AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM

RecruitingPhase 3Ages 18 Years - anyAllSun Yat-sen University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ10 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 โ‰ฅ10 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 โ‰ฅ10 CRLM.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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 โ‰ฅ10 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: โ‘  Unable to undergo R0 resection; โ‘ก Predicted insufficient remaining liver volume after resection; โ‘ข 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. * 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. Exclusion Criteria: * 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. * 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.
๐Ÿ’Š

What it tests

  • Surgical resection and/or ablation therapy and/or SBRT
  • Palliative Chemotherapy
๐Ÿ“

Where

1 site
Sun Yat-sen Cancer Center
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy