Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM
ConditionColorectal Neoplasms Malignant
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Surgical resection and/or ablation therapy and/or SBRT
Procedure/SurgeryParticipants may receive surgical resection and/or ablation therapy and/or stereotactic body radiotherapy
Palliative Chemotherapy
DrugParticipants 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.
Treatment groups
117 Participants
are divided into 2 treatment groupsGroup A: Liver-localized treatment groupExperimental treatment 1 intervention
Group B: Palliative chemotherapy only groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Five-year survival rate
The proportion of patients who are still alive five years following diagnosis
Time frame
Assessed five-year following diagnosisSecondary outcomes
1
Median Progression-Free Survival
The duration of time from the initiation of treatments until disease progression or death.
Time frame
Assessed throughout the study duration (5 years)2
Median Overall Survival
The duration of time from diagnosis until death
Time frame
Assessed throughout the study duration (5 years)3
Cumulative Incidence of Liver Progression Events
The proportion of patients experiencing disease progression specifically in the liver over the study period.
Time frame
Assessed throughout the study duration (5 years)4
Cumulative Incidence of Extrahepatic Progression Events
The proportion of patients experiencing disease progression outside the liver over the study period.
Time frame
Assessed throughout the study duration (5 years)Sponsors and contacts
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Source ClinicalTrials.gov