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Cholangiocarcinoma clinical trials

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NCT ID: NCT05411133 Recruiting - Pancreatic Cancer Clinical Trials

Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients

Start date: May 30, 2022
Phase: Phase 1
Study type: Interventional

This study aims to find out: 1. The tolerability of Cabotamig (ARB202) in adults with advanced solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker. 2. To find out how study drug is broken down in the body 3. To know the effects of the study drug on the tumor.

NCT ID: NCT05404503 Recruiting - Clinical trials for Incidence of Cholangiocarcinoma on Choledochal Cysts

Analysis of the Incidence of Cholangiocarcinoma on Choledochal Cyst in a Western Center

QuiCo
Start date: October 2022
Phase:
Study type: Observational

Choledochal cysts are congenital cystic dilatations of the intra and/or extrahepatic bile duct. They have been considered a rare entity of the child population. Globally, they account for 1% of all biliary pathology benign, with a clearly higher incidence in Asian countries (1/5,000 in China, 1/1,000 in Japan, compared to 1/100,000-150,000 in Western countries). However, the number of adults diagnosed in recent years has increased by up to 70% due to improvements in imaging tests. Currently, the common bile duct malformation is considered a premalignant entity: although the data are not very precise, it is estimated that between 2.6% and 26% of patients diagnosed choledochal cyst, will develop cholangiocarcinoma. In this sense, we must bear in mind that most of the published literature is of Asian origin, where the rate of cholangiocarcinoma is 0.1-71/100,000 compared to 0.1-1.8/100,000 in Europe or 0.6-1/100,000 in the USA. The most used classification to differentiate the types of cysts is that of Todani. Following this classification, we would find a higher rate of malignancy on types I and IV. The recommendations found in the literature refer to the need for surgical intervention for choledochal cysts due to their high rate of malignancy. These recommendations are based on studies conducted in a symptomatic Asian population. We do not usually find in therapeutic algorithms the inclusion of various factors that could be involved in the development of malignancy such as episodes of cholangitis, presence of anomaly in the pancreatobiliary junction, presence of lithiasis in cystic dilatation, etc. Some surveys carried out among the scientific population reflect a lack of consensus on its management: in the same clinical situation, different surgery units specialized in hepatobiliary-pancreatic pathology would act in the opposite way (specifically surgical versus conservative treatment). Bile duct resection is not without complications, both short-term and long-term. Therefore, the patient's symptoms, age or comorbidities can play an important role in decision-making in the treatment of this pathology. This nationwide multicenter retrospective observational study aims to determine the clinical situation of this rare pathology in a Western environment. A retrospective analysis of patients diagnosed with choledochal cyst in the period between 2000 and 2020 is proposed. Demographic variables, risk factors for cholangiocarcinoma, symptoms associated with the cyst and its characteristics, diagnostic method, type of treatment, complications will be analyzed. Malignancy, time, and follow-up method will also be discussed. This study will attempt to answer questions about the incidence of choledochal cysts in our environment, their association with cholangiocarcinoma, the associated morbidity and mortality, as well as the therapeutic and follow-up attitudes adopted in the face of this rare pathology.

NCT ID: NCT05400902 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

HAIC Combined With Sintilimab and Bevacizumab for Unresectable Intrahepatic Cholangiocarcinoma

Start date: May 31, 2023
Phase: Phase 2
Study type: Interventional

Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with sintilimab and bevacizumabin the treatment of unresectable ICC.

NCT ID: NCT05348811 Recruiting - Cholangiocarcinoma Clinical Trials

HAIC Combined With Donafenib and Sintilimab for Unresectable ICC

Start date: December 28, 2022
Phase: Phase 2
Study type: Interventional

To evaluate the safety and tolerability of HAIC combined with donafenib and sintilimab in first-line treatment of unresectable ICC.

NCT ID: NCT05346484 Recruiting - Solid Tumor Clinical Trials

A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

MAST
Start date: May 17, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab in patients with metastatic or advanced solid tumors.

NCT ID: NCT05328167 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Contrast-Enhanced Ultrasound for the Prediction of Bile Duct Cancer Response to Radioembolization Treatment

Start date: December 14, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial tests whether contrast-enhanced ultrasound can predict the response of bile duct cancer to targeted radiotherapy (radioembolization treatment). Contrast-enhanced ultrasound uses gas microbubbles that may provide enhancement on ultrasound. It is also possible to pop these microbubbles using ultrasound imaging. Tumors that experience popping of these microbubbles may be easier to kill with radiotherapies. Therefore, this trial may also help doctors see if ultrasound-triggered microbubble popping can improve bile duct cancer response to radiotherapy. Another purpose of this trial is to test if the pressure inside the tumor estimated through ultrasound can be used to predict the tumor response to radiotherapy.

NCT ID: NCT05327907 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Establishment of Scoring Model for Early and Differential Diagnosis of Intrahepatic Cholangiocarcinoma

Start date: November 22, 2020
Phase:
Study type: Observational

The purpose of this study is to develop and validate a radiological nomogram including radiological characteristics, clinical risk factors, and medical history. And we aim to establish a noninvasive method for the diagnosis of intrahepatic cholangiocarcinoma (ICC), and to construct a differential diagnosis model for ICC and hepatocellular carcinoma (HCC) with higher sensitivity and accuracy.

NCT ID: NCT05290116 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

HAIC Combined With Tislelizumab and Apatinib for Unresectable Intrahepatic Cholangiocarcinoma

Start date: July 21, 2022
Phase: Phase 2
Study type: Interventional

Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with tislelizumab and apatinib in the treatment of unresectable ICC.

NCT ID: NCT05286814 Recruiting - Colorectal Cancer Clinical Trials

M9241 in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer or Intrahepatic Cholangiocarcinoma

Start date: October 24, 2022
Phase: Phase 2
Study type: Interventional

Background: One way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug M9241 can improve the treatment. The drug triggers the immune system to fight cancer.<TAB> Objective: To see if treatment with HAIPs to deliver liver-directed chemotherapy in combination with M9241 is effective for certain cancers. Eligibility: People aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver. Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test (if needed) Tumor biopsy (if needed) Electrocardiogram Computed tomography (CT) scans Participants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen. Participants will have chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. M9241 will be injected under the skin every 4 weeks. They will get systemic chemotherapy through an IV or mediport every 2 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects. Participants will have 2 study visits each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests. Participants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.

NCT ID: NCT05285358 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases

Start date: September 19, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases). PIPAC involves the administration of intraperitoneal chemotherapy (anticancer drugs given directly to the lining of the abdomen). PIPAC uses a nebulizer (a device that turns liquids into a fine mist) which is connected to a high-pressure injector and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and insert a camera and other instruments into the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen), which results in the drug reaching more of the tissue as well as reaching deeper into the tissue, which reduces the amount of chemotherapy that needs to be used and potentially reduces side effect. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nab-paclitaxel via PIPAC in combination with standard of care gemcitabine and cisplatin may reduce side effects and make this chemotherapy regimen more tolerable in patients with biliary tract cancer that has spread to the spread to the peritoneum.