Recruiting PHASE2 Metastatic Colorectal Cancer

New treatment option for Metastatic Colorectal Cancer

Official title Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

ClinicalTrials.gov ID: NCT05854498

What this study is testing

What is Liposomal irinotecan?

Liposomal irinotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.

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 study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.
  • Phase 2: a mid-size study of how well it works
  • Time commitment: about 12 months

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

  • Patients must be ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1.
  • Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable.
  • The cancer must be mismatch repair proficient.
  • Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior...

You likely can't join if

  • Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy.
  • Patients whose cancers possess BRAF V600 mutations are excluded.
  • Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy.
  • Patients must not have mismatch repair deficient or microsatellite instability high cancers.
  • Patients must not have received prior TAS102.

The study team makes the final eligibility decision.

Where it's taking place

  • Madison, Wisconsin, United States

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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Madison, Wisconsin, United States. 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.