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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores liver transplants as a potential treatment for bile duct cancer that cannot be surgically removed. The researchers aim to determine if patients with intrahepatic cholangiocarcinoma (iCCA) and stable disease after chemotherapy can benefit from a liver transplant. Participants must have controlled their bile duct cancer for at least six months with chemotherapy and have a willing living donor. After the transplant, doctors will monitor patients for cancer recurrence and overall survival. As an unphased trial, this study provides a unique opportunity for patients to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that liver transplantation is safe for patients with bile duct cancer?

Research has shown that liver transplants can be a safe treatment for certain liver cancers, such as bile duct cancer and intrahepatic cholangiocarcinoma (iCCA). Studies have found that patients receiving liver transplants for cancer can live for many years. Specifically, some studies reported that about 65% to 69% of patients with small tumors lived for at least five years post-transplant.

These findings suggest that liver transplants are generally well-tolerated by patients with liver cancer. Although all surgeries carry risks, evidence supports liver transplants as a viable treatment for certain liver cancers. This approach could be a safe option for individuals with advanced iCCA that cannot be surgically removed, provided the cancer remains stable before the transplant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for bile duct cancer, which typically involve surgery, chemotherapy, or radiation, liver transplantation offers a unique approach. Researchers are excited about liver transplantation because it can potentially provide a complete cure by replacing the cancer-affected liver with a healthy one. This method targets the root of the problem, addressing both the cancer and any underlying liver disease, which current treatments may not fully resolve. Additionally, this approach could improve survival rates and quality of life for patients with bile duct cancer, which is notoriously challenging to treat.

What evidence suggests that liver transplantation could be an effective treatment for bile duct cancer?

Research has shown that liver transplants can be a promising treatment for intrahepatic cholangiocarcinoma (iCCA), a type of liver cancer. Studies indicate that patients who receive a liver transplant often live longer than those who undergo traditional surgery. For instance, more than 70% of liver transplant patients survive for at least five years, compared to a 30% to 40% survival rate for those who only have surgery. Although liver transplants for iCCA were uncommon in the past, recent evidence suggests they could improve long-term survival chances. Participants in this trial will undergo liver transplantation as the primary treatment under study. ^{2 5 6 7 8}

Who Is on the Research Team?

Gonzalo Sapisochin, MD

Principal Investigator

UHN

Are You a Good Fit for This Trial?

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.

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

Able and willing to provide written informed consent

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9667791/

Outcomes After Liver Transplantation With Incidental ... Finally, patients with PSC and early pCCA (pT1-2; n = 22) had 1-, 3-, and 5-year estimated survival rates of 63.6% (95% CI: 40.3%–79.9%), 39.1% (95% CI: 18.9%– ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X25002707

Liver transplant for intrahepatic cholangiocarcinoma The overall 5-year survival rate after curative-intent resection ranges between 30% and 40%, with some studies suggesting a cure probability of ...

3. nature.com nature.com/articles/s41598-023-37896-2

Liver transplantation for intrahepatic cholangiocarcinoma The 1-year and 5-year OS rates in patients with HCC after LT exceed 85% and 70%, respectively, in most centers. Historically, LT has not been ...

4. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2022/11000/liver_transplantation_as_a_new_standard_of_care_in.15.aspx

Liver Transplantation as a New Standard of ... This multicenter benchmark study demonstrates that LT offers excellent outcomes with superior oncological results in early stage PHC patients, even in ...

5. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=259&NCDId=70&ncdver=2&ver=1&NcaName=Liver+Transplantation+for+Malignancies+

NCA - Liver Transplantation for Malignancies (CAG-00091R) The data from single-institution series are limited, but compiled reviews have reported 1- and 10-year survival rates of 96% and 72%, respectively.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK95322/

Efficacy and safety of liver transplantation in patients with ... In comparison to curative resection of cholangiocarcinoma with the 5-year survival rate reported from 20 to 40%, the role of liver transplantation alone is so ...

7. jogs.org jogs.org/article/S1091-255X(25)00270-7/fulltext

Liver transplant for intrahepatic cholangiocarcinoma In their analysis, 5-year survival was 69% for tumors of ≤2 cm and 65% for tumors of >2 to 5 cm (P =.4). These data suggest that patients with ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00708877

Liver Transplantation for Cholangiocarcinoma Today, available therapies for hilar cholangiocarcinomas (CCA) are not satisfactory. Although these tumors are rare, their study is important because of the ...