Clinical trials

The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-tumor activity of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer who have previously received systemic anti-cancer treatments. The main questions this study aims to answer are: What doses of metronomic oral paclitaxel solution can be safely administered to patients with advanced HER2-negative breast cancer? How well does metronomic oral paclitaxel solution control tumor growth? What side effects and treatment-related medical problems occur during treatment? This study will include two stages. In the first stage, researchers will evaluate different dosing schedules of oral paclitaxel solution to identify a dose（OTD） with an acceptable balance between safety and potential anti-tumor activity. In the second stage, additional participants will receive the selected dose（OTD） to further evaluate its effectiveness and safety. Participants will: Receive metronomic oral paclitaxel solution according to the assigned dose schedule. Visit the study clinic regularly for physical examinations, laboratory tests, tumor imaging assessments, and safety evaluations. Complete assessments of treatment response, side effects, and quality of life during the study. Continue follow-up after treatment to collect information about disease status and survival.

Primary Objectives： Evaluate the complete response rate (CR rate) and safety of short - course radiotherapy combined with ivonesimab (AK112) in patients with pMMR/MSS mid - low rectal cancer. Secondary Objectives： Evaluate treatment - related toxic reactions, the quality of life, long - term prognosis (local control \[LC\], disease - free survival \[DFS\] and overall survival \[OS\]). Patients will : Receive Radiotherapy: Pelvic IMRT or VMAT, DT 25Gy/5Fx. One week after radiotherapy, begin treatment with Ivorsimab (AK112) at a dose of 20mg/kg by intravenous drip on day 1. One cycle is 21 days, and a total of 6 cycles are to be carried out. Evaluate the curative effect after 3 cycles of treatment. Patients with progressive disease (PD) will withdraw from the study, and other treatment plans will be adjusted in a timely manner. Patients with CR/PR/SD will continue treatment for another 3 cycles. Conduct a comprehensive assessment after 6 cycles of treatment. Patients who achieve cCR can choose the watch - and - wait approach. For patients who do not achieve cCR, TME surgery is recommended. Decide whether to perform adjuvant chemotherapy based on the postoperative pathological findings.

This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients with unresectable intrahepatic cholangiocarcinoma. Approximately 140 eligible patients with histologically confirmed unresectable intrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled and randomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib or GEMCIS plus tislelizumab. In the TACE-based treatment arm, hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to the protocol. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, time to progression, objective response rate, disease control rate, safety, and quality of life.

This study explores the therapeutic effect of carbon ion radiotherapy plus immunotherapy and chemotherapy for locally advanced cervical cancer.

This is a Phase Ib/II study to evaluate the safety, tolerability and efficacy of IBI343 in combination with chemotherapy in patients with advanced pancreatic cancer, including a Phase Ib safety introduction and Phase II expansion phase. In phase Ib (safe introduction phase), participants with CLDN18.2-positive advanced pancreatic adenocarcinoma (PAC) who had previously received first-line gemcitabine-based systemic therapy were enrolled to receive IBI343 in combination with chemotherapy.A classic "3+3" dose-escalation design was used to determine the dose of the combination therapy, including the following two cohorts: Cohort A: received IBI343+ capecitabine TBD mg/m2 BID PO×14d Q3W; Cohort B: received IBI343+ capecitabine TBD mg/m2 BID PO×14d Q3W+ oxaliplatin TBD mg/m2 IV Q3W (each subject received up to 8 cycles of oxaliplatin). In cohort A, 3 subjects were enrolled in Intravenous (IV) Q3W, and the starting dose of IBI343 was 6 mg/kg.The preset starting dose of capecitabine was 750mg/m2 BID PO, D1-14, Q3W. The observation period of safe introduction of DLT was 21 days (3 weeks) after the first administration, and IBI343 was administered only once during the DLT observation period.If the first 3 subjects did not develop DLT during the DLT observation period, 3-6 subjects were allowed to receive IBI343 6mg/kg combined with capecitabine 1000mg/m2 BID PO, D1-14, Q3W;If DLT occurs in 1 of these 3 subjects, the other 3 subjects will be included in the same dose group.If no DLT occurred in the three additional subjects, 3-6 subjects were allowed to receive IBI343 6mg/kg combined with capecitabine 1000mg/m2BID PO, D1-14, Q3W;If DLT occurred in ≥1 of the 3 subjects included in the supplement, or ≥2 of the 6 subjects in total, or ≥2 of the first 3 subjects, 3 to 6 subjects were allowed to receive IBI343 4.5mg/kg Q3W;If intolerance remains, the mode and dose of administration will be further discussed. If the dose level of 1000mg/m2 in combination with capecitabine is confirmed to be safe, subjects in combination with capecitabine 750mg/m2 are allowed to increase the dose of capecitabine to 1000mg/m2 in subsequent cycles. If IBI343 combined with capecitabine is tolerated according to the above safety introduction rules, the safe introduction of IBI343 in cohort B (IBI343 combined with oxaliplatin and capecitabine) is initiated after the dose of IBI343 combined with capecitabine is determined.The preset starting dose of oxaliplatin in cohort B was 75mg/m2 IV D1 Q3W, and A preset climbing dose level of 100mg/m2 IV D1 Q3W was introduced in the same way as in cohort A.If both dose levels of oxaliplatin are not tolerated, the administration mode and dose will be further discussed, such as downregulating the administration dose of IBI343. The sponsor is allowed to adjust the safe dose of IBI343 based on the results of the preliminary study. To allow sponsors to further explore the dose of combination chemotherapy based on the observed safety during the Phase Ib safety introduction phase. Each cohort will enter the Phase II expansion phase of the cohort after safety introduction, determination of the combination dose and safety of IBI343. Participants enrolled in the expansion phase are consistent with those enrolled in the safety introduction phase, i.e., CLDN18.2-positive advanced PAC subjects who have previously received first-line gemcitabine-based systemic therapy: Phase II Cohort A: Approximately 32 subjects (including Phase Ib Cohort A dosing subjects) were scheduled to receive IBI343+ capecitabine Q3W. Phase II Cohort B: Approximately 24 subjects (including Phase Ib Cohort B dosing subjects) were scheduled to receive IBI343+ capecitabine + oxaliplatin Q3W.Each subject received a maximum of 8 cycles of oxaliplatin therapy. Queue A and queue B are expanded sequentially. Queue A is expanded first. After queue A is expanded, queue B is expanded.The investigator may also terminate the expansion of a cohort based on early efficacy and safety data, in which case only one of the cohorts should be expanded. Sponsors and funders are allowed to adjust the CLDN18.2 expression level requirements of enrolled subjects based on the results of other trials of IBI343. Subjects will continue to receive treatment until disease progression, toxicity intolerance, withdrawal of informed consent, loss of follow-up, death, or any other reason for discontinuation of study therapy (whichever occurs first). After discontinuation of study treatment, participants will be followed up for safety and survival. During the study, participants were evaluated by imaging according to RECIST v1.1. In the oxaliplatin combination cohort, oxaliplatin was used for a maximum of 8 cycles, and subjects in this cohort could continue maintenance therapy with IBI343+ capecitabine after oxaliplatin withdrawal.

This study aims to develop an AI-based predictive tool to help clinicians more accurately determine whether breast cancer patients can benefit from HER-2-targeted antibody-drug conjugate (T-DXd) therapy before treatment. While HER-2-targeted ADC drugs have significantly improved outcomes for patients with HER-2 positive and low-expression advanced breast cancer, there are notable individual differences in efficacy. Currently, there is a lack of precise clinical methods to predict response, which means some patients might receive ineffective treatment and face unnecessary drug side effects and financial burden. This study is a retrospective multicenter observational study, planning to collect pathological images (including HE staining and HER-2, ER, PR, Ki-67 immunohistochemical staining), proteomics data, and clinical efficacy information from HER-2 positive and low-expression advanced breast cancer patients who have received T-DXd treatment. The research will be carried out in five phases: 1. Build a clinical database for ADC drug therapy, integrating basic patient information, treatment plans, efficacy data, and pathology specimen information from multiple centers. 2. Use LC-MS/MS proteomics technology to screen for key protein markers related to T-DXd efficacy and use bioinformatics analysis to identify predictive protein indicators. 3. Extract IHC staining features from pathological images and evaluate their correlation with efficacy alongside clinical data. 4. Integrate proteomics, pathology, and clinical big data, using AI technologies such as foundational pathology models (like TITAN), biomedical large language models (like BioBERT), and protein large language models (like ESM2-15B). Apply a multiple instance learning strategy to build a multimodal efficacy prediction model, and evaluate the model's performance on the training set using 5-fold cross-validation. 5. Establish an internal validation cohort (200 cases) and a multicenter external validation cohort (300 cases). Considering that the external validation group may lack proteomics data, the multimodal model will be fine-tuned and distilled into a simplified predictive model based on standard IHC features (HER-2, ER, PR, Ki-67, plus key protein markers identified from proteomics) and clinical text information, then its performance will be verified in the external cohort. Ultimately, this research will create an AI tool to support clinical decision-making, promoting personalized treatment for HER-2 positive and low-expression breast cancer and the clinical adoption of AI in healthcare.

Primary Objective of this study: To investigate the correlation between longitudinal quantitative dynamics of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA) in peripheral blood and clinical prognosis among patients with recurrent and metastatic cervical cancer who achieved complete response following standard first-line systemic therapy.

The goal of this clinical trial is to evaluate the biodistribution, radiation dosimetry, safety, and time-dependent image quality of \^68\^Ga-EV203 injection in patients with hematological malignancies (multiple myeloma, non-Hodgkin lymphoma, or acute myeloid leukaemia), aged 18-75 years, who are able to lie still for 0.5 h and have no contraindications (e.g., pregnancy, recent radiotherapy, etc.). The main questions it aims to answer are: What are the biodistribution (organ uptake, %ID, SUV) and radiation absorbed doses (mGy/MBq) of \^68\^Ga-EV203 in target organs and the whole body? What is the safety profile of \^68\^Ga-EV203, as measured by adverse events and serious adverse events? How does the PET/CT image quality differ between the 30-, 60-, 90-, and 120-minute time points after injection? If there is a comparison group: Researchers will compare the positive percent agreement (PPA) and positive predictive value agreement (PPrA) of \^68\^Ga-EV203 PET/CT against \^18\^F-FDG PET/CT to see if the new tracer offers comparable or superior diagnostic performance in detecting CXCR4-positive lesions. Participants will: Receive a single intravenous injection of 74-296 MBq of \^68\^Ga-EV203. Undergo whole-body PET/CT scans at 30 min, 60 min, 90 min, and 120 min post-injection on the same day. Return within 3-7 days (but at least 2 days later) for a standard \^18\^F-FDG PET/CT scan after fasting for ≥5 h. Attend a safety follow-up visit at day 8-14 for physical examination, vital signs, and laboratory tests (blood count, coagulation, and biochemistry).

Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis. This observational study is to evaluate the safety and efficacy of senaparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment。

This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.

This is a prospective, multicenter Phase 2 clinical trial named the MALT-RO study, evaluating ultra-low-dose radiation therapy followed by orelabrutinib as first-line treatment for adults with Stage I-II MALT lymphoma. The study aims to determine the efficacy and safety profile of this sequential regimen. Eligible participants aged 18 years or older with histologically confirmed MALT lymphoma, measurable lesions, no prior systemic anti-lymphoma therapy, adequate organ function, and an ECOG performance status of 0-1 will receive 4Gy ultra-low-dose radiation (2Gy daily for 2 consecutive days) followed by oral orelabrutinib 150mg once daily for up to 6 cycles (28 days per cycle). Patients with partial response or stable disease after 6 cycles may continue orelabrutinib monotherapy for up to 12 cycles or until disease progression. All participants will undergo regular safety monitoring, tumor assessments, and long-term follow-up every 3 months to evaluate treatment durability. This treatment strategy is designed to improve efficacy and achieve more favorable outcomes compared with standard approaches for MALT lymphoma, while minimizing treatment-related toxicities such as long-term organ damage, xerostomia, cataracts, and other complications related to conventional standard-dose radiation, thereby offering a well-tolerated, convenient, targeted therapeutic option for patients with MALT lymphoma under strict ethical oversight in accordance with the Declaration of Helsinki and Chinese Good Clinical Practice guidelines.

This study is a prospective, single-center, open-label, single-arm clinical trial to assess the safety and efficacy of umbilical cord blood in cancer treatment-induced thrombocytopenia (CTIT) patients. It plans to recruit subjects aged 12 to 65 years old with CTIT. The study involves intravenous infusion of umbilical cord blood, with platelet transfusion as supportive therapy if necessary. The trial consists of three phases: screening (baseline assessments and enrollment), treatment (umbilical cord blood infusion), and follow-up (blood routine tests at Days 3, 7, 14, and 28 post-treatment to record platelet counts, first response time, maximum and minimum values, and calculate efficacy rates while observing changes in thrombocytopenia grading). A total of 25 subjects will be enrolled, and they will undergo evaluation for safety and efficacy based on treatment-related adverse events, GVHD incidence, and hematological improvements.

Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X

This study adopts a multicenter, natural selection, observational design, and plans to enroll patients with HER-2 positive advanced or metastatic breast cancer treated at approximately 20 research centers nationwide. Patients with de novo stage IV disease or those with recurrent metastatic breast cancer who have not previously received trastuzumab, as well as patients with brain metastases, will be included for separate stratified efficacy analysis and will not be included in the overall analysis. The study plans to enroll effective data from 600 HER-2 positive advanced or metastatic breast cancer patients, who will be naturally allocated in a 1:1 ratio to either Group A (switching from HP + chemotherapy to HPy + chemotherapy) or Group B (switching from HPy + chemotherapy to HP + chemotherapy), with each group comprising approximately 300 patients. If first-line treatment fails, patients will switch to the alternative regimen in second-line treatment. All patients will continue treatment until disease progression, intolerable toxicity, or other reasons lead to discontinuation, with the number of treatment cycles recorded. The study is divided into three phases: screening/baseline period, treatment period (treatment period 1 + treatment period 2), and survival follow-up period. If patients develop intolerance to taxanes during treatment, clinicians may select alternative chemotherapy regimens such as vinorelbine, capecitabine, or eribulin based on clinical judgment. During the treatment period, patients will be followed up every two cycles, during which clinical data will be collected, including disease status assessments, laboratory tests, study drug usage, concomitant medications, and adverse events. After chemotherapy completion or treatment discontinuation, subsequent maintenance therapy, such as continued dual-targeted maintenance, may be administered by clinicians based on clinical needs until disease progression or intolerable toxicity occurs. Survival follow-up will be conducted every three months (for up to three years), with patient survival status recorded.

This is a prospective, single-Arm, phase II clinical study evaluating the efficacy and safety of thiotepa in combination with pirtobrutinib (a BTK Inhibitor) and sintilimab (a PD-1 Inhibitor) for frail or relapsed/refractory primary or secondary central nervous system lymphoma.It includes screening phase， induction therapy phase, and maintenance therapy phase.The screening period is defined as within 14 days prior to the first dose.Induction Treatment Phase: Enrolled subjects will receive a combination regimen of thiotepa, pirtobrutinib, and sintilimab. Treatment is administered in 21-day cycles for up to 6 cycles. Patients who achieve a disease response may proceed to consolidation therapy with either autologous hematopoietic stem cell transplantation or whole-brain radiotherapy at the investigator's discretion.Maintenance Treatment Phase: For patients who do not receive consolidation therapy with autologous transplantation or whole-brain radiotherapy, maintenance treatment with pirtobrutinib plus sintilimab will be initiated (for up to 1 year). Patients who receive any consolidation therapy will not proceed to maintenance treatment.Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria. The trial will monitor patient survival data, objective response rate (ORR), and safety parameters.Upon discontinuation of study treatment or completion of the 1-year treatment period, subjects will enter the follow-up phase. During follow-up, radiographic assessments (contrast-enhanced CT of the involved site is recommended) will be performed according to the following schedule: every 3 months for the first 2 years, every 6 months from Year 3 to Year 5, and annually after 5 years, until the end of the follow-up period. For subjects who have not withdrawn consent, survival information (including date and cause of death, subsequent anti-tumor therapies, etc.) will be collected every 3 months via telephone and/or clinical visit.

To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.

This is a prospective, open-label, multi-center, single-arm clinical trial

* This study was an open, multicenter phase II clinical trial that enrolled 118 patients with HR+/HER2- with recurrent or progressive advanced breast cancer treated with CDK4/6 inhibitors; * The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continued to enter Phase 2 if no more than 3 patients achieved objective response. In Phase 2, qualified patients were randomly assigned at a ratio of 1:1.5 to either the entestasta + fluvestrus group (Group 1) or the anlotinib + entestasta + fluvestrus group (Group 2), with 39 patients enrolled in group 1 and 59 patients enrolled in group 2; All patients were treated until the subjects' treatment would continue until the subjects experienced disease progression, intolerable toxicity, active withdrawal from treatment, or other conditions specified in the protocol, whichever occurred first. * During the study period, efficacy evaluations will be conducted every 8 weeks in accordance with the Solid Tumor Efficacy Evaluation Criteria (RECIST) v1.1 until disease progression, the initiation of a new anti-tumor treatment by the subject, or the withdrawal of informed consent, whichever occurs first. * Continuous safety evaluations will be conducted during the study treatment period. All subjects who have received at least one study treatment will be required to undergo end-of-treatment visits and safety follow-up visits within 7 days and 30±2 days after the last study treatment, respectively. * The end of the study was defined as the occurrence of disease progression or the end of the study treatment in all subjects, or the early termination of the study for other reasons, whichever occurred first.

This is a phase 2 study designed to evaluate the safety and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) or S-1 and oxaliplatin (SOX) in perioprative treatment of locally advanced MHC-II-negative gastric and gastroesophageal junction adenocarcinoma.

Study Objective: To Evaluate the Efficacy of Albumin-Bound Paclitaxel Combined with Nedaplatin via Hepatic Arterial Infusion as Later-Line Therapy for Breast Cancer Patients with Liver Metastases After Failure of Standard Treatment. Outcome Measures：Primary Outcome: Liver Progression-Free Survival (LPFS) Secondary Outcomes:Liver Objective Response Rate (LORR)、Progression-Free Survival (PFS) and Overall Survival (OS) Participants will: * Albumin-bound paclitaxel + nedaplatin (TP) regimen is administered via hepatic arterial infusion chemotherapy on Day 1 of each cycle. * Tumor response will be assessed every 6 weeks (±7 days) according to RECIST 1.1 criteria until disease progression is determined by the investigator.

Ovarian cancer exhibits the highest mortality rate among gynecological malignancies. Currently, the combination of paclitaxel and carboplatin remains the standard first-line chemotherapy regimen for neoadjuvant or postoperative treatment of ovarian cancer. However, conventional paclitaxel, due to the addition of polyoxyethylated castor oil solubilizer, may induce various adverse reactions beyond chemotherapeutic toxicity, such as hypersensitivity, toxic renal injury, neurotoxicity, and cardiovascular toxicity. Therefore, exploring optimized treatment regimens to provide patients with new therapeutic options is imperative. HER2 is a protein encoded by the ERBB2 gene that regulates cell survival, proliferation, and differentiation. HER2 gene amplification and/or protein overexpression are observed in 18%-35% of mucinous ovarian cancers. A meta-analysis involving over 5,000 ovarian cancer cases revealed that HER2 overexpression correlates with reduced overall survival (OS) and progression-free survival (PFS), suggesting its potential as a biomarker for poor prognosis. The emergence of novel antibody-drug conjugates (ADCs) has brought new hope for anti-HER2 therapy in ovarian cancer, such as Disitamab Vedotin (RC48). Preliminary results from the PRaG3.0 trial presented at the 2023 ASCO Annual Meeting showed an ORR of 66.7% in six HER2-expressing gynecological cancer patients treated with RC48 combined with radiotherapy and immune checkpoint inhibitors (ICIs). Updated data from the RC48-C018 study demonstrated an ORR of 36.4%, median duration of response (mDoR) of 5.52 months, mPFS of 4.37 months, and 12-month OS rate of 66% in 22 cervical cancer patients. RC48 exhibited promising efficacy and manageable safety in recurrent/metastatic HER2-expressing (IHC 1+/2+/3+) cervical cancer. Regarding safety, the GOG-158 study reported pronounced hematologic toxicity with carboplatin-paclitaxel in advanced ovarian cancer: grade 3/4 leukopenia (\>50%), thrombocytopenia (\>30%), and neutropenia (\>80%). Conversely, a retrospective study of RC48 combined with platinum ± bevacizumab in HER2-mutated NSCLC patients showed an ORR of 71.4% with no dose reductions or discontinuations due to adverse events. Thus, RC48-platinum combinations may offer a lower-toxicity alternative. Thus the investigators designed this trial to evaluate the efficacy and safety of RC48 combined with carboplatin in HER2-expressing advanced ovarian cancer.

Laryngeal masks are core devices for supraglottic airway management, and the accuracy of their anatomical position directly impacts ventilation safety and the incidence of complications. Despite their wide clinical application, gaps remain in understanding their in vivo anatomical characteristics. This study aims to evaluate the in vivo anatomical features (e.g., insertion depth, anatomical alignment, tissue compression) of three laryngeal masks (LMA Supreme, I-gel, GMA-Tulip) using CT scanning in anesthetized patients undergoing CT interventional therapy, providing anatomical evidence for optimized laryngeal mask selection and complication prevention.

The integrity and functional stability of pharyngolaryngeal anatomical structures are critical for airway management, and the dynamic changes of key structures (e.g., pyriform sinus, cricoid cartilage lamina) during swallowing directly relate to the design and clinical safety of laryngeal masks. This observational study aims to investigate the real-time dynamic changes and physiological movement patterns of normal pharyngolaryngeal structures during barium swallow using routine barium meal examination imaging. The findings will provide anatomical and physiological evidence for optimizing laryngeal mask design and improving its anatomical fit with the pharynx and larynx.

Researchers will use LCMS Metabolic Analysis to Explore the Effect of American Ginseng on Urine and Plasma in Healthy Individuals Participants will: * Take 3 grams of American Ginseng powder every day for 14 days * Collect the fasting urine samples at the following times at the hospital: On the first day, on the 7th day after taking the medicine, and on the 14th day after taking the medicine. * Collect the fasting Serum samples at the following times at the hospital: On the first day and on the 14th day after taking the medicine. * Have their any adverse effects monitored and evaluated throughout the study.

A randomized, multicenter, Phase III trial evaluating the efficacy and safety of first-line Sequential AG-mFOLFOX chemotherapy combined with Serplulimab and Bevacizumab versus AG chemotherapy alone in advanced pancreatic cancer. The primary endpoint is Overall Survival (OS). Approximately 292 patients will be enrolled in China.