BridgeMD
New treatment option for Colorectal Liver Metastases
Official title Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases
ClinicalTrials.gov ID: NCT07117435
What this study is testing
What is paclitaxel cationic liposome for injection?
paclitaxel cationic liposome for injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal liver metastases.
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
- This is a phase Ib/III, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.
- Phase 1: an early, usually small safety 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 to 75
You may be able to join if
- 1\. Age range: 18 - 75 years old (inclusive), gender not limited.
- 2\. For patients with colorectal liver metastases have been histologically or cytologically confirmed and who are assessed by multidisciplinary team...
- Have not received systemic treatment for the metastatic or recurrent disease;
- For patients who have received neoadjuvant/adjuvant therapy before, the time interval between the last administration and disease progression must be...
- Allow patients who have received local treatment and progressed.
You likely can't join if
- 1\. Patients known to have microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR), and have been evaluated by the investigators...
- 2\. Patients known to have wild-type RAS and BRAF, and have been evaluated by the investigators to be eligible for anti-epidermal growth factor...
- 3\. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other...
- 4\. Central nervous system metastasis with clinical symptoms, or meningeal metastasis, or there are other evidences indicating that the patient's...
- 5\. Patients with contraindications for transcatheter arterial infusion.
- 6\. Patients with active infections within 2 weeks prior to administration (NCI CTC AE v5.0 ≥ grade 2) (Defined as requiring intravenous...
See the full eligibility criteria
Who can join
- 1\. Age range: 18 - 75 years old (inclusive), gender not limited.
- 2\. For patients with colorectal liver metastases have been histologically or cytologically confirmed and who are assessed by multidisciplinary team (MDT) to be inoperable for radical surgical resection:
- Have not received systemic treatment for the metastatic or recurrent disease;
- For patients who have received neoadjuvant/adjuvant therapy before, the time interval between the last administration and disease progression must be ≥ 6 months;
- Allow patients who have received local treatment and progressed.
- 3\. According to RECIST v1.1, at least one measurable lesion in the hepatic arterial infusion area (long diameter ≥ 1 cm and no previous local treatment).
- 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- 5\. Life expectancy of at least 3 months.
- 6\. Adequate organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factors within 14 days)
- 7\. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the study and for at least 6 months after the...
- 8\. Fully understand the clinical study and voluntarily sign a written informed consent form.
What rules you out
- 1\. Patients known to have microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR), and have been evaluated by the investigators to be eligible for immune checkpoint inhibitor therapy.
- 2\. Patients known to have wild-type RAS and BRAF, and have been evaluated by the investigators to be eligible for anti-epidermal growth factor receptor (EGFR) drug therapy.
- 3\. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigators).
- 4\. Central nervous system metastasis with clinical symptoms, or meningeal metastasis, or there are other evidences indicating that the patient's central nervous system metastasis or meningeal metastatic lesions have...
- 5\. Patients with contraindications for transcatheter arterial infusion.
- 6\. Patients with active infections within 2 weeks prior to administration (NCI CTC AE v5.0 ≥ grade 2) (Defined as requiring intravenous administration of antibacterial, antifungal or antiviral drugs for treatment).
- 7\. Patients with grade 2 or above peripheral neuropathy (NCI CTC AE v5.0).
- 8\. Patients with a history of autoimmune diseases, immunodeficiency disorders, including HIV positive test results, or suffering from other acquired or congenital immune deficiencies, or those currently using...
- 9\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with HBV DNA ≥ 2×103 IU/mL (can use continuous antiviral treatment); or anti-hepatitis C virus antibody (HCV-Ab) positive with HCV...
- 10\. Patients with known contraindications to capecitabine or oxaliplatin, paclitaxel or cationic liposome, or have severe allergic reactions; note: If the subject has contraindications to bevacizumab or has severe...
- 11\. Patients need to receive strong inducers and strong inhibitors of CYP2C8 and CYP3A4 within 2 weeks before the first study treatment or during the treatment.
- 12\. Patients had or have non-infectious pneumonia/interstitial lung disease that requires systemic glucocorticoid treatment.
- 13\. Severe cardiovascular disease history, including but not limited to:
- Long QT syndrome;
- High-degree atrioventricular block;
- Severe arrhythmia that is not well controlled by medication;
- Chronic heart failure history and NYHA cardiac function classification ≥ 3;
- Severe valvular regurgitation or stenosis that requires treatment;
- Acute coronary syndrome or severe myocardial disease within 6 months before screening;
- Uncontrolled hypertension;
- Echocardiography suggests LVEF \< 50%;
- 14\. Patients with a previous history of severe neurological or mental disorders (including epilepsy or dementia) lead to compliance issues.
- 15\. Patients with ultrasound-detected limb vascular thrombosis with potentially serious consequences during screening, or who with thromboembolic events within 3 months prior to enrollment.
- 16\. Patients with a history of severe bleeding, or who experienced major bleeding events such as intracranial hemorrhage, gastrointestinal bleeding, or purpura within the last 3 months.
- 17\. Any other reasons deemed by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Lishui, Zhejiang, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lishui, Zhejiang, 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.