Clinical trials

This study focuses on the treatment of liver metastases from three common cancers: colorectal cancer, triple-negative breast cancer and melanoma. Currently, there are limitations in the treatment of liver metastases of these cancers. Multimodal thermophysical ablation therapy can reshape the tumor microenvironment, release neoantigens, and act as an in-situ vaccine. On this basis, the combination of multimodal ablation with immunotherapeutic drugs such as pucotenlimab will be explored. The efficacy and safety of this combination therapy in patients with liver metastases of solid tumors will be investigated, with the expectation of breaking through the existing treatment limitations.

This is a prospective, Phase II, open-label, two-arm parallel study evaluating the efficacy and safety of combined treatment (L-Ornithine L-Aspartate, N-Acetylcysteine) with CDK4/6 inhibitors and Fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer (ABC) who have progressed on prior standard therapy including CDK4/6 inhibitors and endocrine therapy.

Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below 20%. As an effective modality for local disease control, local radiotherapy has no established optimal sequencing schedule when combined with systemic therapy. The timing of radiotherapy intervention may directly affect treatment efficacy, treatment tolerance and quality of life of patients. Several studies have explored the impact of radiotherapy timing in oligometastatic ESCC, yet substantial limitations persist in current evidence, resulting in a lack of unified guideline recommendations and wide heterogeneity in clinical practice. Most existing investigations are retrospective or small-sample prospective studies with high heterogeneity in study design, patient population selection and treatment regimens, yielding inconsistent conclusions that cannot support consistent clinical consensus. To clarify the impact of radiotherapy timing on clinical efficacy in oligometastatic esophageal cancer, the investigator designed the present clinical trial. This study aims to compare the efficacy and safety of concurrent radiotherapy versus sequential radiotherapy on the basis of immunochemotherapy among patients with oligometastatic ESCC, so as to fill the evidence gap in existing research.

Main objective: 1\. To compare the objective response rate (ORR) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer. Secondary objectives: 1. To compare the disease control rate (DCR), duration of continuous remission (DoR), progression-free survival (PFS) and overall survival (OS) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer. 2. To evaluate the safety and tolerability of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib.

This prospective, multicenter observational study included all patients with solid neoplasms who received treatment with immune checkpoint inhibitors (ICIs) in clinical practice, regardless of tumor type, tumor stage, type of immunotherapy, or treatment lines. This study aimed to assess the use, effectiveness, and safety of ICIs for solid neoplasms in real-world populations, which can provide insights into clinical decisions associated with the use of ICIs for the treatment of cancer patients in the real-world setting.

The purpose of this study is to evaluate the efficacy and safety of neoadjuvant radiation therapy in improving local-regional control and facilitating surgical conversion in patients with inoperable locally advanced breast cancer after 2-6 courses of neoadjuvant chemotherapy. This study will also investigate whether beta-alanine supplementation and spatially fractionated radiotherapy can enhance the therapeutic response to neoadjuvant chemoradiotherapy. In addition, this study aims to explore tumor microenvironmental features and molecular biomarkers associated with treatment response, radioresistance, immune activation, and long-term outcomes.

To evaluate the efficacy and safety of Culmerciclib combined with fulvestrant compared with investigator-selected CDK4/6 inhibitors combined with fulvestrant in patients with HR-positive/HER2-negative breast cancer who have progressed after first-line endocrine therapy

This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype. A total of 140 patients are planned to be enrolled.

This is a single-center, single-arm clinical study to evaluate the efficacy and safety of iparomlimab and tovorilimab (QL1706) combined with paclitaxel, carboplatin, and bevacizumab as neoadjuvant therapy for advanced ovarian cancer.

The main goal of this clinical trial is to learn if a new targeted cancer drug called sacituzumab tirumotecan (sac-TMT) works to treat cancer while causing less nerve damage in patients with advanced urothelial carcinoma who have progressed on or could not tolerate previous treatment such as enfortumab vedotin plus pembrolizumab (EVP) or disitamab vedotin plus toripalimab (DVT). The main question it aims to answer is: Does sac-TMT lower the risk of getting severe nerve damage, as measured together by doctors, machines, and the participants? Researchers will compare sac-TMT to alternative MMAE-based ADC drugs (switching to a different MMAE-based ADC after the first one stopped working) to see if sac-TMT causes less nerve damage while still effectively treating the cancer. A small group of participants who had to stop their previous MMAE-based ADC treatment because of nerve damage will also receive sac-TMT to learn if the drug is safe for their nerves. Participants will: 1. Receive either sac-TMT or another MMAE-based ADC drug 2. Have regular physical exams by a doctor to check their nerves 3. Have machine tests to measure how well their nerves work 4. Answer survey questions about their pain, numbness, and daily activities

This is an open-label, prospective, single-arm, multicenter phase II clinical trial. The aim is to explore the efficacy and safety of radiotherapy combined with cisplatin/carboplatin, adebrelimab, and bevacizumab in patients with triple-negative breast cancer and brain metastases.

This investigator-initiated study aims to evaluate the incidence and severity of cancer-related fatigue (CRF) in patients with malignant tumors, to analyze the influencing factors of CRF, and to explore its impact on anti-tumor treatment and prognosis.

Approximately 5-15% breast cancer patients develop brain metastases. Current local treatments (surgery/radiotherapy) are associated with significant complications, and systemic treatments have limited efficacy. Although new-generation ADC drugs, such as trastuzumab deruxtecan, have demonstrated breakthrough efficacy in patients with brain metastases, the mechanisms of action are not fully elucidated, moreover the current treatment regimens still have limitations for patients with HER2-low expressing, safer and more effective systemic treatment options are urgently needed to improve patient survival. BCBM-006 is an open-label, prospective, single-arm, single-center Phase II clinical study to evaluate the relationship between cerebrospinal fluid drug concentration and efficacy of trastuzumab deruxtecan in central nervous system metastatic breast cancer, and explore the incidence of leptomeningeal metastases diagnosed via lumbar puncture in patients with brain parenchymal metastases, facilitate early intervention to improve prognosis.

The goal of this observational study is to evaluate the feasibility and effectiveness of using non-contrast chest computed tomography scans for opportunistic breast cancer screening, and to further compare its diagnostic performance with conventional imaging modalities, including mammography and/or breast magnetic resonance imaging.

This study is a prospective, multicenter, phase Ⅲ trial to evaluate of the compression/ice gloves/socks efficacy in UTD1-induced peripheral sensory and motor neuropathy. 324 patients will be included. All patients will be randomly divided into three groups at a ratio of 1:1:1. Group A is the blank control group, group B is the compression glove/sock group, and group C is the ice glove/sock group.

The UNITY study is a prospective, single-arm, single-center, Phase II clinical trial conducted by Fudan University Shanghai Cancer Center. It aims to evaluate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) combined with ivonescimab in patients with hormone receptor-positive (HR+), HER2-negative recurrent or metastatic breast cancer. Approximately 53 patients will be enrolled. Eligible participants must have histologically confirmed advanced HR-positive breast cancer with HER2-low or HER2-ultralow expression. They must have experienced recurrence, metastasis, or disease progression after prior treatment with a CDK4/6 inhibitor (including in the adjuvant setting) and have received at most one line of systemic chemotherapy for advanced disease. The study permits the enrollment of patients with central nervous system (CNS) metastases. The primary endpoint is the Overall Response Rate (ORR). Key secondary endpoints include Clinical Benefit Rate (CBR), Overall Survival (OS), Progression-Free Survival (PFS), safety, and patient-reported quality of life (assessed using EORTC QLQ-C30 and QLQ-BR23). Exploratory endpoints will involve the analysis of biomarkers from tumor and blood samples, as well as PAM50 molecular subtyping and its correlation with survival outcomes. This study seeks to explore the efficacy and safety of Trastuzumab Deruxtecan in combination with ivonescimab for patients with HR-positive, HER2-negative recurrent or metastatic breast cancer, with a particular focus on the subpopulation with CNS metastases.

This study is a prospective clinical study enrolling breast cancer patients at high risk of chemotherapy-induced thrombocytopenia (CTIT). It aims to investigate the efficacy and safety of hetrombopag in the secondary prophylaxis of CTIT. Breast cancer patients with histologically or cytologically confirmed disease were enrolled after signing the informed consent form and were randomly assigned in a 1:1:1 ratio to three Arms. Stratification factors for randomization included the number of prior antineoplastic treatment cycles (\>2 cycles vs. ≤2 cycles). Arm 1: No prophylactic use of hetrombopag Arm 2: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle Arm 3: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle; Treatment continued until patients completed the protocol-specified treatment and follow-up, experienced intolerable toxicity, withdrew informed consent, initiated alternative antitumor therapy, died, or met any other treatment discontinuation criteria specified in the protocol, whichever occurred first.

A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS

This study aims to analyze the electroencephalographic power spectrum and connectivity during unresponsive states induced by propofol, esketamine and dexmedetomidine, respectively. It intends to explore the macro neural mechanisms underlying anesthetic unresponsiveness, so as to further elucidate the mechanisms by which anesthetics induce loss and recovery of consciousness. In addition, this study will identify neural biomarkers under general anesthesia for monitoring patients' actual intraoperative consciousness status. The findings will facilitate the development of monitoring indicators and devices reflecting intraoperative consciousness during general anesthesia, enabling more accurate assessment of patients' intraoperative consciousness status.

This randomized, double-blind, parallel-controlled trial aims to evaluate the effects of an indoor air purifier intervention on respiratory health in patients with Chronic Obstructive Pulmonary Disease (COPD).

The goal of this clinical trial is to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT) sequential capecitabine versus single-agent capecitabine as adjuvant intensified therapy in patients with high-risk early-stage triple-negative breast cancer (TNBC) without BRCA mutations. The main questions it aims to answer are: 1. Does sacituzumab tirumotecan (sac-TMT) sequential capecitabine improve survival outcomes compared with capecitabine monotherapy in this patient population? 2. What is the safety profile of sacituzumab tirumotecan (sac-TMT)-containing adjuvant therapy versus capecitabine monotherapy? Researchers will compare the sacituzumab tirumotecan (sac-TMT)-sequential-capecitabine experimental arm with the capecitabine-alone control arm to see if the experimental regimen provides superior adjuvant anti-tumor efficacy with acceptable safety. Participants will be randomized in a 1:1 to Receive assigned study treatment as follows: Experimental arm: Sacituzumab tirumotecan (sac-TMT) 4 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles, followed by sequential capecitabine at stratified doses; patients with prior PD-1/L1 inhibitor exposure will continue PD-1/L1 inhibitor therapy for up to 1 year Control arm: Capecitabine monotherapy at stratified doses; patients with prior PD-1/L1 inhibitor exposure will continue PD-1/L1 inhibitor therapy for up to 1 year

Colorectal cancer (CRC) ranks third in both incidence and mortality among all malignant tumors in China. Studies have shown that early screening can significantly reduce its incidence and mortality. Colonoscopy is the gold standard for CRC screening; however, compliance with colonoscopy among high-risk groups in China is very low. Artificial intelligence (AI)-assisted tools can provide real-time, personalized health education, and nudge strategies can help translate intent into action. This trial aims to evaluate the effectiveness of AI-empowered nudge for improving colonoscopy uptake among high-risk individuals aged 45 to 74 in China. It's a two-arm, pragmatic cluster randomized controlled trial. The main question it aims to answer is whether the AI-enabled personalized health education and nudge strategies improve colonoscopy adherence. Participants will: 1. Be recruited and allocated into one of two groups according to the assigned clusters. Participants in one group will be invited to receive usual care. In addition to usual care, participants in the other group will receive AI-empowered nudge, featuring an AI chatbot providing real-time personalized responses and a nudge environment with default screening option. 2. Have their colonoscopy status checked at the end of trial.

Based on the above situation, the investigators propose the following scientific hypothesis: In young patients with early MMRd type EC, the use of immune checkpoint inhibitors combined with progesterone for fertility retention therapy can improve the therapeutic efficacy, reduce recurrence, and improve tumor prognosis. Based on the above assumptions, this project intends to conduct a prospective exploratory clinical study in EC patients limited to the endometrial layer or superficial myometrium (FIGO 2023 IA1-IA2 stage). The subjects were treated with TQB2450 periodic intravenous drip + high-potency progesterone daily oral therapy. During the treatment period, hysteroscopy was performed every 12 weeks to evaluate the therapeutic efficacy. The primary endpoint was the 12-week CR rate; the secondary endpoints included the 24-week CR rate, the 36-week CR rate, the median CR time, the 1-year relapse rate, the 2-year relapse rate, the median relapse time, the pregnancy rate, the live birth rate, and drug-related adverse reactions. The exploratory indicators were the response of different MMRd tumors to immune checkpoint inhibitors and their possible mechanisms. The development of this study will provide a clinical basis for improving the fertility-preserving treatment regimen of MMRd EC.

To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA/MPA) alone as fertility-sparing treatment for patients with early endometrial carcinoma.

The goal of this observational study is to describe the clinical epidemiological characteristics and disease spectrum distribution of newly diagnosed primary lung cancer patients in a real-world setting. The main questions it aims to answer are: What is the current status of lung cancer epidemiology, including age, gender, smoking history, and pathological subtype distribution? How do different lung cancer screening behaviors (e.g., overscreening, underscreening, guideline-concordant, and precision screening) influence the capture rate of the "curative time window" (defined as adenocarcinoma in situ (AIS)/minimally invasive adenocarcinoma (MIA) or pure Ground-Glass Nodules (GGNs) stage)? What are the economic costs and cumulative radiation exposure associated with these different screening patterns? Researchers will compare these screening behavior groups to evaluate the efficacy of the "low-age, low-frequency" screening strategy in capturing early-stage lung cancer. Participants will be asked to: Provide their medical history and detailed records of pre-diagnosis lung cancer screening (including CT scan history). Allow researchers to collect and analyze their clinical, pathological, and radiological data from hospital records and medical databases. Complete a questionnaire regarding their screening history and health-related behaviors.