Clinical trials

Although standard neoadjuvant chemoradiotherapy (nCRT) for locally advanced rectal cancer (LARC) effectively reduces local recurrence, radiotherapy-related toxicities and surgical complications severely impair patients' quality of life, making a radiotherapy-free strategy urgently needed. However, chemotherapy alone yields a pathological complete response (pCR) rate of only 6.6%-15%, which is far from satisfactory. The pMMR/MSS subtype, accounting for 90% of rectal cancers, is "immune-cold" and shows almost no response to PD-1 monotherapy; nonetheless, chemotherapy can reshape the tumor immune microenvironment, and multiple studies have demonstrated that combining chemotherapy with PD-1 inhibitors (without radiotherapy) can elevate pCR rates to 26.8%-42.9%, yet further improvement remains desirable. A recent mechanistic study published in Cell Metabolism (2026) revealed that a single 16-hour fasting episode before treatment promotes isoleucine accumulation in the tumor microenvironment, which enhances CD8+T-cell cytotoxic function and reduces exhaustion through acetyl-CoA metabolism and epigenetic reprogramming, thereby significantly sensitizing PD-1 inhibitors-and this intervention is non-invasive, low-cost, and easily adoptable by patients. Based on the above evidence, we hypothesize that the neoadjuvant triple-combination regimen of "16-hour fasting + chemotherapy + PD-1 inhibitor" (radiotherapy-free) in pMMR/MSS locally advanced mid-to-low rectal cancer may further increase pCR rates and tumor regression, offering a novel, highly effective, and low-toxicity therapeutic option for LARC patients.

This study aims to observe and evaluate the efficacy and safety of Iparomlimab and Tuvonralimab（QL-1706） combined with chemotherapy and bevacizumab ± radiotherapy as neoadjuvant therapy in patients with locally advanced rectal cancer, and to explore the value and implications of radiotherapy omission in this setting.

The goal of this educational study is to determine whether personalized feedback generated using sensor data and generative artificial intelligence (AI) can improve the learning of standardized Tuina skills among rehabilitation trainees. Tuina is a form of manual therapy that requires learners to control the location, force, rhythm, and consistency of their hand movements. A total of 81 rehabilitation trainees will be randomly assigned to one of three training groups: AI-supported personalized feedback, sensor-based data feedback without AI-generated recommendations, or traditional instructor feedback. All groups will receive the same standardized demonstration, training tasks, practice duration, and number of practice sessions. The main question is whether trainees receiving AI-supported personalized feedback achieve better retention of standardized Tuina skills four weeks after training. The researchers will also compare immediate skill performance, force and rhythm control, transfer of skills to a related task, learning efficiency, self-efficacy, cognitive load, satisfaction, and the safety and acceptability of AI-generated feedback. Skill performance will be assessed using a blinded Objective Structured Clinical Examination (OSCE) and objective sensor-based measurements. The study activities will be conducted using a mechanical simulation model and a pressure-sensing system, rather than on patients.

The goal of this clinical trial is to learn whether individualized transcranial temporal interference stimulation can improve swallowing in adults with swallowing difficulties after an ischemic stroke. It will also evaluate the safety and tolerability of this stimulation. The main questions it aims to answer are: * Does active temporal interference stimulation combined with swallowing rehabilitation improve swallowing safety more than sham stimulation combined with the same rehabilitation? * What side effects or medical problems occur during and after the stimulation? Researchers will compare active stimulation with sham stimulation, which uses the same equipment but does not deliver sustained therapeutic stimulation. Participants will: * Receive active or sham stimulation for 30 minutes per session, 5 days per week for 2 weeks * Receive the same task-specific swallowing rehabilitation after each stimulation session * Undergo swallowing assessments, brain imaging, and neurophysiological testing * Attend follow-up assessments 4 and 12 weeks after treatment

The study aims to evaluation the effects of Liposomal Bupivacaine on diaphragmatic function in patients undergoing upper limb surgery who receive Interscalene Brachial Plexus Block. A total of 120 eligible patients will be enrolled and divided into two groups: Group A will receive 20ml of 0.5% Hydrochloride Bupivacaine , while Group B will receive 10ml of 0.5% Hydrochloride Bupivacaine plus 10ml of Liposomal Bupivacaine. Assessments of diaphragmatic function, pulmonary function, and pain intensity will be performed before the block and at different time points after the block, with follow-up for adverse events. The study is scheduled to run from September 2025 to September 2026, with strict adherence to privacy protection and ethical guidelines.

This study aims to evaluate the safety, tolerability, and efficacy of HRS-2329 in combination with other anti-tumor therapies in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.

This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens.

This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 injection for patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).

This study aims to assess the feasibility of leveraging non-contrast CT and artificial intelligence to detect liver cancer in consecutive real-world patients. To this end, we deploy LEAF in a prospective real-world clinical setting for real-time monitoring, with a particular focus on flagging cases with liver cancer that may be missed by routine clinical workflow.

This multicenter, prospective, randomized, controlled clinical trial is initiated by the First Affiliated Hospital of Zhejiang University School of Medicine, with participation from Peking Union Medical College Hospital, the Fourth Affiliated Hospital of Harbin Medical University, Harbin Medical University Cancer Hospital, and Shanxi Bethune Hospital. The study aims to compare the first-attempt placement success rate between visual bronchial blockers (VBB, test group) and conventional bronchial blockers (CBB, control group) during anesthesia for thoracic surgery, and to evaluate operational efficiency, lung isolation quality, and safety profiles. A total of 652 patients aged ≥18 years with ASA physical status I-III, scheduled for elective pulmonary, esophageal, or mediastinal surgery requiring lung isolation, will be enrolled in a 1:1 ratio (326 per group), with a 10% anticipated dropout rate. Key exclusion criteria include anomalous right upper lobe bronchial origin, severe airway anatomical abnormalities, bronchial sleeve resection, empyema, bronchopleural fistula, previous thoracic surgery altering bronchial anatomy, severe cardiopulmonary dysfunction (metabolic equivalent \<4), severe psychiatric disorders, and concurrent participation in other clinical trials. Following standardized anesthesia induction with rocuronium (2-3 × ED95), patients undergo tracheal intubation using a video laryngoscope. In the CBB group, placement is guided by blind probing and auscultation, with confirmation via fiberoptic bronchoscopy (FOB). In the VBB group, placement is performed under direct vision using the integrated camera, with FOB rescue allowed only if visualization fails (rescue cases are counted as failures). Placement success is defined as the cuff located in the ipsilateral main bronchus with the proximal cuff edge immediately below the carina. Primary endpoint: First-attempt placement success rate. Secondary endpoints: Time to successful first placement, lung collapse grade (Likert 3-point scale), cumulative number and duration of FOB use, intraoperative blocker displacement, hypoxemia (SpO₂ \<90% or \<85% for ≥5 seconds), airway injury, hemodynamic changes, postoperative sore throat, hoarseness, hospital length of stay, ICU admission rate, postoperative pulmonary complications, and 30-day all-cause mortality. Operator and surgeon satisfaction will be rated on a 0-10 scale. Randomization is centralized, stratified by center, using variable block sizes (4, 6, or 8) to ensure allocation concealment. Outcome assessors and patients are blinded to group assignment, while operators are not. An independent Endpoint Adjudication Committee will review imaging data for blinded verification. Statistical analysis will be performed using SPSS 27.0 and R software. Baseline characteristics will be compared using independent samples t-test, Mann-Whitney U test, chi-square test, or Fisher's exact test as appropriate. The primary endpoint (binary variable) will be analyzed using generalized linear mixed models (GLMM) with center as a random effect and logistic regression as a sensitivity analysis. A two-sided P\<0.05 is considered statistically significant. Full Analysis Set (intention-to-treat), Per-Protocol Set, and Safety Set will be defined for efficacy and safety evaluations. The trial timeline includes registration and training (June 2026 - August 2026), patient recruitment and data collection (September 2026 - September 2027), and data analysis, manuscript preparation, and publication (October 2027 - Dec 2028). Adverse events will be monitored, documented, and reported in accordance with CTCAE v5.0; serious adverse events will be reported to the ethics committee within 24 hours. This study is the first randomized controlled trial evaluating a visual bronchial blocker worldwide. The investigators hypothesize that VBB improves first-attempt placement success, shortens positioning time, reduces FOB reliance, enhances lung collapse quality, decreases intraoperative displacement and hypoxemia, and lowers airway injury and postoperative complications. The results will provide high-level evidence for the clinical application of VBB in thoracic anesthesia and promote the visualization and standardization of one-lung ventilation techniques.

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for the diagnosis and treatment of pancreatobiliary diseases. While Monitored Anesthesia Care (MAC) enhances the efficiency of ERCP, deep sedation introduces significant airway risks, particularly hypoxemia resulting from sedative-induced upper airway collapse. With reported hypoxemia rates ranging from 10% to 69%, and the potential for severe complications such as myocardial ischemia and neurological damage, effective airway management is paramount. Supraglottic oxygenation via oral transtracheal catheter provides a viable method for relieving obstruction and enabling positive pressure ventilation, serving as a less invasive alternative to tracheal intubation. Despite its proven utility in other settings, this technique has not yet been evaluated in the context of deeply sedated ERCP.

SOX regimen, consisting of oral S-1 and intravenous oxaliplatin, is the preferred regimen for perioperative chemotherapy for gastric cancer. The goal of this clinical trial is to compare the efficacy and safety between S-1 combined with oxaliplatin by arterial infusion, as neoadjuvant chemotherapy, and conventional SOX regimen, in locally advanced gastric cancer. The main question it aims to answer is: whether arterially infused oxaliplatin plus S-1 has the potential to be a better neoadjuvant option for patients with locally advanced gastric cancer. Participants will be randomised, and receive: * 3 cycles of conventional SOX chemotherapy plus PD-1 antibody or arterial infused oxaliplatin plus S-1 and PD-1 antibody, as neoadjuvant chemotherapy; * Adequate gastric resection along with D2 lymph node dissection; * 3 cycles adjuvant chemotherapy using SOX regimen plus PD-1 antibody. * Administration of S-1 regularly till 1 year after surgery. Researchers will compare Major pathological response rate (MPR) ，pathologic complete response rate（pCR）,the 2-year overall survival (OS) rates, 2-year disease free survival (DFS), R0 resection rates, and adverse events, to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer.

This study is a single-arm phase II clinical study to include 32 patients with advanced pancreatic cancer with KRAS G12D mutation to evaluate the effectiveness of HRS-4642 combined with nitutuzumab and AG for first-line treatment of advanced pancreatic cancer.

The postoperative incidence of catheter-related bladder discomfort (CRBD) ranges from 47% to 95%. It increases postoperative pain and agitation, thus requiring early intervention. Although a variety of drugs are used for the prevention or treatment of CRBD, the adverse reactions of most of these drugs have limited their clinical application. In long-term clinical practice, we found that indomethacin suppository has a good therapeutic effect on the discomfort of pelvic-related organs caused by nociceptive stimulation. However, its preventive effect on CRBD has not been reported yet. We hypothesized that indomethacin suppository has a preventive effect on postoperative CRBD. To verify this hypothesis, patients undergoing laparoscopic radical prostatectomy were enrolled in the study. Patients in the intervention group received 50 mg of indomethacin suppository via the rectal route immediately after surgery, while those in the control group received no treatment. The severity of CRBD, pain scores, consumption of analgesics, other perioperative adverse reactions, and patient satisfaction were observed and recorded at 0, 1, 2, and 6 hours after surgery.

The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract tumors, neuroendocrine tumors, ovarian cancer, and lung cancer. The primary objective of this study is to evaluate the safety and tolerability of UCLH801 cells in patients with CDH17-positive advanced malignant solid tumors. The secondary objectives include assessing the preliminary efficacy of UCLH801 cells, their pharmacokinetics and pharmacodynamics in the body, and their immunogenicity. This study aims to observe how the infusion of UCLH801 cells affects patients 's body, including any discomfort or changes in laboratory test results. Additionally, it will evaluate whether UCLH801 cells have any effect on tumor. Furthermore, the study will investigate how UCLH801 cells are metabolized; the mechanisms through which they exert their effects, and how to develops any immune response or rejection against UCLH801 cells.

Multimodal Thermal Therapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone for systemically untreated unresectable hepatocellular carcinoma (HCC)

Background：KRAS mutations are the most common genetic alterations in colorectal cancer (CRC), associated with aggressive tumor biology and poor prognosis. For metastatic CRC harboring KRAS mutations, first-line standard treatment is chemotherapy plus bevacizumab. However, its anti-angiogenic effects contraindicate perioperative use. KRAS G12C, the first druggable KRAS target, accounts for \~3% of CRC KRAS mutations. KRAS G12C inhibitor monotherapy shows efficacy in post-standard-therapy metastatic CRC, while combination with RAS-MAPK pathway blockade demonstrates superior efficacy. Based on promising frontline data combining KRAS G12C inhibitors with anti-EGFR antibodies in metastatic CRC, we evaluate neoadjuvant fulzerasib plus cetuximab N01 in locally advanced KRAS G12C-mutated CRC, with or without resectable metastases. Methods：Single-arm, multicenter, phase II trial (N=40). Eligibility: age 18-80 years, ECOG 0-1, histologically confirmed colorectal adenocarcinoma (stages T4N0-2M0, T3N2M0, T0-4N0-2M1a \[resectable metastases confirmed by multidisciplinary discussion\]), KRAS G12C mutation, NRAS/BRAF wild-type, pMMR/MSS. Neoadjuvant therapy: fulzerasib (qd, po, d1-28) plus cetuximab N01 (500 mg/m², IV, q2w) for 2 months. Safety assessments (CBC, liver/renal function, QoL) every 2 weeks; CEA monthly. Tumor response assessed by CT chest/abdomen and rectal MRI at 2 months. Radical surgery for responders (cCR patients may choose watchful waiting). Adjuvant therapy per pathological response. Follow-up: CEA every 3 months, CT every 6 months. Primary endpoint: overall response rate (pCR or cCR). Secondary endpoints: ORR, 1-year DFS, 3-year DFS, QoL. RECIST v1.1 for disease assessment; NCI-CTCAE v5.0 for adverse events. Hypothesis：This chemotherapy-free neoadjuvant regimen combining a KRAS G12C inhibitor with cetuximab N01 may enhance perioperative safety and improve prognosis and quality of life in patients with KRAS G12C-mutated CRC.

Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.

Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent problem requiring a solution. High-flow nasal cannula (HFNC) oxygen therapy delivers heated and humidified breathing gas with a precisely controllable oxygen concentration, at flow rates exceeding the patient's peak inspiratory flow, directly via unsealed nasal prongs. It is a simple, comfortable, effective, and non-invasive respiratory support method that has been widely adopted in clinical practice. However, the effectiveness of HFNC in pediatric sedation remains unclear. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxemia during sedated bronchoscopy in pediatric patients.

A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma.

Colorectal cancer (CRC) is one of the most common malignancies in China. Currently, its incidence rate is increasing at a rate of 4% per year, exceeding the global annual average growth rate. Screening and early diagnosis of colorectal cancer and precancerous lesions are key measures to reduce the disease burden of colorectal cancer in China. In previous clinical studies, colorectal cancer screening in high risk population received extensive attention. However, it cannot be ignored that the majority of sporadic colorectal cancers occur in the average risk population. Therefore, there is an urgent need to develop new approach for colorectal cancer screening in the average risk population in China. Fecal Immunochemical Testing (FIT) initial screening followed by diagnostic colonoscopy is widely recommended by colorectal cancer screening guidelines worldwide. The current colorectal cancer screening approach faces challenges including limited sensitivity of initial screening technologies and insufficient population coverage in organized screening programs in China. As initial screening technologies, non-invasive blood tests which detects cfDNA methylation have been reported to have higher accuracy than FIT in detecting colorectal cancer. However, There is a lack of randomized controlled trials (RCTs) comparing the effectiveness of colonoscopy, FIT and FIT plus blood test for colorectal cancer screening. In China Colorectal Cancer Screening Trial 1 (C-Cost1), we propose to perform a multicenter, cluster randomized, parallel group trial directly comparing colonoscopy with FIT and with FIT plus blood test in the average risk population in China. The main research hypotheses are: (1) The screening protocol of FIT group (Group B) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years; (2) The screening protocol of FIT plus blood test group (Group C) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years. Both of the two hypotheses should be met.

A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

The goal of this clinical trial is to evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) combined with triple antiemetics for postoperative nausea and vomiting (PONV) in high-risk patients. The primary question it seeks to answer is: Does TEAS combined with triple antiemetics further reduce the incidence of PONV in high-risk subjects? Researchers will compare active TEAS with sham stimulation to determine whether the addition of TEAS to dexamethasone, palonosetron, and droperidol lowers the PONV rate beyond that achieved by the triple-drug prophylaxis alone.

Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex).Observation contents: Whether there is postoperative delirium and its severity: 3D - CAM assessment scale, DMAS assessment scale; awakening time, extubation time, PACU stay time, hospital stay time; 1 - 7 days after surgery or before discharge, POD assessment and pain - sleep assessment, the first time getting out of bed; postoperative complications; adverse reactions; adverse events, and so on.

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus