Clinical trials

The goal of this clinical trial is to learn if a family-physician nudge intervention works to improve influenza vaccination among adults aged 55 years and older in China. Three independent, parallel cluster randomized controlled trials will be conducted under three distinct vaccine payment policies, i.e. free vaccination for those older than 65 years and self-paid vaccination for those \<65 years in rural areas, and partially insurance-covered vaccination in urban areas. The main questions it aims to answer are: 1. Does the family-physician nudge intervention increase influenza vaccination uptake among older adults? How does the effectiveness of the nudge intervention vary under different payment policies？ 2. Is the family-physician nudge intervention cost-effective, acceptable, feasible, and potentially sustainable in primary care settings? Researchers will compare an intervention group receiving a family-physician nudge with a control group receiving routine care to see if the nudge is effective at increasing influenza vaccination among older adults. Participants will: 1. Be recruited at community health service centers and cluster-randomized by their family physicians into one of two groups. 2. Receive either a physician nudge (provider recommendation by an endowment-framing educational pamphlet + default appointment + a follow-up reminder) or routine health education. 3. Have their influenza vaccination status verified through the immunization information system at the end of the trial.

Peripheral arterial disease can reduce blood flow to the legs. This study will examine how blood flow patterns in the leg arteries differ between people with peripheral arterial disease and people without the disease. Researchers will use existing computed tomography angiography (CTA) images and medical records from participants who previously received CTA as part of routine clinical care. Three-dimensional models of the leg arteries will be created from these images. Computer simulations will then be used to study how changes in blood flow entering the arteries and resistance in smaller downstream blood vessels affect blood flow patterns. The researchers will compare these responses between participants with and without peripheral arterial disease. This study uses only existing medical records and images. No new participants will be recruited, and no additional examinations or treatments will be performed for research purposes. The goal is to better understand blood flow characteristics associated with peripheral arterial disease.

This study aims to investigate vaccine-related knowledge, attitude, vaccine confidence and vaccine hesitancy among MSM across multiple countries and regions.

The goal of this clinical trial is to evaluate whether an AI-assisted primary care intervention for parents can increase RSV monoclonal antibody (mAb) uptake among infants, and to assess the cost-effectiveness and potential for implementing the intervention in routine primary care. The main questions it aims to answer are: 1. Does the RSV AI-assisted primary care intervention increase parents' perceived risk of RSV disease, RSV prevention literacy, confidence in using RSV mAb, willingness to use RSV mAb for their infants, and RSV mAb uptake among infants? 2. Is the AI-assisted primary care intervention acceptable, feasible, and potentially sustainable for RSV prevention? 3. Is the AI-assisted primary care intervention cost-effective compared with conventional health education, and what factors may facilitate or hinder its implementation? Researchers will compare parents of infants who receive the RSV AI-assisted primary care intervention with those who do not receive it to determine whether the intervention improves parents' literacy, confidence, and willingness to use RSV mAb and increases RSV mAb uptake among their infants. Participants will: 1. Be recruited and randomly assigned to the intervention group or control group. Participants in the intervention group will have access to an AI assistant for RSV mAb-related health information and get a RSV mAb recommendation from primary care physicians, while participants in the control group will receive routine health education. 2. Complete a survey questionnaire assessing parents' perceived risk of RSV disease, RSV prevention literacy, confidence in using RSV mAb, and willingness to use RSV mAb for their infants. 3. Have their infants' RSV mAb uptake assessed at the end of the trial.

This investigator-initiated, single-center, randomized, open-label, phase II trial will evaluate the efficacy and safety of intensified adjuvant SHR-A1811 compared with trastuzumab plus pertuzumab in women with initially stage IIB-IIIC HER2-positive early breast cancer who achieved pathologic complete response after neoadjuvant systemic therapy and have detectable postoperative circulating tumor DNA (ctDNA). Eligible participants will be randomized 1:1 and stratified by hormone receptor status, HER2 test category, and initial clinical anatomic stage. The primary endpoint is invasive disease-free survival.

This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant endocrine therapy in breast cancer.

This prospective, multicenter, single-arm phase II interventional study evaluates whether longitudinal circulating tumor DNA (ctDNA) monitoring can guide neoadjuvant immunotherapy and surgical decision-making in dMMR/MSI-H colon cancer. Participants with ctDNA clearance proceed to curative surgery, whereas those with persistent ctDNA positivity escalate to combined PD-1 and CTLA-4 inhibitor therapy.

This study is a Phase III non-inferiority trial targeting a specific subset of early breast cancer patients: those with HR-positive/HER2-negative, node-negative small tumors (typically ≤2cm) but who exhibit high-risk features for recurrence (such as high histological grade, high Ki-67 index, etc.). Currently, the standard adjuvant treatment for these patients often includes chemotherapy followed by endocrine therapy, despite their small tumor size, due to the high-risk biological characteristics. However, chemotherapy can bring significant toxicity and long-term side effects. This trial explores whether a chemotherapy-sparing approach is feasible. It compares the efficacy and safety of using the CDK4/6 inhibitor Dalpiciclib combined with endocrine therapy (AI ± OFS) directly, without chemotherapy, against the traditional approach of chemotherapy (TC regimen) followed by endocrine therapy. The primary goal is to demonstrate that the chemotherapy-free regimen is not inferior to the chemotherapy-containing regimen in terms of 5-year invasive disease-free survival (iDFS). If successful, this study could potentially de-escalate treatment for this high-risk population, sparing them from chemotherapy-related toxicities while maintaining excellent oncological outcomes.

RECLAIM: A Phase II, Open-Label, Single-Arm, Multicenter Clinical Trial of Cromolyn, TQB2102, and Panpulimab for Re-Challenging Immune-Refractory Triple-Negative Breast Cancer

This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year.

This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis

A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Bevicizumab in HER2-low breast cancer with brain metastasis.

This study will evaluate the efficacy and safety of cryoablation combined with Anlotinib plus TQB2868 in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.

This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery.

This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.

Background Clinical N3 (cN3) breast cancer represents a high-risk subgroup of locally advanced disease. After neoadjuvant systemic therapy (NST), patients who achieve a clinical complete response (cCR) in initially involved but undissected nodal stations currently receive a boost to these regions as part of standard postoperative radiotherapy. However, whether this boost is necessary in this setting remains unknown, and prospective evidence on the safety of boost omission is lacking. Objective The REACT-N3 trial aims to evaluate whether omitting the boost to undissected nodal stations that achieve cCR after NST is non-inferior to standard boost in terms of 3-year invasive breast cancer recurrence-free interval (IBCRFI), while reducing toxicity to adjacent organs. Methods This is an open-label, multicenter, randomized phase 3 trial. Eligible patients are women with cN3 breast cancer who have completed NST, undergone breast/axillary surgery with the internal mammary, supraclavicular, and infraclavicular nodes left undissected, and have no macroscopic residual disease in these stations on post-NST \[¹⁸F\]FDG PET-CT or other imaging. Participants will be randomized 1:1 to receive either a standard boost (10 Gy in 5 fractions) or no boost to the initially involved but cCR-converted undissected nodal stations. Randomization is stratified by postoperative axillary nodal status (ypN- vs. ypN+), location of the involved nodal station (SCV vs. non-SCV), and molecular subtype (TNBC vs. non-TNBC). The primary endpoint is 3-year IBCRFI. Secondary endpoints include locoregional recurrence-free survival, distant metastasis-free survival, disease-free survival, overall survival, toxicity, and patient-reported outcomes. With a non-inferiority margin of 8%, a one-sided α of 0.05, 80% power, and 10% drop-out rate, a total of 534 patients will be enrolled. Discussion The REACT-N3 trial will provide high-level evidence on the safety of boost omission in cN3 breast cancer patients with cCR after NST. If non-inferiority is confirmed, this strategy could establish a new, toxicity-sparing standard for regional nodal irradiation in this high-risk population.

This study will evaluate the efficacy and safety of cryoablation combined with QL1706 (iparomlimab/tuvonralimab) plus lenvatinib in patients with advanced biliary tract cancer (BTC) who have progressed after first-line treatment.

The study evaluates the combination of immunotherapy of PD-1/ CTLA4 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1/ CTLA4 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

This open-label, multicenter, randomized controlled trial involved 196 patients with pathologically confirmed, previously untreated, resectable MSI-L or MSS/pMMR ultra-low rectal adenocarcinoma. Patients were randomly assigned (1:1) to two groups to receive concurrent chemoradiotherapy followed by 4-6 cycles of chemotherapy ± tislelizumab. After treatment, patients who achieved complete clinical response (cCR), including those who reached pCR after local excision, or near cCR with pCR after local excision, were recommended to continue with 4-2 cycles of chemotherapy ± tislelizumab, followed by a watch-and-wait approach. Patients evaluated as incomplete responders were recommended for total mesorectal excision (TME) surgery. The primary endpoint is the anus preservation rate, while secondary endpoints include CR rate, 1-year/2-year/3-year organ preservation rates, 1-year/2-year/3-year EFS rates, and 1-year/2-year/3-year OS rates, etc.

Penile cancer is a rare malignant tumor of the male genitourinary system, with 95% being squamous cell carcinoma. Due to social factors, delayed diagnosis is common, leading to a high rate of lymph node metastasis (17%-45% at diagnosis), which significantly impairs quality of life and prognosis. The 5-year survival rate is 27% for patients with lymph node metastasis and 0%-17% for those with pelvic lymph node metastasis (N3). Current standard treatments recommended by guidelines include surgery and chemotherapy. However, the neoadjuvant TIP regimen (paclitaxel + ifosfamide + cisplatin) in locally advanced disease yields an objective response rate (ORR) of 50%, pathological complete response (pCR) rate of 10%, median progression-free survival (PFS) of 8.1 months, and median overall survival (OS) of 17.1 months. For advanced patients, no standard effective treatments exist after platinum-based chemotherapy resistance, highlighting an urgent need for more effective combination therapies. High expression of PD-L1 (30%-70%) and EGFR (40%-80%) is common in penile squamous cell carcinoma, especially in poorly differentiated, late-stage disease with lymph node metastasis. A prospective phase II study showed that toripalimab (immunotherapy) combined with nimotuzumab (anti-EGFR antibody) and paclitaxel-based chemotherapy, followed by consolidation surgery, achieved an ORR of 82.8%, pCR rate of 48.3%, 2-year OS rate of 72.4%, and 2-year PFS rate of 65.5%; 41.4% of patients had grade 3-4 treatment-related adverse events, with no treatment-related deaths. Although immune checkpoint inhibitors and anti-EGFR targeted therapy demonstrate preliminary antitumor activity in advanced penile cancer, their clinical efficacy remains suboptimal with substantial toxicities, thus warranting the development of more effective combinatorial therapeutic strategies.

This study is a prospective, open-label, multicenter, single-arm Phase II clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \>65 years) with lymph node-positive, HR+/HER2- breast cancer.

To evaluate the clinical efficacy (objective response rate, ORR) of mass spectrometry-based absolute quantification-guided selection and matching of ADC/PDC therapy in patients with locally advanced or metastatic pancreatic cancer/breast cancer, and to explore a quantitative threshold-based stratification strategy for identifying a "hidden benefit population

This national multicenter, randomized controlled clinical trial evaluates the safety and efficacy of consolidative stereotactic radiotherapy in patients with advanced EGFR-mutant non-small cell lung cancer who have oligo-residual disease after four cycles of first-line treatment with third-generation EGFR-TKI plus platinum-based pemetrexed chemotherapy. Eligible participants will be randomized 1:1 to continue third-generation EGFR-TKI plus pemetrexed maintenance therapy alone or to receive stereotactic radiotherapy to all oligo-residual lesions in addition to the same maintenance therapy. The primary endpoint is progression-free survival.

Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases. Methods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR/PR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR/PR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%. Wangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.