Clinical Research Directory

Opioid-free Anesthesia and Postoperative Delirium

Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery. This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 654 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay. The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients.

KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting

This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.

A Study of SKB571 in Participants With Gastrointestinal Tumors

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.

A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M24D1 for Injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.

A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)

This study will be conducted to assess the safety and tolerability of E7386 in participants with solid tumor including CRC.

A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

This study is an open-label, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of Lutetium \[177Lu\] BL-ARC001 in patients with locally advanced or metastatic solid tumors.

A Study of SYS6010 in Combination With SYH2051 in Patients With Advanced Colorectal Cancer and Other Gastrointestinal Tumors

This study is an open-label, non-randomized trial design, including a dose escalation phase and a dose expansion phase, to evaluate the safety, tolerability and preliminary anti-tumor activity of SYS6010 in combination with SYH2051 in patients with advanced gastrointestinal tumors.

Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment

Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors

Combined Screening for Gastrointestinal Tumors

All participants are required to complete a questionnaire, a Helicobacter pylori (H. pylori) test, and a fecal immunochemical test (FIT). The questionnaire covers nine aspects: basic information of the participants, symptoms and previous examinations, medical history and surgical history, medication history, smoking history, alcohol consumption history, dietary habits, physical exercise, and family history. After quality control, the data is entered by staff into the Zhejiang Province Cancer Screening Information Platform. Risk assessments are performed based on the data collected and high-risk individuals are recommended for clinical screening. Additionally, tongue image, stool, urine, blood, tongue coating, saliva, gastric juice, and fresh tissue (gastric mucosa tissue and/or intestinal polyp tissue) samples are collected from all participants undergoing clinical screening. Participants are required to complete at least one passive follow-up annually. Active follow-ups are conducted for those with positive screening results to ensure timely completion of endoscopic examinations. For those who have not undergone endoscopic examinations despite positive screening results, health education is provided, and they are mobilized at least four times within one month to complete endoscopic examinations. For participants diagnosed and treated for precancerous lesions and tumors, diagnostic and treatment data must be collected, and they are encouraged to follow up as per medical advice. Both active and passive follow-up results must be recorded in the screening follow-up information record form and reported to the Zhejiang Province Cancer Screening Information Platform. This is a government collaboration project. All subjects will also be followed by record linkage to Cancer Register and Population Register.

The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors

In this study, perioperative propranolol β-blockade was administered to patients with surgically resectable primary gastrointestinal tumors to explore the safety, efficacy, and alleviation of perioperative psychological stress. At the same time, a multi-omics study was conducted using clinical samples to explore the activation of anti-tumor immune response and its mechanism.

A Study of GNC-077 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

This study is an open-label, multicenter, dose-escalation and cohort expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.

PD-L1 Targeting Molecular Imaging of Solid Tumors

The objective of the study is to constrcut a noninvasive approach WL12 PET/CT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1/L1 treatment.

BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors

This study is an exploratory single-arm, open, modified "3+3" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent/refractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection. Four dose levels were designed for this study: 1.0×10\^8cells, 3.0×10\^8cells, 1.0×10\^9cells, and 3.0×10\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent/refractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.

Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors

The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.