Clinical trials

Residual neuromuscular blockade (NMB) after general anesthesia increases the risk of postoperative respiratory complications (atelectasis, pneumonia, re-intubation) and delays pulmonary function recovery. Sugammadex, a γ-cyclodextrin that directly encapsulates rocuronium, reverses NMB rapidly and completely without cholinergic side effects, whereas neostigmine requires co-administration of an antimuscarinic and may leave residual blockade. In this multicenter, randomized, double-blind, controlled trial, 240 adult patients (ASA I-III) undergoing elective thoracoscopic lung resection (≤ 1 segment) will be randomized 1:1 to receive sugammadex (2 mg/kg) or neostigmine (0.03 mg/kg) + atropine (0.015 mg/kg) at the end of surgery. The primary endpoint is the percent decline in forced expiratory volume in 1 second (FEV₁) at 1 hour post-extubation compared to preoperative baseline; a ≥ 5% improvement with sugammadex is hypothesized. Secondary endpoints include FEV₁ at days 1-3, pain scores, opioid consumption, gastrointestinal recovery, quality of recovery (QoR-15), neuromuscular monitoring (TOF ratio), and incidence of postoperative pulmonary and surgical complications.

This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage II-III non-small cell lung cancer (NSCLC). Eligible participants will be randomized 2:1 to receive either neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy for two cycles, or toripalimab and platinum-based chemotherapy for three cycles. Randomization will be stratified by disease stage and histological subtype. Surgery is planned 4-6 weeks after completion of neoadjuvant treatment, and postoperative adjuvant therapy will be determined by the investigator. The primary endpoint is the 2-year event-free survival rate. Secondary endpoints include pathological complete response rate, major pathological response rate, objective response rate, R0 resection rate, event-free survival, overall survival, and safety. Adverse events will be assessed according to NCI CTCAE version 5.0 or later.

This study is a multicenter, single-arm Phase II clinical trial, aiming to explore the safety and preliminary efficacy of oral paclitaxel solution combined with immune checkpoint inhibitors as a neoadjuvant regimen in elderly patients aged 70-85 years with non-small cell lung cancer (NSCLC). A total of 75 eligible elderly NSCLC patients who need neoadjuvant treatment are planned to be enrolled. The study takes Shanghai Pulmonary Hospital as the main center, Zhejiang Cancer Hospital and Guangdong Provincial People's Hospital as sub-centers, adopts a single-arm study design, and the research subjects are elderly NSCLC patients who need neoadjuvant treatment. The core indicators for efficacy evaluation include pathological complete response rate (pCR), major pathological response rate (MPR, residual tumor cells ≤10%), imaging response rate (according to RECIST 1.1 criteria), 2-year event-free survival rate (EFS), 2-year overall survival rate (OS), surgical resection rate, and R0 resection rate; safety evaluation mainly observes the incidence of adverse events. The statistical methods adopt the relevant specifications for single-arm exploratory studies. Efficacy analysis is carried out in the full analysis set and per-protocol set, and safety analysis is performed using the safety analysis set; for continuous variables, paired t-test or Wilcoxon signed-rank test is used according to the distribution; categorical variables are analyzed descriptively; for the main rate-type outcome indicators, the incidence rate and 95% confidence interval (Clopper-Pearson method) are reported; survival outcome indicators are estimated using the Kaplan-Meier method and relevant parameters are reported.

This study aims to design and conduct a multicenter, prospective, randomized controlled post-market clinical trial to validate the clinical efficacy of high-precision electromagnetic navigation technology.

The aims of this study are to verify the feasibility, effectiveness, and safety of the combination of enrolizumab and radiotherapy for neoadjuvant treatment for locally advanced thymic carcinoma, and to provide recommendations for the establishment of unified evaluation criteria for the neoadjuvant therapy of thymic cancer by evaluating the pathological remission status of thymic cancer specimens after neoadjuvant treatment.

This is a prospective, single-arm, investigator-initiated clinical study (IIT) designed to evaluate the efficacy and safety of nab-paclitaxel combined with local radiotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after first-line treatment. Small cell lung cancer (SCLC) is an aggressive type of lung cancer, and extensive-stage SCLC (ES-SCLC) refers to its advanced stage. For patients whose cancer progresses after first-line treatment, there are very limited effective second-line and later-line treatment options. Commonly used clinical regimens such as topotecan and lurbinectedin only provide modest improvements in tumor response and survival, and often cause severe hematological toxicities (represented by bone marrow suppression). This leaves patients in a persistent dilemma of "insufficient efficacy and limited tolerability", highlighting a clear unmet medical need for better treatment options in this population. Against this background, this study explores a comprehensive treatment strategy using nab-paclitaxel as the chemotherapy backbone, combined with local radiotherapy in eligible patients. Nab-paclitaxel is a nanoparticle albumin-bound form of paclitaxel, with a relatively controllable toxicity profile and manageable administration in clinical practice. Local radiotherapy may create a synergistic effect by improving the tumor immune microenvironment and enhancing local tumor control, with the goal of providing better evidence for a "chemotherapy ± local therapy" combination as a second-line treatment option.

This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.

The goal of this Single-arm, Phase II clinical trial is to learn whether ablation or stereotactic radiotherapy combined with furmonertinib can treat early-stage non-small cell lung cancer in patients who are inoperable or refuse surgery. The main purposes of this study is to answer: Can ablation or stereotactic radiotherapy combined with furmonertinib improve survival in patients with early-stage NSCLC who are inoperable or refuse surgery? Can ablation or stereotactic radiotherapy combined with furmonertinib reduce recurrence in patients with early-stage NSCLC who are inoperable or refuse surgery?

This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.

This study aims to evaluate the efficacy and safety of JSKN016 combined with toripalimab and carboplatin as a neoadjuvant treatment regimen in patients with resectable stage II-III NSCLC.

Shoulder pain is a common problem after certain types of lung surgery called video-assisted thoracoscopic surgery (VATS). This study examines whether a treatment called transcutaneous electrical acupoint stimulation (TEAS) can help reduce this pain. TEAS is a non-invasive technique that uses mild electrical stimulation at specific points on the body.Patients who are having VATS lung surgery will be randomly assigned to either receive TEAS before surgery or standard care. Researchers will measure how much shoulder pain patients experience and compare the two groups.The goal is to see if TEAS can help patients feel less pain and recover better after this type of lung surgery.

This study aims to explore the clinical outcomes of Comprehensive Enhanced Preventive Management (CEPM) combined with an amivantamab-containing treatment regimen in Chinese patients with EGFR-mutated advanced NSCLC.

This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.

This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.

Postoperative pain is common after video-assisted thoracoscopic surgery (VATS), with pleural irritation caused by chest tube placement being a major contributor. Inadequate pain control may impair respiratory function, delay postoperative recovery, and increase the risk of complications. However, effective and targeted analgesic strategies specifically addressing chest tube-related pain remain limited. This is a single-center, prospective, randomized, double-blind, placebo-controlled superiority trial designed to evaluate the efficacy and safety of programmed intermittent intrapleural administration of bupivacaine at different concentrations for postoperative analgesia after VATS. A total of 249 patients undergoing VATS will be randomly assigned in a 1:1:1 ratio to receive intrapleural injections of 0.25% bupivacaine, 0.125% bupivacaine, or normal saline. The primary outcome is pain intensity during coughing within 48 hours after surgery. Secondary outcomes include pain intensity at rest, plasma bupivacaine concentrations, quality of postoperative recovery, cumulative opioid consumption, and postoperative inflammatory marker levels. This study aims to provide evidence to inform analgesic strategies for chest tube-related pain following VATS and to clarify the optimal use and safety profile of intrapleural bupivacaine.

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course regimens (BDLLfxC or BDCZ) in patients with multidrug-resistant tuberculosis (MDR-TB). The primary objectives are to assess the safety and tolerability of AHA combined with short-course regimens, and to determine the recommended phase II dose (RP2D) of AHA. The secondary objectives include evaluating the 8-week sputum culture conversion rate, pharmacokinetic parameters, and exploring DNA damage repair biomarkers as potential indicators of treatment response.

This study is a multi-center, observational study aiming to develop an early screening multi-model for detecting lung cancer signals through the integration of imaging (non-contrast CT) and blood testing (cfDNA methylation).

This trial is a prospective, observational study of non-small cell lung cancer that aims to evaluate the feasibility, preliminary efficacy and safety of patient-derived tumor-like cell cluster model in guiding the precision treatment strategy.

This study is a prospective, single-arm, exploratory clinical research aimed at evaluating the efficacy and safety of lucetamab in combination with leucovorin in the conversion therapy of locally advanced potentially resectable EGFR mutation-positive non-small cell lung cancer, providing more robust clinical evidence for the improvement of treatment modalities for EGFR-mutated locally advanced NSCLC. At the same time, it seeks to identify biomarkers that can predict the therapeutic effect of the combination of lucetamab and leucovorin, offering more precise guidance for the selection of clinical treatment plans and enabling patients to receive the optimal treatment regimen.

The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2/MYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2/MYC and the efficacy of teniposide.

This study aims to synthesise PET data that preserves biological relevance and adds clinical value to the diagnosis and prognosis of lung cancer by establishing anatomical-to-metabolic mapping based on paired diagnostic CT and FDG-PET scans, thereby prospectively validating the clinical utility of the model.

Bronchiectasis is a heterogeneous airway disease with diverse causes, making precise diagnosis, prognosis, and treatment response prediction challenging. Identifying patient subgroups (phenotypes) and molecular profiles (endotypes) can enhance individualized assessment and management. While prior studies, primarily in European populations, have identified key phenotypes and endotypes, their relevance to Chinese patients remains unclear due to geographic and clinical differences. Specific causes of bronchiectasis, such as allergic bronchopulmonary aspergillosis (ABPA) and primary ciliary dyskinesia (PCD), may also exhibit distinct pathophysiology requiring further exploration. The C-BRIDGE Study seeks to characterize phenotypes and endotypes in Chinese bronchiectasis patients during stable disease and exacerbations, evaluate differences in clinical outcomes across these subgroups, and develop personalized medicine strategies based on these findings, applicable in China and globally. Primary Objective: To identify molecular endotypes of bronchiectasis that accurately predict prognosis and guide treatment responses. Secondary Objectives: To characterize molecular endotypes of stable bronchiectasis in Chinese patients. To define molecular endotypes of bronchiectasis exacerbations in Chinese patients. To investigate molecular endotypes specific to allergic bronchopulmonary aspergillosis (ABPA). To explore genotypes and inflammatory endotypes of cystic fibrosis (CF) and primary ciliary dyskinesia (PCD) in Chinese patients. To validate candidate biomarkers for stable and exacerbation endotypes to support stratified medicine. To conduct in vivo or in vitro proof-of-concept studies using phenotypic data to identify patient subgroups likely to benefit from specific pharmacological interventions. Study Design: This observational cohort study will link identified patient subgroups with meaningful clinical outcomes to inform prognosis and optimize treatment strategies.

The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. The LAURA study established a new paradigm of targeted consolidation therapy after CRT for patients with EGFR mutations. Although retrospective data support the efficacy of ALK-TKIs, no randomized controlled trial (RCT) has clearly demonstrated the value of ALK-TKI maintenance therapy after CRT. This study adopts a multicenter, randomized, double-blind, placebo-controlled design aimed at evaluating the efficacy and safety of ensartinib in patients with ALK-positive unresectable stage III NSCLC.

This study is a prospective, multicenter randomized controlled trial (RCT) designed to compare the efficacy of segmentectomy and lobectomy for invasive lung adenocarcinoma with a diameter of 2-3 cm and intraoperative frozen section-confirmed IASLC pathological new grade 1-2. The non-inferiority of segmentectomy is primarily evaluated by 5-year relapse-free survival (RFS) and overall survival (OS) after surgery, while secondary endpoints include pulmonary function preservation, perioperative complications, etc. With a planned enrollment of 587 patients over a 3-year recruitment period and a 5-year follow-up, this study aims to identify an optimized surgical approach.

Study Summary This clinical trial aims to evaluate the efficacy and safety of the traditional Chinese herbal formula Huanjingjian decoction in women with premature ovarian insufficiency (POI). The study is designed to address the following key questions: 1. Does Huanjingjian decoction improve clinical symptoms in patients with POI? 2. What adverse medical events, if any, occur during the treatment with Huanjingjian decoction? To answer these questions, researchers will compare Huanjingjian decoction plus hormone replacement therapy (HRT) with placebo plus HRT, in order to determine whether Huanjingjian decoction provides additional therapeutic benefits in the management of POI. Participants will: Receiving either Huanjingjian decoction plus HRT, or placebo plus HRT. Attending monthly clinic visits over a 6-month period for clinical assessments and laboratory testing. Keeping a detailed diary to record symptoms, treatment adherence, and menstrual flow, as measured by the number of sanitary pads used.