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New treatment option for Cholangiocarcinoma Non-resectable
Official title En Bloc Resection of the Liver and Pancreas With a "Non-touch" Technique Followed by Liver Transplantation to Improve the Overall Survival in Patients With Non-resectable Hilar Cholangiocarcinoma Beyond the Mayo Clinic Transplant Criteria
ClinicalTrials.gov ID: NCT06850753
What this study is testing
- What it's testing
- Surgery for hilar cholangiocarcinoma (phCCA) remains a significant challenge. The minority of patients who are eligible for resection are exposed to high procedure-related morbidity and mortality, and despite apparent R0 resection, cancer recurrence is common.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Histologically verified or strong suspicion of cholangiocarcinoma based on radiology and endoscopy and elevated Ca 19-9 \> 100U/L
- Perihilar cholangiocarcinoma that is deemed unresectable based on tumor location or severity of the underlying liver disease. Perihilar recurrence in...
- Patients should not be eligible for liver transplantation according to the Mayo protocol criteria.
- Tumor involvement of the hepatic artery distal to the gastroduodenal artery or the portal vein without tumor thrombus is accepted.
- No evidence of distant metastasis or metastatic lymph node (M1) involvement (para-aortic, coeliac or para-colic)
You likely can't join if
- Radiological signs of tumor invasion along intended resection borders
- Direct tumor invasion of the pancreatic head
- Signs of spread to the para-aortic, superior mesenteric, or coeliac lymph nodes
- Perforation of the visceral peritoneum
- Weight loss \>10% in the last six months
- Patient BMI \> 30 kg/m2
See the full eligibility criteria
- Histologically verified or strong suspicion of cholangiocarcinoma based on radiology and endoscopy and elevated Ca 19-9 \> 100U/L
- Perihilar cholangiocarcinoma that is deemed unresectable based on tumor location or severity of the underlying liver disease. Perihilar recurrence in PSC patients more than 24 months following the previous resection...
- Patients should not be eligible for liver transplantation according to the Mayo protocol criteria.
- Tumor involvement of the hepatic artery distal to the gastroduodenal artery or the portal vein without tumor thrombus is accepted.
- No evidence of distant metastasis or metastatic lymph node (M1) involvement (para-aortic, coeliac or para-colic)
- Good performance status Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
- At least 6 months of observation time during which the patient should be treated by chemotherapy and radiation (hyperfractioned 30-50 Gy) with response or stable disease before listing for LT. Patients with PSC and...
- Radiological signs of tumor invasion along intended resection borders
- Direct tumor invasion of the pancreatic head
- Signs of spread to the para-aortic, superior mesenteric, or coeliac lymph nodes
- Perforation of the visceral peritoneum
- Weight loss \>10% in the last six months
- Patient BMI \> 30 kg/m2
- Other malignancies, except curatively treated basal cell carcinoma or other tumors with disease-free interval \> five years without relapse. The final decision on acceptable previous cancer diagnoses is at the principal...
- Known history of human immunodeficiency virus (HIV) infection
- 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 metastatic disease
- Women who are pregnant or breastfeeding
- 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 to 70 years. 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.