BridgeMD
Randomized and multicentre Phase II study of FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab) alone or in combination with hepatic chemoembolization (Lifepearls-Irinotecan) in patients with colorectal cancer and metastatic disease limited to the liver with bad prognosis.
EU CTIS ID: 2024-517782-16-00
What this study is testing
To evaluate the radiological objective response rate according to the RECIST version 1.1 criteria at 6 months.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged ≥ 18 years.
- Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size > 5 cm. Patients with the diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable. Patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery. If the primary tumor has not been resected, it must be clinically stable.
- Measurable disease following RECIST version 1.1 criteria
- Adequate bone marrow function, according to: a. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study b. Platelet count ≥ 100 x 109 / L c. Absolute neutrophil count (ANC) ≥ 1.5x 109 / L
- Adequate liver function, based on: a. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN . c. alkaline phosphatase ≤ 5xULN d. Adequate renal function, with creatinine <1.5 mg / dL. BUN < 50 mg / dL and blood urea levels < 18 mmol/L. e. Albumin> 3.0 g / dL
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
You likely can't join if
- Extent of the disease> 50% of the liver parenchyma (assessed by CT performed within the month prior to inclusion)
- Portal thrombosis
- Severe Hypertension
- Extrahepatic metastases
- Patients with liver metastases measuring less than 5 cm or with a total of 3 or fewer lesions. It should be taken into account that patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery.
- Prior chemotherapy treatment for metastatic colorectal cancer
See the full eligibility criteria
Who can join
- Patients aged ≥ 18 years.
- Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size > 5 cm. Patients with the diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable. Patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery. If the primary tumor has not been resected, it must be clinically stable.
- Measurable disease following RECIST version 1.1 criteria
- Adequate bone marrow function, according to: a. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study b. Platelet count ≥ 100 x 109 / L c. Absolute neutrophil count (ANC) ≥ 1.5x 109 / L
- Adequate liver function, based on: a. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN . c. alkaline phosphatase ≤ 5xULN d. Adequate renal function, with creatinine <1.5 mg / dL. BUN < 50 mg / dL and blood urea levels < 18 mmol/L. e. Albumin> 3.0 g / dL
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Patients capable of understanding the information and giving their written informed consent to participate in the study
- Women and men of childbearing age must commit to abstinence from sexuality or use barrier contraceptive methods during the study and must have a negative pregnancy test.
What rules you out
- Extent of the disease> 50% of the liver parenchyma (assessed by CT performed within the month prior to inclusion)
- Portal thrombosis
- Severe Hypertension
- Extrahepatic metastases
- Patients with liver metastases measuring less than 5 cm or with a total of 3 or fewer lesions. It should be taken into account that patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery.
- Prior chemotherapy treatment for metastatic colorectal cancer
- Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before trial inclusion), myocardial infarction (≤ 6 months prior to trial inclusion), unstable angina, uncontrolled hypertension, NYHA grade II or higher congestive heart failure, or severe cardiac arrhythmia.
- History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.
- Altered coagulation (Quick> 50%)
- Patients with active infectious processes
- Patients with any of the contraindications specified in the technical data sheet of the drug under study or with allergies to some of the drugs used
- Pregnant or lactating patients
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.