Phase 1 Liver Cancer Trial, Recruiting NCT05195710 Sponsor: M.D. Anderson Cancer Center Condition: Liver Cancer
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Phase 1 Liver Cancer Trial, Recruiting

NCT05195710
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have colorectal cancer that has spread to the liver, where the tumour is on the borderline of being removable by surgery, or currently cannot be safely removed because there is not enough healthy liver remaining — and where the surgical team believes surgery with a curative goal may still be possible
  • People whose liver scans show that a procedure to redirect blood flow in the liver (called portal vein embolization, or PVE) would be needed to grow the healthy portion of the liver enough before a major liver surgery — either as a single operation or as part of a planned two-stage surgery
  • People who have already received at least four cycles, or approximately two months, of chemotherapy
  • People who are willing and mentally able to provide written consent to participate
  • People who are considered medically and physically fit enough for surgery, as determined by their surgeon

Who may not be able to join:

  • People who have cancer spread to areas outside the liver that would prevent the treatment plan from having a curative goal — though a treatable primary tumour and lung spread may still be allowed if a future plan for local treatment (such as surgery, radiation, or ablation) has been determined by the oncology team
  • People whose healthy liver portion is projected to be too small to realistically reach the required level of improvement, even with treatment (confirm with trial site)
  • People whose general physical functioning falls below a certain level, as measured by standard medical scoring tools (confirm with trial site)
  • People who have high blood pressure in the liver's blood vessels (portal hypertension) or liver scarring (cirrhosis)
  • People whose bilirubin blood level (a marker of liver function) is above a certain threshold before starting, unless they have a specific inherited condition called Gilbert's Disease
  • People whose CEA blood marker (a tumour-related protein) remains above a certain level after four cycles of chemotherapy
  • People whose cancer has clearly continued to grow or spread — based on scans or blood markers after four cycles of chemotherapy — and where the surgical and oncology teams have determined that surgery is no longer a viable option
  • People with a platelet count (a blood clotting measure) below a certain level
  • People with a low albumin level (a protein that reflects nutritional and liver health) in their blood
  • People who still have an active, symptom-causing colon or rectal tumour that has not already been managed with a diverting stoma (a surgically created opening to redirect bowel waste)
  • People who are pregnant or breastfeeding
  • People who have other medical conditions that would make liver surgery unsafe
  • People who do not speak English

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ching-Wei Tzeng, MD, M.D. Anderson Cancer Center

Phone: (713) 792-0386

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
16 November 2022
Est. completion
31 March 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.; The evaluation of using the safety of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov