BridgeMD
Compares treatment options for Colorectal Neoplasms Malignant
Official title Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM
ClinicalTrials.gov ID: NCT06208371
What this study is testing
What is Palliative Chemotherapy?
Palliative Chemotherapy is an investigational medicine, being studied as a potential treatment for colorectal neoplasms malignant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)?
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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.
- side effects 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.