Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Neoplasm Metastasis

Breast Neoplasms

Liver Neoplasms

Breast Diseases

Skin Diseases

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Capecitabine

Trastuzumab

Oxaliplatin

Liver Extracts

Antimetabolites

Antineoplastic Agents, Immunological

Oxaliplatin intrahepatic capecitabine + trastuzumab systemic

oxaliplatin, capecitabine, trastuzumab

Dorte Nielsen, Professor

This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer.

Only patients without extrahepatic disease are included.

Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Capecitabine in Patient With Non-resectable Liver Metastases From Breast Cancer. A Phase II Trial

Number of patients with complete or partial response in the liver (RECIST version 1.1)Only patients with measurable disease are included in the protocol. Response rate number of patients with CR + PR divided with total number

Time from treatment start to progression of disease or death of any cause.

Total number of patients receiving RF treatment or surgical treatment

All patients in intent-to-treat population , calculated from start of treatment to death of any cause

All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used.

Dorte Nielsen

Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital.

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Alejandro Mejia, MD

The use of Radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. Methodist Dallas Medical Center has a large volume of IR procedures with Radioembolization and the investigators feel it is imperative to understand the outcomes, risks and benefits of the therapy in order to formulate recommendation to other centers.

A retrospective chart review of patients who have the diagnosis of intrahepatic cholangiocarcinoma. Only patients treated at MDMC are included and data will be obtained from Meditech and Epic. A non-identified database of cases with the diagnosis of intrahepatic cholangiocarcinoma already treated with radiospheres will be created and compared with cases treated by other means.

Intrahepatic cholangiocarcinoma is the second most common primary malignancy of the liver. The standard therapy has been resection but many cases are not resectable due to comorbidities or other poor surgical candidacy factors. Most of these patients end up getting chemotherapy which can be toxic and sometimes poorly tolerated. Intrarterial glass or resin radioembolization has been used and published from only 3 centers in the medical literature and it has been shown to be a reasonable alternative to the above options. At MDMC, this therapy has been used effectively and it is important to describe the investigator's experience.

Treat Primary and Metastatic Liver Tumors

Radioembolization to Treat Primary and Metastatic Liver Tumors

Methodist Health System

Neoplasms, Second Primary

Anti-Infective Agents

Antibodies

Gemcitabine

Immunoglobulins

Mitomycins

Mitomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Intrahepatic treatment, where all standard treatments have been used

Mitomycin + Gemcitabine

Ole Larsen, ph.d., MD

Finn O Larsen, M.D., Ph.D

The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.

Two regiment are used: N.B. The two regiments will be reported separately

1. Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.
2. FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added.

Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor

Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors

Copenhagen University Hospital at Herlev

Biliary Tract Neoplasms

Biliary Tract Diseases

Biliary Tract Cancer

Cisplatin

725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle

1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle

IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes

NUC-1031

IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert

IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol

Jennifer Knox, MD

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.

The primary hypotheses are:

* The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care
* The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care

1:1 randomization model to either Arm A or Arm B

Imaging scans will be assessed by blinded independent review according to RECIST v1.1

Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer

Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where" CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were also randomized ≥28 weeks before the data cut-off (ITTMD28). Patients were to receive a confirmatory scan 28-42 days after response is first observed.

The median time, in months, from the date of randomization to the date of death from any cause. For patients who were alive at the time of a data cut-off or were permanently lost to follow up, duration of OS was censored at the date at which they were last known to be alive.

NuCana plc

All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.

725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle

NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes

Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol

A - NUC-1031 and Cisplatin

1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle

Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert

Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol

B - Gemcitabine and Cisplatin

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Primary tumour location

Extent of disease

Patients with measurable disease as determined by RECIST v1.1 criteria:

Tumour lesions must be accurately measured in at least one dimension (longest diameter in the plane of measurement to be recorded) with a minimum size of:

* 10 mm by CT or MRI scan (CT/MRI scan slice thickness/interval no greater than 5 mm)
* 10-mm caliper measurement by clinical examination

To be considered pathologically enlarged and measurable, a lymph node must be ≥15 mm in the short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm).

Measurable disease

The ECOG score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The score runs from 0 to 5, with 0 denoting perfect health and 5 death. Patients with scores of 0 or 1 were eligible for this study:

0 - Asymptomatic. Fully active, able to carry on all predisease activities without restriction

1 - Symptomatic but completely ambulatory. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).

ECOG performance status

At Interim Analysis 1, the futility boundary for OS was crossed and the study was closed on 02 Mar 2022. Following study closure, data from the 05 April 2022 final data cut-off (30 day follow-up post the last patient last visit) were analysed. In general, the analyses performed on this final database were those that were scheduled to take place at Interim Analysis 2. However, any p-values or CIs obtained are only viewed as descriptive as the study was stopped for futility.

Medical and Scientific Affairs Department

Intent-to-treat with measurable disease at baseline randomized ≥28 weeks before the data cut-off (ITTMD28)

Objective Response Rate (ORR)

Overall Survival (OS)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Infections

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Stomach Neoplasms

Triple Negative Breast Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Renal Cell

Microsatellite Instability

Squamous Cell Carcinoma of Head and Neck

Carcinoma, Basal Cell

Mesothelioma

Mesothelioma, Malignant

Skin Neoplasms

Melanoma, Cutaneous Malignant

Carcinoma, Merkel Cell

Fallopian Tube Neoplasms

Endometrial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neoplasms, Squamous Cell

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Urologic Neoplasms

Urologic Diseases

Male Urogenital Diseases

Kidney Neoplasms

Kidney Diseases

Head and Neck Neoplasms

Adenoma

Neoplasms, Mesothelial

Fallopian Tube Diseases

Neoplasms, Basal Cell

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Fallopian Tube Cancer

Malignant Mesothelioma

Merkel Cell Carcinoma

Acral Lentiginous Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Analgesics

Immune Checkpoint Inhibitors

Pembrolizumab

Immunomodulating Agents

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer	NCT01387373	Metastatic Brea... Liver Metastase...	oxaliplatin, ca...	18 Years -	Herlev Hospital
Treat Primary and Metastatic Liver Tumors	NCT05240040	Intrahepatic Ch... Liver Tumor Metastatic Canc... Metastatic Live...		18 Years -	Methodist Health System
Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor	NCT01511146	Liver Metastasi...	Oxaliplatin Mitomycin + Gem...	18 Years -	Copenhagen University Hospital at Herlev
Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer	NCT04163900	Biliary Tract C...	NUC-1031 Gemcitabine Cisplatin	18 Years -	NuCana plc
A Beta-only IL-2 ImmunoTherapY Study	NCT05086692	Advanced Solid ... Unresectable So... Clear Cell Rena... Triple Negative... Non-Small Cell ... Non-Small Cell ... Colorectal Canc... Gastric Cancer Cervical Cancer Basal Cell Carc... Bladder Cancer Merkel Cell Car... Squamous Cell C... Cutaneous Squam... Pleural Mesothe... Esophageal Canc... Endometrial Car... Solid Tumor Solid Tumor, Ad... MSI-H Solid Mal... Cancer With A H... Epithelial Ovar... Primary Periton... Gastroesophagea... Acral Melanoma Mucosal Melanom... Cutaneous Melan... DMMR Solid Mali... Fallopian Tube ... Ovarian Cancer MSI-H Cancer DMMR Cancer Pancreas Adenoc... Skin Cancer	MDNA11 Pembrolizumab	18 Years -	Medicenna Therapeutics, Inc.
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer	NCT00753675	Biliary Tract C... Gallbladder Can... Cancer Of The E... Ampullary Carci...	ZD6474, Vandeta... ZD6474, Vandeta... Gemcitabine Placebo matchin...	18 Years -	Sanofi
Treat Primary and Metastatic Liver Tumors	NCT05240040	Intrahepatic Ch... Liver Tumor Metastatic Canc... Metastatic Live...		18 Years -	Methodist Health System
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer	NCT00753675	Biliary Tract C... Gallbladder Can... Cancer Of The E... Ampullary Carci...	ZD6474, Vandeta... ZD6474, Vandeta... Gemcitabine Placebo matchin...	18 Years -	Sanofi

Spots Global Cancer Trial Database for intrahepatic

Every month we try and update this database with for intrahepatic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.