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New treatment option for Perihilar Cholangiocarcinoma
Official title Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
ClinicalTrials.gov ID: NCT04993131
What this study is testing
- What it's testing
- The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation.
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
- Radiologically strong suspicion of pCCA
- Tumor can involve intrahepatic portal vein without thrombosis of extrahepatic portal vein
- Tumor can involve hepatic artery distal to gastroduodenal artery or involve replaced hepatic artery
- First time pCCA
- Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction
You likely can't join if
- Tumor involving common hepatic artery, celiac trunck or superior mesenteric artery the tumor
- Tumor involving main portal vein
- Tumor involving inferior vena cava
- Perforation of the visceral peritoneum
- Weight loss \>15% the last 6 months
- Patient BMI \> 30
See the full eligibility criteria
- Radiologically strong suspicion of pCCA
- Tumor can involve intrahepatic portal vein without thrombosis of extrahepatic portal vein
- Tumor can involve hepatic artery distal to gastroduodenal artery or involve replaced hepatic artery
- First time pCCA
- Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction
- No extrahepatic disease, or lymph node involvement detected on imaging
- No signs of extrahepatic metastatic disease according to PET-CT scan
- No signs of extrahepatic metastatic disease according to CT or MR (chest/abdomen/pelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit
- At least 18 years of age
- Good performance status, Eastern Cooperative Oncology Group (ECOG) score: 0 or 1
- Satisfactory blood tests Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>50, Bilirubin\<3 x upper normal level, ASAT, ALAT\<5 x upper normal level, Creatinine \<1.5 x upper normal level. Albumin above lower...
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations
- Received chemotherapy for at least 6 months with at least 10% response according ti RECIST criteria and with no progression of disease at time of Lt
- At least 10 months from diagnosis
- Patient must be accepted for transplantation before progressive disease
- Twelve months or more time span from the diagnosis of pCCA and date of being listed for liver transplantation
- Tumor involving common hepatic artery, celiac trunck or superior mesenteric artery the tumor
- Tumor involving main portal vein
- Tumor involving inferior vena cava
- Perforation of the visceral peritoneum
- Weight loss \>15% the last 6 months
- Patient BMI \> 30
- Other malignancies, except curatively treated more than 5 years ago without relapse
- Known history of human immunodeficiency virus (HIV) infection
- Prior history of solid organ or bone marrow transplantation
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Known hypersensitivity to rapamycin
- Prior extrahepatic metastatic disease
- Women who are pregnant or breast feeding
- Any reason why, in the opinion of the investigator, the patient should not participate
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
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 Oslo, Norway. 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.