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Gallbladder Neoplasms clinical trials

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NCT ID: NCT05253053 Recruiting - Prostate Cancer Clinical Trials

To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors

Start date: April 13, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors (solid tumor, BTC and TNBC).

NCT ID: NCT05237193 Recruiting - Gallbladder Cancer Clinical Trials

A Prospective Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-up

Start date: September 3, 2021
Phase:
Study type: Observational

Chromosomal instability (CIN) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CIN is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CIN of the DNA extracted from bile tract exfoliated cells in bile samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with malignant biliary obstruction, including biliary tract cancer (BTC), pancreatic head carcinoma. CIN can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. The investigators here intend to study whether a new method named Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CIN thus helping diagnose malignant biliary obstruction and assessing follow-up.

NCT ID: NCT05184400 Recruiting - Cholangiocarcinoma Clinical Trials

Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer

CHOCA
Start date: January 1, 2015
Phase:
Study type: Observational

No validated biomarkers exist that can identify patients with biliary tract cancer at an early stage or predict treatment outcomes. The objective of the present study is to find diagnostic, prognostic and predictive biomarkers.

NCT ID: NCT05102110 Recruiting - Pancreatic Cancer Clinical Trials

Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer.

ORI-EGI-03
Start date: December 1, 2021
Phase:
Study type: Observational

The aim of the study is to assess the feasibility of genomic and epigenetic analysis of rectal mucus to detect non-colorectal cancers of the aero- digestive tract using samples collected by the OriColâ„¢ Sampling Device. The primary objective of the study is to assess whether significant changes in DNA mutation and methylation associated with Non-colorectal cancers of the Aero- digestive Tract (NCRCADT) can be detected in rectal mucus as shed cells and cell-free DNA (cfDNA) pass through the gut and theoretically can be collected from rectal mucus. Secondary objectives will assess the participant acceptability of the OriColâ„¢ Sampling Device for Upper GI and Lung Pathology as well as contributing to a genomic library collating information about rectal mucus.

NCT ID: NCT05007106 Recruiting - Clinical trials for Hepatocellular Carcinoma

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

Start date: September 16, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

NCT ID: NCT05000294 Recruiting - Breast Cancer Clinical Trials

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Start date: December 7, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.

NCT ID: NCT04907643 Recruiting - Rectal Cancer Clinical Trials

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

Start date: October 5, 2021
Phase: N/A
Study type: Interventional

Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.

NCT ID: NCT04871321 Recruiting - Cholangiocarcinoma Clinical Trials

Biomarker Discovery in Patients With Advanced Biliary Tract Cancer

Start date: April 14, 2021
Phase:
Study type: Observational [Patient Registry]

Biliary tract cancer is a rare gastrointestinal malignant neoplasm and includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancer. Curative surgical resection offers the only chance for cure. However, most patients with BTC are diagnosed at an unresectable stage. Therefore, the survival outcomes of patients with advanced biliary tract cancer remain dismal. The combination of gemcitabine and cisplatin has become the current standard for advanced BTCs since the landmark ABC-02 trial in 2010. However, the median overall survival of Gem/Cis chemotherapy is less than 1 year. Recently, a triplet regimen of gemcitabine, cisplatin, and nab-paclitaxel showed promising results in a single-arm phase II multicenter study. However, biliary tract cancer is a group of heterogenous diseases by site and genetic alteration, and this diversity may lead differences in response to systemic chemotherapy. Transcriptome analysis through RNA-sequencing has rarely been performed in advanced biliary tract cancer, and even if it has performed, only small number of patients were included. Further research on multi-omics data is needed on the necessity and clinical significance in treatment of biliary tract cancer.

NCT ID: NCT04856761 Recruiting - Cholangiocarcinoma Clinical Trials

A Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection

Start date: November 1, 2020
Phase:
Study type: Observational

The purpose of this study is to assess the difference of safety and efficacy about Capecitabine and S-1 for treatment of patients with low-risk of recurrence after BTC surgery.

NCT ID: NCT04561453 Recruiting - Cholangiocarcinoma Clinical Trials

Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer

Start date: July 8, 2020
Phase:
Study type: Observational

This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make decisions on what standard or experimental treatments might benefit the patient's enrolled in the study. The study is observational and does not require any change in the standard approach to treating biliary tract cancer. Results of the personalized tests will be provided to the treating medical oncologist and the medical oncologist can choose to whether or not to change management based on these results. These personalized tests include reading of the cancer DNA, testing whether a panel of drugs can kill a patient's cancer cells in a test tube, and testing for small amounts of cancer DNA in the blood as a way to check for the presence of leftover cancer in the body after it is removed surgically. This study will also give extra pieces of cancer, that would otherwise be discarded, from surgery for laboratory research into how biliary tract cancers respond to drugs and the body's immune system. The investigators hypothesize that the drug screen test will, in some cases, be useful to the medical oncologist and may lead to the use of cancer drugs that would not otherwise have been chosen based on standard guidelines or based on cancer DNA testing. The investigators hypothesize that the test tube drug screening method will correlate with how the cancer responds to the drugs in real life for those patients that end up receiving a drug that was included in the drug screen panel. The investigators hypothesize that monitoring of cancer DNA in the blood stream will help us predict which patients are most likely to have their cancer return after surgery. The investigators also hypothesize that in many cases the appearance of cancer DNA in the blood stream will happen weeks to months prior to the cancer showing up on usual body imaging or other lab tests. Finally, the investigators hypothesize that, for patients undergoing medical treatment for their cancer, trends in the amount of cancer DNA in the blood stream will correlate with the effectiveness of treatment.