Liver Transplant for Bile Duct Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must be taking: Gemcitabine-based therapy

Disqualifiers: Cancer, Metastases, Renal dysfunction, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is an increasingly common form of primary liver cancer, but patients with this diagnosis are not currently eligible for LT. This study proposes to offer LT as an option to patients with advanced, unresectable iCCA who demonstrate at least 6 months of disease stability /regression while receiving standard chemotherapy. Patients will be referred and screened for study participation if they have achieved 6 months of disease stability. They will be worked up for transplant and if eligible, will be listed. Disease must remain controlled while awaiting transplantation. After transplantation, patients will be followed for disease recurrence and overall survival, while receiving standard post-transplantation followup.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients must have at least 6 months of disease stability on gemcitabine-based therapy, suggesting that continuing this treatment might be necessary.

What data supports the effectiveness of the treatment Liver Transplantation for bile duct cancer?

Research shows that liver transplantation for bile duct cancer can lead to favorable survival rates, especially when combined with preoperative therapies. A study found that patients who received liver transplants along with additional treatments had better 1-, 3-, and 5-year survival rates compared to those who only had surgery. ^{1 2 3 4 5}

Is liver transplantation generally safe for treating bile duct cancer?

Liver transplantation for bile duct cancer has been studied, and while it can have complications, the safety profile is considered acceptable. In a study of 605 patients, the incidence of complications was around 62%, but outcomes improved with additional preoperative therapies. ^{3 6 7 8 9}

How is liver transplantation different from other treatments for bile duct cancer?

Liver transplantation for bile duct cancer is unique because it offers a potential cure for patients with non-metastatic cancer that cannot be removed by surgery. Unlike other treatments, it involves replacing the entire liver, which can be a last resort when other options are not viable. ^{6 7 10 11 12}

Research Team

Gonzalo Sapisochin, MD

Principal Investigator

UHN

Eligibility Criteria

This trial is for adults with advanced bile duct cancer (iCCA) that can't be removed by surgery. They must have shown no cancer growth or shrinkage for at least 6 months on chemotherapy, be in good physical condition (ECOG score: 0 or 1), and have a potential living donor. People with other cancers, HIV, poor kidney function, or who are pregnant/breastfeeding cannot join.

Inclusion Criteria

My cancer has not worsened for at least 6 months while on gemcitabine or a second-line therapy.

Able and willing to provide written informed consent

My condition cannot be treated with surgery due to the tumor's location or liver issues.

Exclusion Criteria

You have a history of substance abuse or any medical, psychological, or social conditions that may affect your ability to take part in the study or could affect the study results.

I am not pregnant or breastfeeding, or I am willing to stop breastfeeding.

I have been diagnosed with HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive standard chemotherapy for at least 6 months to demonstrate disease stability or regression

6 months

Pre-Transplant Assessment

Participants undergo pre-transplant assessments and imaging to confirm eligibility for liver transplantation

4 weeks

Transplantation

Eligible participants undergo liver transplantation surgery

1 week

Follow-up

Participants are monitored for tumor recurrence and overall survival with imaging and blood tests for 5 years post-transplant

5 years

Treatment Details

Interventions

• Liver Transplantation

Trial Overview The study is testing liver transplantation as a treatment option for patients with stable advanced intrahepatic cholangiocarcinoma who aren't currently eligible for this procedure. Participants will undergo standard pre-transplant evaluations and post-transplant follow-ups to monitor disease recurrence and survival.

Participant Groups

Group I: liver transplantation Experimental Treatment 1 Intervention

Surgical Intervention - Liver transplantation

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

References

1. Romania pubmed.ncbi.nlm.nih.gov

Intrahepatic cholangiocarcinoma--a rare indication for liver transplantation. Case report and review of the literature. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Changing patterns in diagnosis and management of bile duct cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of liver transplantation in patients with cholangiocarcinoma: a systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Operations for extrahepatic bile duct cancers: are the results really improving? [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of liver transplantation for hilar cholangiocarcinoma: A protocol for a systematic review and meta-analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Liver transplantation for iatrogenic bile duct injuries sustained during cholecystectomy. [2018]

7. China pubmed.ncbi.nlm.nih.gov

[Meta-analysis of efficacy and safety of liver transplantation in treating cholangiocarcinoma]. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Gallbladder cancer and liver transplantation. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Risk of hepatobiliary cancer after solid organ transplant in the United States. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Intrahepatic cholangiocarcinoma: Is there a role for liver transplantation? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Current status of liver transplantation for hilar cholangiocarcinoma. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Liver transplantation: the last measure in the treatment of bile duct injuries. [2021]