BridgeMD
New treatment option for Metastatic Colorectal Cancer
Official title Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients
ClinicalTrials.gov ID: NCT06202001
What this study is testing
What is Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab?
Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab is an investigational medicine, given as an once-daily, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as Irinotecan+TAS-102+Bevacizumab.
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
- In mCRC, response to second-line chemotherapy is limited, and few treatment options are available. It is urgent to design an optimal second-line treatment regimen to improve the response rate and prolong the survival of patients with mCRC.
- Phase 2: a mid-size study of how well it works
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 70
You may be able to join if
- Colorectal adenocarcinoma confirmed histologically or histopathologically.
- Patients were clinically diagnosed with metastatic colorectal cancer based on computed tomography (CT) scan and magnetic resonance imaging (MRI)...
- Patients have received oxaliplatin-based first-line chemotherapy with or without targeted therapy, immunotherapy or radiotherapy.
- Age ≥18 and ≤70.
- ECOG physical status score is 0 or 1, and no obvious deterioration within 2 weeks prior to use on Day 1 of Cycle 1.
You likely can't join if
- The pathological types were squamous carcinoma, neuroendocrine carcinoma, adenosquamous carcinoma, and other histological types except adenocarcinoma.
- Patients who had shown hypersensitivity to Irinotecan and Trifluridine/tipiracil (TAS-102) or any other component of them. Patients who previously...
- Known hypersensitivity to Bevacizumab or hypersensitivity to any other component of Bevacizumab.
- Patients unable to swallow or lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral...
- Patients had recurrent episodes of bleeding (risk of gastrointestinal bleeding) or received transfusions in the previous 2 weeks.
- Major surgery in the previous 4 weeks. (Biopsy is excluded)
See the full eligibility criteria
- Colorectal adenocarcinoma confirmed histologically or histopathologically.
- Patients were clinically diagnosed with metastatic colorectal cancer based on computed tomography (CT) scan and magnetic resonance imaging (MRI) according to AJCC 8th edition.
- Patients have received oxaliplatin-based first-line chemotherapy with or without targeted therapy, immunotherapy or radiotherapy.
- Age ≥18 and ≤70.
- ECOG physical status score is 0 or 1, and no obvious deterioration within 2 weeks prior to use on Day 1 of Cycle 1.
- Appropriate organ function according to the following laboratory test values:
- Hemoglobin value ≥90g/L.
- White blood cell count ≥3.5\ 109/L.
- Absolute neutrophil count ≥1.5\ 109/L.
- Platelet count ≥100\ 109/L.
- Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml/min.
- Total serum bilirubin ≤1.5\ upper normal limit (ULN).
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5\ upper limit of normal value (ULN).
- Signed the informed consent.
- The pathological types were squamous carcinoma, neuroendocrine carcinoma, adenosquamous carcinoma, and other histological types except adenocarcinoma.
- Patients who had shown hypersensitivity to Irinotecan and Trifluridine/tipiracil (TAS-102) or any other component of them. Patients who previously received irinotecan while disease progressed. However, patients who...
- Known hypersensitivity to Bevacizumab or hypersensitivity to any other component of Bevacizumab.
- Patients unable to swallow or lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
- Patients had recurrent episodes of bleeding (risk of gastrointestinal bleeding) or received transfusions in the previous 2 weeks.
- Major surgery in the previous 4 weeks. (Biopsy is excluded)
- Previous or concurrent cancer diagnosed within 5 years prior to study inclusion, except for curatively treated in situ cervical cancer, non-melanoma skin cancer, basal cell carcinoma, benign prostate cancer, ductal...
- History of abdominal fistula, gastro-intestinal perforation, intestinal obstruction, chronic diarrhea or inflammatory bowel disease including Crohns disease and ulcerative colitis within 6 months prior to the first...
- Patients with severe cardiac dysfunction, such as LVEF\< 50%, CHF≥ grade 2, severe/unstable angina, history of stroke or transient ischemic attack or myocardial infarction in the previous 6 months.
- Uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic pressure \>100 mmHg despite treatment) and uncontrolled diabetes (fasting plasma glucose \> 8.9 mmol/l).
- Patients with a history of ventricular tachycardia, torsades de pointes, prolonged QTc, complete left bundle branch block or third-degree atrioventricular conduction block.
- Patients with active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus infection.
- Arterial or venous thrombotic or embolic events such as deep vein thrombosis, and pulmonary embolism within 3 months of starting study treatment (catheter-related thrombosis is excluded).
- Patients with active pulmonary tuberculosis were taking anti-tuberculosis treatment or have taken anti-tuberculosis treatment within 12 months of starting study treatment.
- Patients with severe primary respiratory diseases, interstitial lung disease, or history of pneumonitis.
- Patients with current active infections requiring anti-infection treatment within 2 weeks of starting study treatment.
- Patients with a history of psychiatric drug abuse or a history of drug abuse.
- Pregnant or lactating women.
- Patients of childbearing potential are unwilling to practice contraception.
- Patients with any clinically significant disease, metabolic disorders or laboratory abnormality. Investigator could reasonably consider those patients not suitable for the study, affecting the results analysis or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.