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Compares treatment options for Colorectal Cancer Metastatic
Official title Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06992648
What this study is testing
What is Trifluridine/Tipiracil + Regorafenib?
Trifluridine/Tipiracil + Regorafenib is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for colorectal cancer metastatic.
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 demonstrate the non-inferiority of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of progression free survival in patients with refractory metastatic colorectal cancer(mCRC) patients. It will also try to estimate the effect of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of OS, ORR, and DCR in patients with refractory mCRC.
- 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
- Sign Informed Consent Form (ICF) must be obtained during the screening visit, prior to the performance of any study procedure；
- Male or female patient aged ≥18 years old;
- Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded);
- RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy;
- Prior treatment regimens for the treatment of advanced colorectal cancer must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF...
You likely can't join if
- Prior trifluridine/tipiracil or TKI regimens for the treatment of advanced colorectal cancer;
- Pregnancy, lactating female or possibility of becoming pregnant during the study;
- Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization;
- Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding...
- Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease;
- Has severe or uncontrolled active acute or chronic infection;
See the full eligibility criteria
- Sign Informed Consent Form (ICF) must be obtained during the screening visit, prior to the performance of any study procedure；
- Male or female patient aged ≥18 years old;
- Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded);
- RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy;
- Prior treatment regimens for the treatment of advanced colorectal cancer must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody for RAS...
- Has measurable or non-measurable disease as defined by RECIST version 1.1;
- Is able to swallow oral tablets;
- Estimated life expectancy ≥12 weeks;
- ECOG PS 0-1；
- Has adequate organ function as defined by the following laboratory values obtained within 7 days prior to randomization: Absolute neutrophil count ≥1.5×109/L; Platelet count ≥75×109/L; Hemoglobin≥90g/L (7 days without...
- Prior trifluridine/tipiracil or TKI regimens for the treatment of advanced colorectal cancer;
- Pregnancy, lactating female or possibility of becoming pregnant during the study;
- Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization;
- Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation);
- Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease;
- Has severe or uncontrolled active acute or chronic infection;
- Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension;
- Has any clinically significant active hepatitis, including but not limited to Hepatitis B or Hepatitis C Virus infection;
- Known carriers of HIV antibodies;
- Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia;
- Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization;
- Major surgery within 4 weeks prior to randomization (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may...
- Prior radiotherapy if completed less than 2 weeks before randomization, except if provided as a short course for symptoms palliation only;
- Other clinically significant medical conditions; Other malignancies.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, 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.