Gallbladder Cancer

Biliary tract carcinoma (BTC) includes cancers of the gallbladder, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma. It is a highly aggressive cancer with poor outcomes, ranking sixth in gastrointestinal cancer incidence and tenth in cancer-related deaths worldwide. Because early symptoms are often absent and the disease tends to recur and spread, only about 16.5% of patients can have curative surgery, and the overall 5-year survival rate is under 5%. Early and accurate detection is crucial to improve patient outcomes. This research aims to assess the use of cell-free DNA (cfDNA) methylation in blood as a liquid biopsy for diagnosing and managing BTC. The study involves several groups, including healthy individuals, patients with confirmed benign biliary lesions, other gastrointestinal cancers, and those with confirmed or suspected BTC. Researchers will analyze methylation patterns in circulating tumor DNA (ctDNA), a small fraction of cfDNA that carries tumor genetic and epigenetic information. This approach is studied for its potential to detect BTC early, assist in differential diagnosis, monitor prognosis, and guide therapy. Different cohorts serve as internal training, validation sets, and independent validation groups. Participants will provide blood samples and undergo clinical evaluations to measure the accuracy of the ctDNA methylation test in diagnosing BTC. The study will assess diagnostic performance by cancer subtype and stage, and ability to distinguish BTC from other conditions. Vital signs, organ function, and other health markers will be monitored to ensure participant safety. The study welcomes adults aged 18 to 80 years, with follow-up and assessments continuing until May 2026 to evaluate the test's clinical utility.

Researchers are studying sacituzumab tirumotecan, alone or combined with other treatments, to see if it can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to learn about the safety and tolerance of sacituzumab tirumotecan and how many participants experience a reduction or disappearance of their cancer. Participants receive sacituzumab tirumotecan at one of two dose levels, either alone or with chemotherapy given every two weeks, or with cisplatin and pembrolizumab on a three-week cycle. Treatments continue until the cancer worsens or side effects prevent further treatment. Rescue medications and supportive care are also provided to help manage side effects. During the study, researchers monitor participants for side effects, treatment tolerance, and cancer response using standard criteria. Outcomes include the number of participants experiencing dose-limiting toxicities, adverse events, discontinuation due to side effects, and objective response rates. The study may last up to approximately 63 months, with ongoing safety and efficacy evaluations throughout.

Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.

Researchers are studying whether highly focused and intense radiation can be safely delivered to tumors in the abdominal area or chest using a high-strength MRI-guided radiotherapy machine called an MR-Linac. This approach aims to improve treatment by limiting radiation exposure to surrounding organs while providing better imaging and real-time treatment adaptation compared to standard x-ray guided methods. The study is observational and intends to compare patient experiences and outcomes with those receiving standard treatments. The study involves using MRI-guided stereotactic ablative radiotherapy (SABR) for patients with small, localized tumors in the thorax or abdomen. This method offers superior imaging during treatment, real-time adjustments, and the possibility to collect additional research images without extra radiation. Participants will receive treatment following established guidelines for abdominal or central lung SABR. Researchers will assess if MRI guidance improves treatment delivery and patient outcomes compared to standard care. Participants will be monitored to see if over 85% complete their radiotherapy as planned within 30 months. The study will collect data on patient experiences, tumor and tissue changes during treatment, and follow-up information for at least one year. Safety is carefully monitored, especially regarding MRI compatibility. The total participation time varies, with follow-up assessments to evaluate treatment success and patient well-being after therapy.

Researchers are evaluating LNCB74, an antibody drug conjugate, in participants with advanced solid tumors including ovarian, breast, endometrial, biliary tract, and non-small cell lung cancers. This phase 1, open-label study aims to determine the safety, tolerability, and the recommended dose for future studies by escalating doses and expanding treatment in selected tumor types. The study is sponsored by NextCure, Inc. and focuses on participants with measurable disease and adequate organ function. Participants will receive LNCB74 intravenously every 21 days in two parts: Part 1 involves dose escalation to find the maximum tolerated dose or recommended phase 2 dose, with additional safety and biomarker assessments. Part 2 involves dose expansion and optimization to further evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics in a more uniform group of participants. Treatment continues unless unacceptable side effects or clear disease progression occur. During the study, participants will undergo regular safety and response evaluations including tumor assessments, biomarker analysis, and pharmacokinetic measurements. Key outcomes include safety, tolerability, response rates, and progression-free survival over up to 24 months. Blood samples will be taken to study drug levels and immune response. Participants are monitored closely for adverse effects and effectiveness, with a minimum life expectancy of 12 weeks required to join.

Researchers are evaluating AZD8205, a new antibody drug conjugate, as a possible treatment for advanced or metastatic solid tumors including breast cancer, biliary tract cancer, ovarian cancer, endometrial cancer, and squamous non-small cell lung cancer. This Phase I/IIa multi-center, open-label study aims to determine the safety, tolerability, and effectiveness of AZD8205 alone or combined with other anticancer agents such as rilvegostomig, saruparib, and AZD9574 in participants with advanced solid tumors. The study consists of four sub-studies, each with dose escalation and expansion phases. Sub-Study 1 tests AZD8205 alone; Sub-Study 2 evaluates AZD8205 combined with rilvegostomig; Sub-Study 3 assesses AZD8205 combined with saruparib, with possible addition of rilvegostomig; and Sub-Study 4 examines AZD8205 combined with AZD9574, with possible addition of rilvegostomig. Participants receive the study drugs according to assigned groups, and doses are adjusted to find the recommended dose and assess anti-tumor activity. Participants undergo regular assessments including monitoring for adverse events, laboratory tests, ECGs, and vital signs from consent through 30 days after the last dose, lasting about one year. Tumor response, survival, pharmacokinetics, and immunogenicity are evaluated over approximately two years. Safety and tolerability are closely tracked throughout. The study involves randomized allocation without blinding, with detailed follow-up to measure the impact of the treatments on disease progression and patient health.

Researchers are evaluating the safety of Tasfygo in patients with unresectable biliary tract cancer who have a specific FGFR2 fusion gene and whose cancer has progressed after chemotherapy. This observational study aims to monitor how participants respond to Tasfygo in a real-world setting without altering their standard care. Participants will receive Tasfygo tablets at a dose of 35 mg as part of their normal treatment routine. Since this is a non-interventional study, researchers will not assign treatments but will observe and collect data on participants who are already prescribed Tasfygo. The study will follow participants for up to one year to assess safety and response. During the study, researchers will track the number of participants experiencing adverse drug reactions and assess the best overall response based on physicians' evaluations. Data will be collected through regular clinical assessments over the course of the year. Participants will continue their usual care alongside study observations, and the total participation time spans up to one year.

Researchers are evaluating the safety and performance of the da Vinci SP Surgical System, Instruments, and Accessories in hepatopancreaticobiliary (HPB) and foregut surgeries. These operations include cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy for both benign and malignant diseases. The study aims to collect data on the system's use in these complex surgical procedures at a single center. The study is divided into four stages based on the participant's diagnosis and the type of operation. Each participant will undergo one operation using the da Vinci SP-assisted Single Port Robot. Stage One involves cholecystectomy and hiatal hernia repair with fundoplication. Stage Two includes gastrectomy and distal pancreatectomy. Stage Three covers pancreaticoduodenectomy and esophagectomy. Stage Four involves hepatectomy. The da Vinci SP system uses a minimally invasive single-port approach with a surgeon console, vision cart, patient cart, camera, instruments, and accessories. During the study, participants will be monitored for completion of surgery using the planned robotic system, intraoperative and postoperative adverse events, positive resection margins, and lymph node yield over periods up to 24 months. Additional assessments include physical status, comorbidity scores, operative time, blood loss, complications, mortality, discharge date, survival, disease recurrence, and readmission rates. Follow-up extends annually through five years to evaluate long-term outcomes and safety. Participants will be observed closely to collect comprehensive surgical and recovery data.

Researchers are evaluating a combined treatment approach for advanced gastrointestinal tumors, focusing on the interaction between radiation therapy and immunotherapy. The study aims to design a first-line treatment protocol using macrofractionated radiotherapy to activate the immune system, along with the potential synergistic effects of the Probio-M9 microbial agent and PD-1 inhibitors. This randomized, multicenter phase II basket study includes patients with various advanced digestive system malignancies such as gastric adenocarcinoma, hepatocellular carcinoma, biliary tract carcinoma, and colorectal adenocarcinoma. Participants are assigned to receive either Probio-M9 with hypofractionated radiotherapy or a placebo with radiotherapy, followed by immunotherapy-based systemic treatments. The radiotherapy involves targeting one primary or metastatic tumor focus with doses of 5-10 Gy per fraction over 3-5 fractions. Immunotherapy includes administration of anti-PD-1 monoclonal antibodies and chemotherapy agents such as oxaliplatin, capecitabine, bevacizumab, gemcitabine, and cisplatin, depending on the cancer type. The study groups correspond to specific tumor types and compare the effects of adding Probio-M9 to standard treatment. During the study, participants will be monitored through assessments of tumor response using the objective response rate (ORR) at two months after radiotherapy. Additional evaluations include adverse effects, quality of life, progression-free survival, and overall survival with follow-ups lasting up to 10 years. Safety and treatment adherence will be closely observed. The total participation timeline includes regular clinical visits and assessments to measure treatment outcomes and patient well-being.

Researchers are studying whether fecal microbiota transplantation (FMT) can help treat gastrointestinal symptoms caused by chemotherapy or targeted therapy in patients with gastrointestinal cancers. This Phase 1 trial aims to evaluate the effect of FMT on the gastrointestinal tract in these patients, focusing on those with advanced gastrointestinal tumors. The goal is to understand how FMT might reduce side effects linked to cancer treatment. Participants are randomly assigned to one of two groups. The control group continues their usual chemotherapy or targeted therapy cycles every three weeks for five cycles, with treatment effectiveness assessed after every two cycles. The experimental group receives FMT starting from the fourth treatment cycle, with capsules containing donor gut bacteria given orally within three days before chemotherapy during the fourth, sixth, and eighth cycles. Each FMT dose includes about 40 grams of bacteria encapsulated into 120 capsules, taken over a short period during each treatment cycle. Throughout the study, patients undergo regular assessments to track gastrointestinal symptoms and gut microbiota changes. Researchers monitor the incidence and improvement of gastrointestinal side effects at 4 and 8 weeks after FMT. They also analyze gut microbiota diversity and its correlation with symptom improvement. Participants are followed during treatment cycles and for a post-treatment period to evaluate these outcomes, with safety and organ function closely observed.