Clinical Research Directory

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

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.

Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine/tipiracil (FTD/TPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD/TPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).

EULAT Eradicate GBC

Gallstones are relatively frequent in women and constitute one of the main risk factors for gallbladder cancer (GBC). Currently, GBC diagnosis is mainly based on imaging (ultrasound or abdominal CT) associated with invasive examinations (biopsy and surgery), with no marker available to date to accurately predict risk and diagnose the disease early. The only curative treatment for GBC remains surgery with complete resection of tumors in early stages. Given the aggressiveness of GBC and the very limited therapeutic options, as well as the possibility of preventing GBC by cholecystectomy during the 10 to 20 years required for the development of gallbladder tumors, it is imperative to develop effective and efficient prevention strategies based on a prioritization of interventions according to environmental and genetic-molecular risk factors. The investigators aim to identify epidemiological factors linked to the development of GBC, and to identify, validate and functionally characterize genetic-molecular markers in blood, saliva, urine, bile and stool that allow risk prediction, early diagnosis and precision treatment of incidental tumors.

Integrated Cancer Repository for Cancer Research

The iCaRe2 is a multi-institutional resource created and maintained by the Fred \& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer

This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody M5A PET, may help find and diagnose CEA positive cancer that may not be detected by standard diagnostic methods.

STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC. There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block. We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big. The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.

A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in patients with previously untreated cholangiocarcinoma or those that have progressed after first-line treatment for cholangiocarcinoma. The main questions it aims to answer are: * is the new drug plus standard treatment safe and tolerable * is the new drug plus standard treatment more effective than standard treatment

Predicting Incidental Gallbladder Cancer

The goal of this observational study is to identify risks factors for incidental (unexpected) gallbladder cancer in adult patients undergoing routine gallbladder surgery (cholecystectomy) for conditions such as gallstones or infection. The main question it aims to answer is: Can the investigators use risk factors for incidental gallbladder cancer to develop a diagnostic score which could be used to stratify the risk of gallbladder cancer in patients undergoing routine cholecystectomy? Participants undergoing gallbladder surgery will be identified by surgical trainees and data will be collected about the patients, their tests and the findings at their operation. The surgical trainees will also collect the result of any laboratory tests on their gallbladder. The study will occur in two stages - the first stage, called a feasibility phase, will test the study design and make sure that it is possible to collect the necessary information. If this stage is a success then information will be collected from as many as 30,000 patients. There will also be an interview-based study running alongside the feasibility phase, which will explore perceptions of the risk of incidental gallbladder cancer in routine gallbladder surgery, and whether - with a good diagnostic score - it could be acceptable to only send high-risk gallbladder's for histopathology.

Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT)

The goal of this clinical trial is to evaluate the efficacy and safety of combining Gemcitabine, nab-Paclitaxel, Lenvatinib, and Tislelizumab in adults aged 18-75 years with advanced unresectable biliary tract malignancies (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma). The main questions it aims to answer are: What is the objective response rate (ORR) of this quadruplet regimen as first-line therapy? What are the secondary outcomes, including disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile? This is a single-arm, open-label, phase II study with no comparison group. Participants will: Receive Gemcitabine (1000 mg/m² IV on Days 1 and 8) and nab-Paclitaxel (125 mg/m² IV on Days 1 and 8) every 3 weeks. Take Lenvatinib (4-8 mg orally daily on Days 1-21). Receive Tislelizumab (200 mg IV on Day 1) every 3 weeks. Undergo 6-8 treatment cycles (adjusted for tolerability) with regular imaging, laboratory tests, and safety assessments. Be followed for 3 years to monitor survival and long-term outcomes. The study plans to enroll 29 participants and will be conducted at a single center over 36 months.

Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer

Considering that the poor prognosis of resected biliary tract cancer and negative impact on the survival outcomes of R1/R2 resection, neoadjuvant chemotherapy may improve R0 resection rates and the survival outcomes of patients with resectable biliary tract cancer. The addition of durvalumab to gemcitabine/cisplatin as neoadjuvant chemotherapy may improve the R0 resection rates compared to gemcitabine/cisplatin in patients with localized biliary tract cancer. In this phase 2 trial, a total of 45 patients with localized biliary tract cancer will be 2:1 randomized to durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin.

Proteomic Analysis of Patients Undergoing Bariatric Surgery

The expression of proteins in the blood of obese individuals is different from the expression of proteins in healthy individuals, and is also different in individuals after bariatric surgery. Therefore, this research aims to better understand protein expression in patients indicated for surgical treatment of obesity, evaluating the pre-operative and post-operative status. The objective of this research is to better understand protein expression in patients indicated for surgical treatment of obesity, evaluating the pre-operative and post-surgery status.

Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer

This is a randomized controlled study to evaluate the efficacy and safety of toripalimab plus capecitabine as postoperative adjuvant therapy for patients with resectable advanced extrahepatic biliary tract cancer.

Addition of Everolimus to Standard of Care in Carcinoma Gallbladder

Gallbladder cancer (GBC) is the most common malignant tumour of the biliary tract. It is also the most aggressive cancer of the biliary tract with the shortest median survival from the time of diagnosis. Currently, radical resection is the most effective strategy to potentially cure GBC. Chemotherapy and radiotherapy have been employed as adjuvant and palliative setting, however, the overall survival is still dismal. This study aim to evaluate the addition of Everolimus in addition to standard of care in gallbladder cancer.

NGS in Gallbladder Cancer and Response to Treatment

Evidence suggests distinct models of molecular and pathologic progression, and a growing body of genetics data points to a heterogeneous collection of underlying mutations in key oncogenes and tumor suppressor genes. Although tumor genetics have been used to tailor individual treatment regimens and guide clinical decision making in other cancers, these principles have not been applied in gallbladder malignancy. Recent clinical trials with targeted therapies seem promising, although the relationships between subsets of patients with positive responses to therapy and tumor genetics remain unexplored.

The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer

The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.

Quebec Pancreas Cancer Study

The Quebec Pancreas Cancer Study is a prospective clinic-based study consisting of clinical, family history and epidemiologic data, with accompanying biospecimens, from patients diagnosed with either pancreas cancer, a related cancer or a related pre-cancerous condition, and their families.

Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer

The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy.

UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up

Copy number variation(CNV) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CNV is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CNV of the DNA extracted from bile samples in gallbladder seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with gallbladder cancer. CNV 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 CNV thus helping diagnose gallbladder cancer and assessing follow-up.

The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer

In this study, the investigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.

The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases

The aim of the study is to establishing a standardized biobank and a clinical information database for patients with benign and malignant tumors of the biliary system. With follow-up plans and advanced multiomics technology, a multiomics database for patients with benign and malignant tumors of the biliary tract will be further established. Based on the above work, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy based on multiomics characteristics and molecular typing of biliary tract tumors.

Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer

Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Objective response rate via investigator, Safety; Secondary endpoints: disease control rate, disease-free survival, overall survival, and proportion of acceptable radical resection of primary lesions; Main characteristics of enrolled patients: Patients with initially unresectable gallbladder cancer; Interventions: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab; Sample size: Using Simon's two-stage design, 15 patients in the first stage, and if more than 4pts response, enlarge the sample size to 45 patients in total; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 9 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 5.0; Follow up: every 90 days (±7 days) until the subject died, lost follow-up or the end of the study.

Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer

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.