Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Constriction, Pathologic

Jaundice

Hyperbilirubinemia

Skin Manifestations

Pancreatic Cancer

Bile Duct Cancer

The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available.

Biliary drainage before surgery or chemotherapy is a common practice in patients with neoplastic stenosis of the common bile duct, often required by the presence of clinical conditions such as the onset of cholangitis or severe jaundice.

The endoscopic approach has now been identified by the literature as the preferential drainage route, due to a lower incidence of adverse effects, liver or intraperitoneal metastases and lower costs associated with this technique compared to percutaneous drainage.

The latest guidelines from the European Society of Gastrointestinal Endoscopy recommend the placement of a 10 mm diameter self-expandable metal stent (SEMS) as the first choice for endoscopic drainage in patients with extra-hepatic biliary stenosis of neoplastic origin. Compared to plastic stents, SEMS placement is associated with a lower risk of developing stent dysfunction and/or cholangitis, lower risk of reintervention, and better patient survival.

However, among the various types of metal stents available, to date there is no agreement on which type is the most suitable, as data on efficacy and post-interventional morbidity and mortality of the fully or partially covered and uncovered metal stents are contradictory.

The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available.

Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)

Rate of resolution of obstructive jaundice in short and long term (i.e. maintenance of patency and/or the need for reintervention) of the different types of biliary stent placed in patients with neoplastic stenosis of the common bile duct

Rate of periprocedural complications (i.e. bleeding, pancreatitis, cholecystitis) after biliary stent placement

Rate of stent disfunction requiring an additional endoscopic procedure

Rate of biliary cannulation and successful stent placement

Azienda Unità Sanitaria Locale della Romagna

Chief of Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals

Stomach Neoplasms

Duodenal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Bile Duct Neoplasms

Gastrointestinal Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Duodenal Diseases

Intestinal Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Irinotecan

Pancrelipase

Pancreatin

Topoisomerase I Inhibitors

Enzyme Inhibitors

irinotecan

radiation therapy

Syma Iqbal, M.D.

This study is for people with advanced cancer of the digestive tract and cancer that cannot be completely removed by surgery. Radiation therapy is commonly used in the treatment of these types of cancer in combination with a chemotherapy drug, called 5-fluorouracil (5-FU). In this study, doctors will administer the standard dose of radiation therapy in combination with an investigational chemotherapy drug, called irinotecan. Irinotecan can decrease the size of tumors and also appears to increase the effectiveness of radiation. The purpose of this study is to determine the highest dose of irinotecan that can be given safely in combination with radiation therapy, and to determine the side effects when these two treatments are given together. Irinotecan is approved by the Food and Drug Administration (FDA) for the treatment of colon cancer, but is not approved for cancers of the digestive tract. However, the FDA is allowing its use in this research study.

Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

University of Southern California

Klatskin Tumor

Biliary Tract Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Amino Acids

Antibodies

Antibodies, Monoclonal

Lenvatinib

Angiogenesis Inhibitors

Immunoglobulins

Endothelial Growth Factors

Mitogens

Protein Kinase Inhibitors

Tyrosine

Toripalimab (Shanghai Junshi Biosciences Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.

Lenvatinib is a novel angiogenesis inhibitor which targets multiple tyrosine kinases， including vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT.

Toripalimab 240mg, every 3 weeks, intravenous infused, day 1, 6 weeks a cycle.

Lenvatinib 8mg (weight\<60kg) or 12mg (weight≥60kg), once a day, orally, day 2, 6 weeks a cycle. Dose reduction to 4mg/d or dose termination is allowed according to adverse events.

Number of cycle: until progression or unacceptable toxicity events develop.

Toripalimab plus Lenvatinib

Xiaobo Yang, MD

Haitao Zhao, MD

Xiaobo Yang

The investigators design a phase II clinical study to explore the efficacy and safety of toripalimab plus lenvatinib as a second-line treatment in patients with advanced biliary tract cancers and to analyze potential biomarkers of therapeutic response.

This phase II trial is a single-arm, non-randomized and single-center clinical study.

It is estimated that 44 patients who met the study criteria will be enrolled in 2 years and treated with toripalimab plus lenvatinib in PUMCH. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including overall survival and time to progression, until disease progression or death. Interim analysis and final analysis will be conducted when collecting data from 20 and 44 subjects, respectively in this trial. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response.

Study Type: Interventional.

Masking: Open Label.

Patients are confirmed with advanced biliary tract cancers by imaging and histological examination and meet with the inclusive criteria, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct cancer and gallbladder cancer.

Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers

Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers: a Single-arm, Non-randomized, Single-center Clinical Trial and Biomarker Study

Any biomarker related with efficacy and safety.

Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.

the incidence rate of any adverse events related with treatment drugs and details include adverse events type, frequency and severity.

Duration from the date of initial treatment to the date of death due to any cause.

A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.

Proportion of patients with stable disease status more than 4 months.

Proportion of patients achieved complete response and partial response for more than 6 months.

Portion of patients who do not experience disease progression (defined by RECIST 1.1) or death of any cause after treated with toripalimab plus lenvatinib for 3 months and 6 months, respectively.

Portion of patients who die of any cause after treated with toripalimab plus lenvatinib at 6 months and 1 year, respectively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)	NCT05395013	Common Bile Duc... Jaundice; Malig...		18 Years -	Azienda Unità Sanitaria Locale della Romagna
Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers	NCT00183846	Pancreatic Canc... Gastric Cancer Duodenum Cancer Bile Duct Cance...	irinotecan radiation thera...	18 Years -	University of Southern California
Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)	NCT05395013	Common Bile Duc... Jaundice; Malig...		18 Years -	Azienda Unità Sanitaria Locale della Romagna
Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers	NCT04211168	Advanced Biliar...	Toripalimab plu...	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for common bile duct cancer