergo surgical resection (61% and 39% vs. 29% and 5%; p<0.0001). The study also found that among these patients, there was no significant difference in the 3-year and 5-year survival rates between those who underwent R0 resection and R1 resection ± ablation therapy (73% and 45% vs. 60% and 44%; p<0.72), and those who underwent R2 resection or did not undergo surgical resection (29% and 6% vs. 28% and 0%; p=0.77). The results of this study also showed that among patients with ≥10 CRLM, those who underwent MRI before surgery, achieved R0/R1 resection, and received adjuvant therapy after surgery had a longer survival.
Furthermore, Lin et al. used univariate and multivariate analysis to identify ≥10 liver metastases as an independent prognostic factor for colorectal cancer patients with CRLM (HR=1.629; 95% CI 1.007-2.636; p=0.043). Subsequently, a retrospective study was conducted specifically for colorectal cancer patients with liver metastases using 10 metastases as the cutoff value. The results showed that the conversion rate of patients with ≥10 liver metastases (43.4%) was significantly lower than that of patients with <10 liver metastases (57.3%; p=0.001). Among successfully converted patients, the 2-year survival rate of patients with <10 liver metastases was significantly higher than that of patients with ≥10 liver metastases (89.9% [95% CI 82.5%-98.0%] vs. 58.2% [95% CI 42.2%-80.4%], p=0.008). In patients with ≥10 liver metastases, there was no significant difference in the 2-year survival rate between those who successfully underwent conversion surgery and those who did not (58.2% [95% CI 42.2%-80.4%] vs. 49.6% [95% CI 37.5%-65.7%], p=0.160). For patients with <10 CRLM, the 2-year survival rate of successfully converted patients was significantly higher than that of those who did not convert successfully (89.9% [95% CI 82.5%-98.0%] vs. 58.9% [95% CI 45.2%-76.7%], p<0.001).
In summary, for colorectal cancer patients with liver metastases, adopting a locoregional treatment approach can enhance the survival of those with <10 liver metastatic lesions. However, significant controversy remains regarding whether surgical treatment significantly improves the survival of colorectal cancer patients with ≥10 CRLM. Currently, there is a lack of randomized controlled study data to address the question of whether colorectal cancer patients with ≥10 CRLM can further benefit from chemotherapy plus a surgical approach versus palliative chemotherapy alone.
To that end, the present study will focus on patients with ≥10 CRLM who have achieved disease control in liver metastatic lesions after chemotherapy and can potentially attain a disease-free state through surgery and/or ablation and/or stereotactic body radiotherapy (SBRT). The primary objective of this study is to investigate whether liver-localized intervention can improve the 5-year survival rate compared to palliative chemotherapy, for colorectal cancer patients with ≥10 CRLM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants who meet the inclusion criteria will be grouped using a stratified block randomization method. The stratification factors include the entire RAS/BRAF gene (wild-type vs. mutated), the number of liver metastases (10-20 vs. >20), and the location of the primary lesion (left vs. right). The random grouping of participants will be accomplished using our center's Interactive Web Response System (IWRS). The participants will be randomly assigned to either the liver-localized treatment group or the palliative chemotherapy group in a 2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Liver-localized treatment group | Experimental | Procedure: Surgical resection and/or ablation therapy and/or SBRTParticipants in this group will undergo liver-localized interventions, which may include surgical resection and/or ablation therapy and/or SBRT, aiming to achieve NED. |
| Palliative chemotherapy only group | Active comparator | Drug: Palliative ChemotherapyParticipants in this group will receive standard palliative chemotherapy. The focus is on managing symptoms and controlling the progression of the disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Baseline imaging (CT, MRI, or PET/CT as necessary) or pathological confirmation of liver metastasis, with no extrahepatic metastasis (consideration for inclusion may be given to lesions with a diameter less than 10mm in the lungs or lymph nodes if metastasis is difficult to confirm or is suspected).
- Disease control (PR or SD) achieved after a minimum of 8 cycles of systemic chemotherapy.
- Evaluation by a centralized liver surgeon expert group to confirm presence of ≥10 liver metastases, which can be managed through surgery and/or ablation and/or SBRT to achieve NED. Non-resectability is defined as one or more of the following: ① Unable to undergo R0 resection; ② Predicted insufficient remaining liver volume after resection; ③ After resection, none of the three hepatic veins can be preserved, and the preservation of residual liver inflow and outflow and bile ducts cannot be guaranteed, and adjacent two liver segments cannot be preserved.
Key exclusion criteria (12 listed)
- Definite presence of extrahepatic metastasis and/or primary tumor not amenable to curative surgical resection.
- Severe arterial embolism or ascites.
- Bleeding tendencies or coagulation disorders.
- Hypertensive crisis or hypertensive encephalopathy.
- Severe uncontrollable systemic complications such as infection or diabetes.
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 |
|---|---|---|
| Surgical resection and/or ablation therapy and/or SBRTParticipants may receive surgical resection and/or ablation therapy and/or stereotactic body radiotherapy | Procedure or surgery | Liver-localized treatment group |
| Palliative ChemotherapyParticipants in this group may continue the original systemic chemotherapy regimen. Patients with tumor control after 10-12 cycles can either transition to maintenance treatment or temporarily suspend treatment until disease progression, at which point they switch to a second-line treatment regimen.The selection of second-line and subsequent treatment regimens follows CSCO guidelines and clinical practices. | Drug | Palliative chemotherapy only group |
Primary outcome
Five-year survival rate
Time frame: Assessed five-year following diagnosis
The proportion of patients who are still alive five years following diagnosis
5 secondary outcomes
Median Progression-Free Survival
Time frame: Assessed throughout the study duration (5 years)
Median Overall Survival
Time frame: Assessed throughout the study duration (5 years)
Cumulative Incidence of Liver Progression Events
Time frame: Assessed throughout the study duration (5 years)
Cumulative Incidence of Extrahepatic Progression Events
Time frame: Assessed throughout the study duration (5 years)
Treatment-related Adverse Events
Time frame: Assessed throughout the study duration (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 30 May 2025.
- Individual participant dataSharing planned: Undecided. Data and materials used in this study can be made available following study completion upon reasonable request to the corresponding author, subject to ethical and legal considerations and applicable data-sharing agreements.
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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.
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 Surgical resection and/or ablation therapy and/or SBRT and Palliative Chemotherapy in people with Colorectal Neoplasms Malignant, run by 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 13 inclusion and 12 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 30 May 2025. 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?
Contact Yuhong Li, PhD (87342487 ext. 020, liyh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-year survival rate (time frame: Assessed five-year following diagnosis). 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 30 May 2025.