Esophageal Cancer

Researchers are evaluating the long-term outcomes of stopping endoscopic surveillance in patients with low-risk non-dysplastic Barretts esophagus NDBE. This observational study aims to determine whether discontinuing surveillance leads to an increase in clinically significant esophageal adenocarcinoma EAC, focusing on patients with Barretts esophagus less than 5 cm in length, no history of dysplasia, and no family history of EAC. The study is a nationwide, prospective, single-arm project in the Netherlands with a minimum follow-up duration of 10 years. In this study, endoscopic surveillance is discontinued following new Dutch guideline recommendations for eligible low-risk NDBE patients. Participants are then monitored through existing national registries and medical records without additional procedures or interventions. Two patient groups will be analyzed separately those with prior surveillance history and those newly diagnosed with NDBE at inclusion. Data collection involves pathology reports, national statistics, and cancer registries, with outcomes reviewed annually by a data safety monitoring board. Participants provide informed consent to be included in the registry, but no active involvement or changes to their care are required beyond standard practice. Researchers will track the incidence of clinically apparent EAC, defined by EAC-related death or EAC requiring palliative or non-curative treatments, over at least 10 years. Privacy protections and ethical standards are carefully maintained throughout the study to minimize risks and ensure confidentiality.

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 12a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

Researchers are evaluating if 18F-FAraG PET scans can detect tumors in people with esophageal cancer and predict how they respond to chemoradiation treatment. This phase 1 study aims to assess the imaging tracers ability to identify cancer and forecast complete pathologic response, along with correlations with clinical features, tissue and blood biomarkers, and survival outcomes. Participants will receive a 18F-FAraG PET scan before starting their standard treatment. About 20 minutes before the scan, they will drink water to help clear the tracer from their kidneys. The tracer is given by intravenous injection. Standard imaging will also be done before treatment begins to compare with the research scan. During the study, researchers will monitor safety and adverse events for about one year. Participants will undergo the 18F-FAraG PET scan and standard imaging to evaluate tumor detection and treatment response. Blood and tissue samples may be collected to study biomarkers. The study tracks overall and disease-free survival as part of the long-term follow-up.

Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract GIT cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein FAP expression in tumor samples. This Phase 12a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PETCT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

Researchers are evaluating MDNA11, a long-acting beta-only recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11s effects alone and with pembrolizumab.

Researchers are studying the use of sintilimab as an additional treatment for people with node-positive esophageal squamous cell carcinoma who have undergone radical surgery without prior neoadjuvant therapy. The goal is to assess how well sintilimab works and how safe it is when given after surgery. This is a Phase 2 clinical trial sponsored by Zhejiang Cancer Hospital focusing on this specific type of esophageal cancer. Participants in the study will receive sintilimab at a dose of 200 mg given once on day 1, repeated every 21 days. This adjuvant therapy is intended to be administered after the surgical removal of the cancer. The study does not include a placebo or comparison group, and the treatment will continue according to this schedule. Throughout the study, participants will be monitored regularly, with disease-free survival being tracked for up to 36 months as the primary outcome. Overall survival will also be assessed for up to 60 months. Evaluations will include physical and imaging examinations such as CT or MRI scans of the neck, chest, and abdomen, as well as laboratory tests to check blood counts and organ function. Safety and adherence to treatment will be carefully observed during follow-up visits over the study period.

Researchers are evaluating the safety and effectiveness of a new neoadjuvant treatment combining Cadonilimab, a PD-1CTLA-4 bispecific antibody, with platinum-based chemotherapy Paclitaxel Polymeric Micelles for Injection and Cisplatin for patients with locally advanced esophageal squamous cell carcinoma. This Phase 2 clinical trial aims to measure pathologic complete remission rates after 2 to 4 treatment cycles, alongside other measures like objective remission rate, major pathologic remission rate, surgical removal rate, and 2-year survival outcomes. Participants receive Cadonilimab intravenously at 10 mgkg on day 3 every 3 weeks, combined with Paclitaxel Polymeric Micelles administered intravenously 230 mgm2 for cycle 1 possibly increased to 260 mgm2 for cycles 2-4 depending on blood counts and side effects and Cisplatin intravenously at 25 mgm2 daily for 3 days every 3 weeks. Treatment lasts approximately 12 weeks, covering 2 to 4 cycles before surgery. Throughout the study, participants undergo regular assessments including pathological evaluation after surgery to determine remission, as well as monitoring of overall and progression-free survival over 2 years. Safety and organ function are closely observed, with eligibility requiring adequate heart, liver, kidney, and blood function. Participants are followed from treatment initiation through surgery and beyond to evaluate clinical outcomes and side effects.

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

Researchers are evaluating if ifinatamab deruxtecan I-DXd, an antibody-drug conjugate, can treat advanced esophageal squamous cell carcinoma ESCC. This treatment works by attaching to proteins on cancer cells and delivering therapy to destroy them. The study aims to find out how many participants experience tumor shrinkage or disappearance after receiving I-DXd. Participants will receive I-DXd through intravenous infusion every 3 weeks. Treatment continues until the cancer progresses or other criteria for stopping are met. The study is part of a master screening protocol called KEYMAKER-U06 and focuses on participants with unresectable locally advanced or metastatic ESCC who have had prior systemic therapy. During the study, participants will be monitored for tumor response using objective response rate over about 14 months. Researchers will also measure duration of response, progression-free survival, overall survival, and track adverse events for up to 18 to 26 months. Participants undergo regular assessments including imaging and safety evaluations throughout their participation, which may last several months.

Researchers are studying the use of C-13-60 cells, a type of chimeric antigen receptor T cell therapy CAR-T, for treating patients with advanced malignant solid tumors that test positive for carcinoembryonic antigen CEA. This phase I, single-arm, open-label trial aims to assess the safety, tolerability, and how the drug behaves in the body, while also making early observations on its effectiveness. The study focuses on finding the appropriate dose for future phase II trials in various cancers including colorectal, esophageal, gastric, pancreatic, non-small cell lung, breast, and bile duct cancers. Participants will receive intravenous infusions of CEA-targeted CAR-T cells, with doses increasing stepwise from 2 to 10 million cells per kilogram of body weight. Before the cell infusion, patients undergo conditioning chemotherapy with Fludarabine and Cyclophosphamide to prepare the body. The dose escalation follows strict safety rules groups of patients receive increasing doses, and if severe toxicity occurs, the treatment is adjusted or stopped based on safety committee decisions. The trial includes a 28-day period of monitoring for dose-limiting toxicities after each infusion. Throughout the study, participants will have regular evaluations including tumor assessments, laboratory tests, and monitoring of cell levels in the blood. Researchers will track safety outcomes such as dose-limiting toxicities and maximum tolerated dose within one month. They will also measure disease control rates and various pharmacokinetic indicators over three months. The trial requires participants to agree to contraception use and undergo follow-up to evaluate treatment impact and safety. The overall study duration extends until the end of 2027, with detailed monitoring during and after treatment.