Clinical Research Directory

Chinese Population Health and Multimorbidity Study

The Chinese Population Health and Multimorbidity Study (CPHMS; initially named China Pulmonary Health Study, CPHS) was a large-scale epidemiological survey designed to investigate the pulmonary health of Chinese adults aged 20 years or older leveraging a multistage stratified sampling scheme between 2011 and 2014 in mainland China. Briefly, a total number of 57,779 local residents were recruited from 10 representative provinces and municipalities and were invited to participate in the study. A final number of 50,991 adults who met the major inclusion criteria could be considered in further analyses. In order to investigate the changes of pulmonary health and disease status (e.g. occurrence and development of chronic respiratory diseases and other important relevant multimorbidities, lung function indices, etc.) and corresponding impact factors in the CPHMS study population, we plan to initiate the first round of follow-up investigation between 2025 and 2027 (planned) , i.e. more than 10 years after the baseline survey.

A Study of LM-350 in Subjects With Advanced Solid Tumours

For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-350 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explore the relationship between the biomarkers and the anti-tumor activity of LM-350. For Phase II Dose Expansion Stage, to assess the preliminary anti-tumor activity of LM-350 in patients with advanced solid tumors.

PET/CT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors

This prospective, open-label Phase I/II trial evaluates a PET/CT-guided planning strategy for radioactive seed implantation therapy in malignant solid tumors. The approach integrates metabolic information from PET/CT into brachytherapy planning to improve the accuracy of biological target volume delineation, enhance dose coverage, and support biologically informed dose delivery. Eligible participants are assigned to one of three arms: conventional CT-guided implantation, PET/CT-guided standard-dose implantation, or PET/CT-guided biologically optimized implantation. All participants undergo image-guided treatment followed by post-implant dosimetric verification and standardized clinical follow-up. Primary endpoints include technical success rate, dosimetric superiority, and 6-month local control. Secondary endpoints include dosimetric indices (D90, V100, conformity index, homogeneity index), pain relief, quality of life (EORTC QLQ-C30), treatment-related adverse events (CTCAE v5.0), progression-free survival (PFS), failure-free survival (FFS), and overall survival (OS). Exploratory analyses will evaluate associations between baseline PET metabolic parameters (SUVmax, metabolic tumor volume) and clinical outcomes, assess the feasibility of SUV-guided dose painting, and compare the performance of tumor-specific tracers (such as PSMA and FAPI) with FDG for target delineation and treatment response prediction. The central hypothesis is that PET/CT-guided planning-particularly when incorporating biological dose optimization-will achieve superior dosimetric performance and improved local control and survival outcomes compared with conventional CT-guided implantation.

125I Seed Brachytherapy Combined With Immunotherapy for Primary, Recurrent, or Metastatic Malignant Tumors

This prospective randomized trial evaluates the efficacy and safety of combining 125I seed interstitial brachytherapy with immune checkpoint inhibitor therapy in patients with primary, recurrent, or metastatic malignant tumors. Immunotherapy has become an important systemic treatment option, yet many patients experience limited benefit due to low tumor immunogenicity, insufficient T-cell infiltration, and an immunosuppressive tumor microenvironment. 125I seed brachytherapy provides continuous low-dose-rate radiation to the tumor, promoting antigen release, enhancing dendritic cell activation, and potentially converting immunologically "cold" tumors into more responsive "hot" lesions. Integrating localized radiation with systemic immunotherapy may improve tumor response, prolong progression-free survival, and reduce recurrence. Patients will be randomized 1:1 to receive 125I seed implantation plus immunotherapy or immunotherapy alone. The primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include failure-free survival (FFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), local control, recurrence rate, adverse events, and quality of life. Exploratory analyses will assess radiomics features, subgroup responses, and different patterns of recurrence. This study aims to determine whether adding 125I seed brachytherapy enhances the clinical benefits of immunotherapy across diverse malignant tumors.

Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors

The project's objective is to recruit patients with clinically confirmed or suspected small cell lung cancer, breast cancer, nasopharyngeal carcinoma and other tumours for 68Ga-FL-031 PET imaging and 18F-FDG PET imaging. The histopathology of biopsy or surgical specimens was taken as the final diagnostic criteria, and the presence or absence of tumour lesions was confirmed by the aforementioned imaging. The location and nature of the lesion, and the presence or absence of metastasis, were then judged. The objective was to analyse and clarify the diagnostic efficacy of 68Ga-FL-031 PET imaging for the aforementioned malignant tumours. The objective of this study is to analyse the correlation between the 68Ga-FL-031 PET imaging tumour tissue uptake value and the tumour tissue immunohistochemical staining SSTR2 target expression.

Exploring Gut Microbiome Differences in Female Cancer Patients With Varied Ovarian Function and Fertility Outcomes Following Immune Checkpoint Inhibitor Therapy

The goal of this observational study is to evaluate the impact of Immune Checkpoint Inhibitor (ICI) treatment on ovarian function and fertility, and to explore the role of gut microbiota in female cancer patients of reproductive age (18-38 years) receiving ICI therapy. The main questions it aims to answer are: Does ICI treatment alter serum hormone levels (FSH, LH, E2, P, AMH) associated with ovarian function and fertility? Are there differences in gut microbiota composition and metabolites between patients with different ovarian function and fertility outcomes after ICI treatment? What are the potential mechanisms by which gut microbiota influences ovarian function and fertility in patients receiving ICIs? Researchers will compare patients with preserved ovarian function versus those with impaired ovarian function after ICI treatment to identify differences in gut microbiota and metabolic profiles. Participants will: Provide blood samples (10 ml per collection) at enrollment and after each of the 6 treatment cycles for hormone level testing and potential future analyses. Provide stool samples at the same time points for gut microbiota metagenomic sequencing and metabolite analysis. Undergo regular clinical assessments and follow-ups as part of their standard ICI treatment.

The Predictive Value of Serum Histone Succinylation in Malignant Solid Tumors

In recent years, advances in protein post-translational modification (PTM) research have revealed histone succinylation as a novel epigenetic modification mechanism critically involved in tumor initiation, progression, and prognosis. Succinylation alters protein physicochemical properties and functions, thereby modulating cellular metabolism, proliferation, and apoptosis. Aberrant histone succinylation in tumor cells demonstrates significant correlations with tumor type, staging, and clinical outcomes, offering new avenues for early cancer diagnosis. This project utilizes blood serum samples to quantify histone succinylation levels through modification-specific antibody-based detection. Integrated with clinical data, this approach enables early, rapid, and accurate pan-cancer diagnosis, achieving tumor screening via a single-tube blood test. It represents a paradigm shift in precision oncology from "gene-driven" to "epigenetic-metabolic-driven" early detection.

Application of KRAS Vaccine in the Treatment of KRAS-mutated Malignancies

The goal of this study is to evaluate the safety and efficacy of mRNA vaccine for the KRAS mutation malignant tumors.

Application of mRNA Immunotherapy Technology in Epstein-Barr Virus-related Refractory Malignant Tumors

The purpose of this study is to evaluate the efficacy and safety of mRNA vaccine for the EBV-positive Advanced Malignant Tumors.

Study of LM-299 in Subjects Advanced Malignant Tumors

For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours.. For Phase II Dose Expansion Stage, to assess the antitumor activity of LM-299 in patients with various advanced solid tumors.

A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors

This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.

Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study

The goal of this observational study aims to preliminarily evaluate the diagnostic efficacy of 99mTc-FDPH46 SPECT/CT in malignant solid tumors (compared to the pathological gold standard). The main questions it aims to answer are: * What is the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors, compared to the pathological gold standard? * What is the biodistribution, tumor uptake and safety of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors? Participant Will: • Patients with clinically suspected or diagnosed malignant solid tumors who are willing to undergo 99mTc-FDPH46 SPECT/CT examination and sign an informed consent form.

A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors

This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors