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 tests clinical utility.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with other treatments can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and how well the cancer responds to these treatments. Participants will receive sacituzumab tirumotecan in different dose levels either combined with chemotherapy every two weeks in a 4-week cycle, alone every two weeks in a 4-week cycle, or combined with cisplatin and pembrolizumab in a 3-week cycle. Treatment continues until the cancer worsens or participants cannot tolerate it. Cisplatin is given up to approximately six months, and pembrolizumab is administered for up to about two years in the combination group. During the study, participants will have regular assessments to monitor safety, side effects, and how the cancer responds via imaging and clinical evaluation. Researchers will track dose-limiting toxicities, adverse events, treatment discontinuations due to side effects, and objective response rates. Additional measures include duration of response, progression-free survival, and overall survival, with monitoring lasting up to approximately 63 months.

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, endometrial, and squamous non-small cell lung cancers. This Phase IIIa multi-center, open-label study aims to determine the safety, tolerability, and appropriate dosing of AZD8205 alone or combined with other anticancer agents such as rilvegostomig, saruparib, and AZD9574. The study includes dose escalation and expansion parts to assess anti-tumor activity in select solid tumors. Participants are assigned to one of four sub-studies that involve different combinations of AZD8205 with other drugs. Each sub-study has two parts Part A focuses on dose escalation to find safe doses, and Part B evaluates the anti-tumor effects at the recommended doses. Some sub-studies may add triplet combinations based on safety data and may include future protocol amendments. Treatment is given according to the assigned sub-study and dosing schedules. During the study, participants undergo assessments including monitoring for adverse events, serious adverse events, dose-limiting toxicities, and changes in laboratory tests, ECGs, and vital signs. Researchers also measure responses such as objective response rate, duration of response, progression-free survival, disease control rate, overall survival, pharmacokinetics, and immunogenicity over approximately two years. Study participation includes regular visits for treatment and evaluations, with safety follow-up until 30 days after the last dose.

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 collecting data to assess the safety and performance of the da Vinci SP Surgical System, Instruments, and Accessories during hepatopancreaticobiliary HPB and foregut surgeries. These surgeries include cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy for both benign and malignant diseases. The study is designed as a prospective, single-center investigation focusing on these procedures. Participants will be grouped into four stages based on their diagnosed condition, with each participant undergoing one surgical operation using the da Vinci SP Single-Port Robotic Surgical System. Stage One includes patients undergoing cholecystectomy or hiatal hernia repair with fundoplication. Stage Two involves gastrectomy or distal pancreatectomy. Stage Three covers pancreaticoduodenectomy or esophagectomy, and Stage Four includes hepatectomy. The robotic system is designed to enable minimally invasive single-port surgery through a surgeon console, vision cart, and patient cart with camera and instruments. During the study, participants will be monitored through various assessments including operative time, blood loss, intraoperative and postoperative complications, physical status, survival, disease recurrence, and readmission rates. Follow-up evaluations occur up to five years to track outcomes such as adverse events, positive resection margins, lymph node yield, and overall survival. Participants are followed closely after surgery through hospital discharge and at scheduled intervals to provide comprehensive safety and performance data for the system.

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.

Researchers are evaluating the safety and effectiveness of combining Camrelizumab with gemcitabine and oxaliplatin GEMOX chemotherapy for patients with unresectable gallbladder cancer. This single-arm Phase II trial aims to assess how well this treatment approach works to shrink tumors enough to allow surgery and to monitor patients overall disease control and survival. The study is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and expects to enroll 37 patients. Participants receive Camrelizumab at a dose of 200 mg by intravenous infusion on day 1, along with gemcitabine 1000 mgm2 and oxaliplatin 100 mgm2, also given intravenously on day 1. These treatments are given together every 21 days, making one course, for a total of 6 to 8 courses. Tumor markers are tested at each course, and abdominal CT angiography is performed every two courses to check tumor status until progression occurs. During the study, patients undergo regular assessments including blood tests for tumor markers and imaging scans to monitor tumor response. The main outcome measured is the rate of radical tumor removal after treatment. Secondary outcomes include disease control rate, objective response rate, progression-free survival, and overall survival, all assessed at 6 months. Safety is closely monitored by recording any side effects or serious adverse events. Participants are followed throughout the treatment cycles until the tumor progresses or treatment ends.