Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Klatskin Tumor

Urinary Bladder Neoplasms

Biliary Tract Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Immunomodulating Agents

Durvalumab

Tremelimumab

Antimetabolites

Antineoplastic Agents, Immunological

Durvalumab at a fixed dose of 1500 mg as an IV infusion over 1 hour, on day 1 together with the Tremelimumab infusion. Durvalumab only infusion to be repeated every 4 weeks for a maximum of 12 months on day 1 of each cycle.

Tremelimumab at a fixed dose of 300 mg as an IV infusion over 1 hour on day 1 of cycle 1.

Capecitabine at 1250 mg/m² p.o. twice a day on days 1 to 14 of a 3-weekly cycle (eight cycles).

Salah Al-Batran, Prof. Dr.

Thorsten O. Götze, Prof. Dr.

This is an interventional, prospective multicenter, open-label, phase II study in patients after curative surgery for BTC in a classic adjuvant situation, consisting of a two arm feasibility pilot part with a randomized pick-the-winner design and an option to proceed into a randomized phase 2/3 trial in order to compare the winner with the current SOC (capecitabine).

The primary objective is to assess the anti-tumor activity of the combination of durvalumab and tremelimumab with or without capecitabine by the recurrence-free survival rate after 12 months (RFS@12).

Secondary objectives are to assess the efficacy by recurrence-free surviaval (RFS) and overall survival (OS); to assess safety of the combination treatments (AEs, impact on liver function, use of subsequent therapies); to assess quality of life (QoL).

Exploratory objective is to perform correlation analysis between selected molecular parameters and clinical data to identify molecular biomarkers predictive for RFS and OS.

Patients will be stratified according to the tumor site (ICC vs. ECC vs. gallbladder) and resection status (R0 vs. R1).

In this pilot trial phase, a pick the winner design is applied to determine wether treatment with durvalumab and tremelimumab in combination with or without capecitabine is more promising.

In the initial pilot phase, 40 patients with histologically proven and curatively resected biliary tract cancer (intrahepatic, hilar or distal CCA as well gallbladder carcinoma) without metastatic disease, will be enrolled in a 1:1 randomized design (i.e. 20 patients per Arm).

Patients will be recruited from up to 15 sites and patients withdrawn from the trial will not be replaced.

Treatment consists of durvalumab and tremelimumab with or without capecitabine.

Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer

A Phase II Study of Immunotherapy With Durvalumab and Tremelimumab in Combination With Capecitabine or Without Capecitabine in Adjuvant Situation for Biliary Tract Cancer

Recurrence free survival at 12 months (RFS@12) will be defined as the proportion of allocated subjects without any recurrence/progression and alive at 12 months after the date of treatment allocation.

Recurrence-free survival (RFS) will be determined as time from the date of treatment allocation to the date of (1) any recurrence/progression (local or regional \[including invasive ipsilateral tumor and invasive locoregional tumor\], or distant) or (2) death due to any cause.

Overall survival (OS) will be determined as time from the date of treatment allocation to the date of death due to any cause. A subject who has not died will be censored at last known date alive.

Safety assessments will include adverse events. All observed toxicities and side effects will be graded according to NCI CTCAE v5.0 for all patients and the degree of association of each with the study treatment assessed and summarized. Treatment related serious adverse events rate (SAE) will be determined.

QoL will be assessed by the EORTC QLQ-C30 questionnaire in itsmost current version.

The QoL analyses will include QoL mean values, QoL response and time to symptom deterioration (TTSD) defined as the time interval between randomization and the first decrease by ≥ 10-points. All randomly assigned patients with a baseline and at least one post-baseline assessment will be included in TTSD analyses. Patients without observed deterioration will be censored at the time of their last QoL assessment.

EORTC QLQ C30 (30 questions) regarding body fitness, daily routines, restrictions at work and hobby, appetite, fatigue, cough, breathlessness, pain, tiredness, body conditions, state of health and Quality of life.

QoL will be assessed by the EORTC QLQ-BIL21 questionnaire in its most current version.

The QoL analyses will include QoL mean values, QoL response and time to symptom deterioration (TTSD) defined as the time interval between randomization and the first decrease by ≥ 10-points. All randomly assigned patients with a baseline and at least one post-baseline assessment will be included in TTSD analyses. Patients without observed deterioration will be censored at the time of their last QoL assessment.

EORTC QLQ BIL21 (21 questions) regarding eating habits, body fitness, fatigue, pain, tiredness and mental health.

QoL will be assessed by the QoL EQ-5D-5L questionnaire in its most current version.

The QoL analyses will include QoL mean values, QoL response and time to symptom deterioration (TTSD) defined as the time interval between randomization and the first decrease by ≥ 10-points. All randomly assigned patients with a baseline and at least one post-baseline assessment will be included in TTSD analyses. Patients without observed deterioration will be censored at the time of their last QoL assessment.

EQ 5D-5L (6 questions) about mobility, sorrows, daily routine, pain, anxiety and health perception.

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

EUS-CDS

Jeska Fritzsche

Jeska Fritzsche, MD

A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to reduce stent dysfunction.

EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction

EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS

Recurrent jaundice after initial clinical success, ongoing jaundice in combination with remaining dilatation of the bile ducts, or cholangitis.

Successful creation of a choledochoduodenostomy using a LAMS

Successful placement of FCSEMS through LAMS.

50% decrease or normalization of bilirubin level within 14 days of the procedure. Presumed persistant hepatic secretory failure with ongoing jaundice but decreased diameter of the bile ducts and decrease of ALT, alkaline phosphatase and gamma-glutamyl transpeptidase is not considered clinical failure of the intervention.

Is measured from introduction of endoscope in the patient until removal of endoscope after completion of the procedure. In case a fine needle aspiration (FNA) or biopsy (FNB) needs to be taken from the primary tumour to confirm malignancy, time is measured after completion of this procedure.

Are defined as any probably or definitely procedure- or admission related adverse event occurring after EUS-CDS. Severity will be recorded and graded NL81840.029.22 version 1.1 08-08-2022 SCORPION-II-pilot study 23 of 45 (mild, moderate, severe or fatal) according to the ASGE lexicon.(23) Common or expected AEs are defined according to the ASGE lexicon (including the following categories: cardiovascular, pulmonary, thromboembolic, perforation, bleeding, infection, pain).

Is calculated from the moment of stent insertion until stent dysfunction for which a new procedure is required.

Is defined as any unplanned intervention (endoscopic, intervention radiology or surgical) for an adverse event, persistent jaundice or recurrent obstructive symptoms, that is needed after EUS-CDS.

Is defined as the number of days after EUS-CDS until initiation of chemotherapy or surgery.

Is defined as the number of days patient was admitted within the first 30 days after the procedure.

Is defined by the number of days after EUS-CDS until death. The cause of death will be registered

Are defined as the intramural costs that were involved with EUS-CDS, collected from the electronic hospital records and linked to the Dutch unit costs

VU University of Amsterdam

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Principal Investigator

Whipple or pylorus preserving pancreatoduodenectomy following minimally invasive approach (laparoscopic or robotic). Hybrid (hand assisted) precedures will be included in the minimally invasive cohort.

Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach.

Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques

Minimally invasive pancreatoduodenectomy

Moh'd Abu Hilal, MD, PhD

Outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. This is an international multicenter propensity score matched cohort study including patients after MIPD or OPD for dCCA. Primary outcomes included overall survival (OS) and disease-free interval (DFI).

This study is an international multicenter propensity score matched cohort study using the database of the International Study Group on non-pancreatic periAmpullary CAncer, the ISGACA consortium (www.isgaca.com), including all patients who underwent a pancreatoduodenectomy for non-pancreatic periampullary cancer. Data will be retrospectively collected. To minimize differences between groups, all the participating centers perform both OPD and MIPD and all centers meet the Miami guideline minimum volume of at least 20 MIPD per year. This study is approved by all the locals Ethical Committees (approval number from the promoting center, Comitato etico di Brescia, NP 5318 - 01.06.2022) and it will be performed according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE guideline and checklist), and the Declaration of Helsinki.

Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

Surgical and Oncological Outcome After Minimally Invasive and Open Pancreatoduodenectomy for Distal Cholangiocarcinoma: an International Propensity Score Cohort Study

Upon reasonable request it would be possible to share data.

Time-to-event data, months + occurrence of event (death or recurrence)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer	NCT05239169	Biliary Tract C... Intrahepatic Ch... Hilar Cholangio... Distal Cholangi... Gall Bladder Ca...	Durvalumab Tremelimumab Capecitabine	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction	NCT05595122	Biliary Obstruc... Pancreas Neopla... Distal Cholangi...	EUS-CDS	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma	NCT05478889	Distal Cholangi...	Minimally invas...	18 Years -	Fondazione Poliambulanza Istituto Ospedaliero
Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma	NCT05478889	Distal Cholangi...	Minimally invas...	18 Years -	Fondazione Poliambulanza Istituto Ospedaliero
Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer	NCT05239169	Biliary Tract C... Intrahepatic Ch... Hilar Cholangio... Distal Cholangi... Gall Bladder Ca...	Durvalumab Tremelimumab Capecitabine	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction	NCT05595122	Biliary Obstruc... Pancreas Neopla... Distal Cholangi...	EUS-CDS	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction	NCT05595122	Biliary Obstruc... Pancreas Neopla... Distal Cholangi...	EUS-CDS	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer	NCT05239169	Biliary Tract C... Intrahepatic Ch... Hilar Cholangio... Distal Cholangi... Gall Bladder Ca...	Durvalumab Tremelimumab Capecitabine	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Spots Global Cancer Trial Database for distal cholangiocarcinoma