Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gallbladder Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Pancreatic Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

All patients will receive concurrent chemoradiation. Chemotherapy will consist of Inj. Gemcitabine 300mg/mt2 weekly throughout the course of Radiotherapy. Radiotherapy will be delivered using Tomotherapy to a dose of 57Gy/25# over 5 weeks

Radiotherapy 57-60 Gy in 25 fraction to PTV boost (SIBV - simultaneous integrated Boost volume) (2.3-2.4Gy/Fr)

Concurrent chemotherapy Weekly concurrent CT schedule: Inj Gemcitabine 300 mg/m2 weekly during RT.

Surgery: All patients will be evaluated for surgery in the joint clinic by surgeons and other treating physicians at 6-8 weeks post CT-RT. PET CT Scan will be used as the imaging modality. Patients suitable for R0 resection will be planned for surgery. Inoperable patients will be treated with palliative chemotherapy.

Tomotherapy

Reena Engineer, MD

SUMMARY

PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase II study

SPECIFIC OBJECTIVES:

Primary To assess the radiological response by dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.

Secondary

1. To assess the resectability rate with microscopic negative margin (R0).
2. To assess the acute and late toxicities (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
3. To study the locoregional control in the patients undergoing R0 resection
4. To study overall survival

DESIGN: Phase II study

STUDY POPULATION: All patients of age \>18 years years diagnosed with non metastatic locally advanced inoperable gall bladder and pancreatic cancer

STUDY SIZE: 60 patients

METHODOLOGY: Sixty cases will be screened and taken for study if eligible after taking the informed consent.

Patients will receive radiotherapy using Tomotherapy based IMRT with concurrent chemotherapy Gemcitabine weekly. The response will evaluated at 6 weeks post chemoradiation and if operable will undergo surgery, if still inoperable or metastatic will receive palliative chemotherapy.

PROJECT PERIOD:

Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of data : 1 year

STUDY SITE: Tata memorial centre

In both gall bladder and pancreatic cancer surgery is the main stay of treatment, but majority of these tumors are inoperable by virtue of adjacent organ infiltration. In this study, inoperable gallbladder and pancreatic cancer patients will be treated with high precision radiotherapy using Tomotherapy delivering higher dose of radiation along with chemotherapy. It is expected that this high dose precise radiotherapy along with chemotherapy will lead to good symptom relief and make some of these tumors operable.

Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study

Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability

All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT

All patients will be jointly evaluated for surgery 6 weeks post chemoradiation

At the median follow up of 3 years the 5 year overall survival rate would be assesed

Tata Memorial Hospital

Professor

Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

Cholangiocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Esophageal Cancer

Bile Duct Cancer

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

Micronutrients

Hematinics

Vitamins

Antibodies

Capecitabine

Bevacizumab

Leucovorin

Fluorouracil

Levoleucovorin

Cisplatin

Immunomodulating Agents

Oxaliplatin

Folic Acid

Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

ZW25 plus fluorouracil (5-FU) and cisplatin

ZW25 plus 5-FU, leucovorin, and oxaliplatin

ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab

* Part 1: administered IV at dose levels and schedules determined by the Safety Monitoring Committee (SMC)
* Part 2: RD identified in Part 1

ZW25 (Zanidatamab)

Phillip Garfin, MD, PhD

This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).

Part 1 of the study will first evaluate the safety and tolerability of ZW25 plus standard first-line combination chemotherapy (XELOX, FP, or mFOLFOX6 for GEA; mFOLFOX6 with or without bevacizumab for CRC; and CisGem for BTC) and will confirm the recommended dosage (RD) of ZW25 when administered in combination with each of these multi-agent chemotherapy regimens. Then, Part 2 of the study will evaluate the anti-tumor activity of ZW25 plus combination chemotherapy in HER2-expressing GEA, BTC, and CRC.

A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC)

Number of participants who experienced a DLT. DLTs include adverse events considered to be related to study treatment, including the evaluated dose level of ZW25, any component or combination of the components of a chemotherapy regimen, or the combination of ZW25 plus a chemotherapy regimen.

Number of participants who experienced an adverse event

Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology and chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Number of participants who achieved a best response of either CR or PR during treatment per RECIST 1.1

Number of participants who achieved a best response of CR, PR, or stable disease (SD) during treatment per RECIST 1.1

Median duration of response (in months) and range (minimum, maximum)

Number of participants with SD for ≥ 24 weeks or a confirmed, best overall response of CR or PR per RECIST 1.1

Median progression-free survival (in months) and range (minimum, maximum)

Median overall survival (in months) and range (minimum, maximum)

Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology and chemistry. Grades are defined using National Cancer Institute's CTCAE, version 5.0.

Jazz Pharmaceuticals

Symptoms and General Pathology

Neoplasm Metastasis

Bile Duct Diseases

Bile Duct Neoplasms

Liver Extracts

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.

Regorafenib

Richard Kim, M.D.

The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.

Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Multi Institutional Phase II Trial of Single Agent Regorafenib in Refractory Advanced Biliary Cancers

OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.

DCR defined as Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD). CR: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below); No new lesions. PR: Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of nonmeasurable disease; No new lesions. SD: Does not qualify for CR, PR, Progression or Symptomatic Deterioration.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

Progression - One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site.

Bayer

H. Lee Moffitt Cancer Center and Research Institute

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.

Regorafenib Monotherapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Richard Kim, MD

Patients that were evaluable for efficacy

Overall Survival (OS) at 6 Months

Disease Control Response (DCR)

Progression Free Survival (PFS)

Overall Study

Constriction, Pathologic

Gastrointestinal Agents

Pancrelipase

Pancreatin

ERCP with or without cholangiopancreatoscopy will be performed by the endoscopist as clinically indicated. If findings at ERCP and/or prior imaging studies and/or clinical assessment suggest possible malignancy and/or an indeterminate biliary or pancreatic pathology Cellvizio probe-based endomicroscopy will be performed during ERCP.

Probe-based confocal laser endomicroscopy

Yang Chen, MD, FACP, FACG

This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

This is a registry study to collect high quality longitudinal data from patients with suspected or indeterminate pancreaticobiliary pathology who are undergoing an ERCP with Cellvizio probe-based endomicroscopy procedure, with or without supplemental direct cholangiopancreatoscopy. The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone.

Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary and/or pancreatic duct lesions will be compared for the combination of endomicroscopy and ERCP imaging and ERCP alone. These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting various safety and technical performance parameters.

A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers

Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database

Cellvizio Inc.

Emissary International LLC

Mauna Kea Technologies

Anne Osdoit / Clinical Affairs Manager

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

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

Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.

Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.

Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.

Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.

Copanlisib

Richard D. Kim, M.D.

The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.

Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

Phase II Study of Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

PFS at six months. Response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). PFS will be calculated from study entry to documented disease progression, death from any cause, or date of last follow-up, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

Complete Response + Partial Response according to RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.

Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.

Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.

Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.

Combination Therapy

All participants that received at least one dose of study drug

Richard Kim, MD, Principal Investigator

Partial Response

Stable Disease

Number of participants evaluable for response

Response Rate

Overall Survival (OS)

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.

Gemcitabine: 800 mg/m\^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.

20 mg /m\^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.

Ghassan Abou-Alfa, MD

The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers.

Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. We are looking to improve treatment results. We will attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan. Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the cancer cells grow and divide. This study will help answer the question of whether sorafenib is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.

This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile duct and gallbladder cancers.

Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy

A Phase II Study of Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naïve to Systemic Therapy

Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.

Memorial Sloan Kettering Cancer Center

This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.

Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:

Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.

Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.

Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers	NCT01118897	Pancreatic Neop... Malignant Neopl...	Tomotherapy	18 Years - 75 Years	Tata Memorial Hospital
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer	NCT03929666	HER2-expressing...	ZW25 (Zanidatam... Capecitabine Cisplatin Fluorouracil Leucovorin Oxaliplatin Bevacizumab Gemcitabine	18 Years -	Jazz Pharmaceuticals
Single Agent Regorafenib in Refractory Advanced Biliary Cancers	NCT02115542	Cancer of the B...	Regorafenib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer	NCT03929666	HER2-expressing...	ZW25 (Zanidatam... Capecitabine Cisplatin Fluorouracil Leucovorin Oxaliplatin Bevacizumab Gemcitabine	18 Years -	Jazz Pharmaceuticals
A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers	NCT00779688	Pancreatic Canc... Bile Duct Cance...	Probe-based con...	18 Years -	Mauna Kea Technologies
Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma	NCT02631590	Biliary Carcino... Gall Bladder Ca... Cholangiocarcin... Gastrointestina...	Cisplatin Gemcitabine Copanlisib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy	NCT00919061	Extrahepatic Bi... Gallbladder Can...	Gemcitabine Cisplatin Sorafenib	18 Years -	Memorial Sloan Kettering Cancer Center
Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy	NCT00919061	Extrahepatic Bi... Gallbladder Can...	Gemcitabine Cisplatin Sorafenib	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for gall bladder

Every month we try and update this database with for gall bladder 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.