Clinical trials

This is a prospective, multicenter, single-arm, phase II clinical study designed to explore the efficacy and safety of zanidatamab in combination with liposomal irinotecan and capecitabine as second-line therapy for HER2-positive advanced biliary tract cancer. Fifteen patients with unresectable locally advanced or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer, will be enrolled after progression on or intolerance to first-line therapy. HER2 positivity must be confirmed by immunohistochemistry and/or fluorescence in situ hybridization, defined as IHC 3+ or IHC 2+ with FISH-confirmed amplification. Zanidatamab 20 mg/kg will be administered intravenously on Day 1 every 2 weeks; liposomal irinotecan 50 mg/m² will be administered intravenously over 90 minutes on Day 2 every 2 weeks; and capecitabine 1,000 mg/m² will be administered orally twice daily on Days 1-10 of each 14-day cycle. Chemotherapy will be administered for a maximum of six cycles, and study treatment will continue until disease progression or unacceptable toxicity. The primary endpoint is objective response rate, as assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety.

This study will look at whether adding daily oral zinc supplements to targeted therapy plus immunotherapy may help people with unresectable or advanced hepatocellular carcinoma, a common type of liver cancer. About 60 participants will take part in this study. Participants will be randomly assigned to one of three groups. One group will receive targeted therapy plus immunotherapy without extra zinc. The other two groups will receive the same type of cancer treatment together with either 20 mg or 30 mg of elemental zinc each day. The main goal is to compare how many participants have their tumors shrink or disappear by Week 18. Researchers will also look at tumor response at earlier time points, how long the cancer remains under control, overall survival, and treatment safety. Blood tests will be used to measure zinc and copper levels during the study. Researchers will also study changes in immune cells, including T cells, to better understand whether zinc supplementation may affect the body's immune response to cancer treatment. This study is designed to explore whether oral zinc supplementation is safe and may improve the effects of targeted therapy plus immunotherapy. The results may help determine which zinc dose should be studied in larger clinical trials.

The purpose of this study is to construct and validate a multimodal survival prediction model by integrating 3D radiomics features derived from preoperative magnetic resonance imaging (MRI) with systemic clinical baseline indicators for patients with colorectal liver metastases (CRLM) after surgery. By combining micro-level radiomics signatures reflecting tumor micro-heterogeneity with macro-level clinical parameters (such as liver function and tumor biomarkers), the study aims to accurately evaluate individual post-operative prognostic risks. This quantitative tool will provide reliable decision support for clinicians to customize post-operative follow-up and personalized adjuvant treatment strategies.

This prospective, single-center, single-arm, phase II study will evaluate perioperative adebrelimab in patients with locally advanced cervical cancer. Approximately 35 participants will receive three 3-week cycles of neoadjuvant adebrelimab in combination with paclitaxel and cisplatin or carboplatin. Participants without disease progression who are considered resectable will undergo radical hysterectomy and pelvic lymph node dissection 28-42 days after the last cycle of neoadjuvant treatment. Postoperative treatment will be risk-adapted according to pathological risk factors. Participants with high-risk pathological factors will discontinue protocol treatment and receive standard concurrent chemoradiotherapy. Participants with intermediate-risk factors will receive guideline-recommended pelvic radiotherapy plus adebrelimab maintenance, whereas low-risk participants will receive adebrelimab maintenance. Adebrelimab maintenance will be administered every 3 weeks for up to 1 year and may be discontinued early after two consecutive negative circulating tumor HPV DNA tests at least 3 months apart. The primary endpoint is the pathologic complete response rate. Secondary endpoints include objective response rate, disease control rate, disease-free survival, 2-year disease-free survival rate, overall survival, duration of response, quality of life, and safety. Dynamic circulating tumor HPV DNA will also be explored as a biomarker of treatment response and postoperative recurrence risk.

This multicenter retrospective cohort study aims to evaluate the prognostic value of functional liver volume and total liver volume in patients with unresectable hepatocellular carcinoma (HCC) undergoing immunotherapy. The study explores whether baseline liver volume metrics can effectively predict survival outcomes and treatment responses in this patient population to assist in clinical decision-making.

This prospective observational study will evaluate whether changes in circulating tumor human papillomavirus DNA (ctHPV-DNA) after radical surgery can help predict the risk of recurrence in patients with HPV-associated cervical cancer. Blood samples will be collected before surgery and at two predefined postoperative time points. The first postoperative assessment (TP#1) will be performed 2-4 weeks after surgery and, for patients scheduled to receive adjuvant therapy, before the start of adjuvant treatment. The second assessment (TP#2) will be performed 12-16 weeks after surgery or, for patients receiving adjuvant therapy, 12-16 weeks after completion of adjuvant treatment. Among patients who are ctHPV-DNA negative at TP#1, the study will compare those who remain negative at TP#2 with those who become ctHPV-DNA positive. The primary objective is to determine whether postoperative ctHPV-DNA dynamics are associated with disease-free survival and whether ctHPV-DNA provides additional prognostic information beyond conventional pathological risk factors. Adjuvant treatment will not be assigned by the study and will be determined according to standard clinical guidelines, pathological risk factors, and multidisciplinary clinical assessment. The study will also explore whether ctHPV-DNA may help identify patients who could benefit from treatment escalation or, conversely, patients at sufficiently low risk who may be candidates for future treatment de-escalation strategies.

The primary objective is to investigate the correlation between specific patterns of γδ T cell reconstitution after umbilical cord blood transplantation and key clinical outcomes.

Intrapartum Ultrasound-Guided Early Manual Rotation for Correcting Abnormal Fetal Head Position The goal of this clinical trial is to learn whether using ultrasound during labor, followed by early manual rotation of the baby's head when needed, can help more women give birth vaginally when the baby's head is facing an unfavorable direction. During labor, most babies turn so the back of the head faces the front of the mother's pelvis. This position usually makes birth easier. Some babies remain in a back-facing or side-facing position, called occiput posterior or occiput transverse position. These positions may make labor longer and may raise the chance of assisted vaginal birth or cesarean birth. In this study, trained midwives or obstetric clinicians will use intrapartum ultrasound, which is an ultrasound scan during labor, to check the baby's head position. Ultrasound is non-invasive and can give a clearer and more objective picture than examination by touch alone. If the baby's head is in an unfavorable position and the participant meets the study safety criteria, the clinician may try manual rotation. Manual rotation means using the hand to gently help turn the baby's head into a more favorable front-facing position. Researchers will compare two groups. One group will receive ultrasound-guided early manual rotation when the cervix is about 5 to 7 centimeters open and the baby's head is low enough. The other group will receive usual labor care, including standard examinations and usual clinical management. Participants will be assigned to one of these groups by chance, like flipping a coin. The main question is: Does ultrasound-guided early manual rotation increase the chance of vaginal birth? The study will also learn about safety and other birth outcomes, including whether the baby's head turns successfully, how long labor lasts, whether forceps or cesarean birth is needed, bleeding after birth, fever or possible infection, perineal injury, the mother's birth experience, breastfeeding, and newborn outcomes such as Apgar score, umbilical cord blood pH, need for resuscitation, birth injury, or admission to the neonatal intensive care unit. Participants will: * Have eligibility checked during labor. * Have an ultrasound scan to check the baby's head position. * Be randomly assigned to one of the study groups if they meet the study criteria. * Continue to receive close labor monitoring, including fetal heart rate monitoring. * Have birth and newborn information collected from medical records. * Complete follow-up after birth, including up to 42 days after delivery. Possible benefits include a better chance that the baby's head turns to a favorable position, a higher chance of vaginal birth, and fewer complications related to prolonged or difficult labor. These benefits are not guaranteed. Possible risks include discomfort or pain during manual rotation, failed rotation, temporary fetal heart rate changes, vaginal or cervical injury, bleeding, or the need for urgent clinical care, including cesarean birth. The study team will stop the procedure and provide standard care if there are safety concerns. Taking part is voluntary. A participant may choose not to join or may leave the study at any time. This will not affect the usual care provided to the mother or baby.

Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia

To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)

This multicenter, prospective, single-arm study evaluates a novel streamlined pathway for men at high risk of clinically significant prostate cancer (csPCa) identified by the USTC model (probability ≥0.60). Under general anesthesia, participants undergo MRI/ultrasound fusion targeted biopsy; the cores are immediately analyzed by frozen section hematoxylin-eosin staining and rapid immunohistochemistry. If csPCa is confirmed intraoperatively, laparoscopic radical prostatectomy is performed during the same anesthesia session. The primary aims are to determine the diagnostic concordance between intraoperative rapid pathology and definitive paraffin pathology, the positive surgical margin rate at 12 months, and perioperative safety. The study enrolls 150 participants across 12 Chinese hospitals and is expected to provide evidence supporting an efficient, PET-independent, one-stage diagnostic-therapeutic strategy for clinically significant prostate cancer.

This is a single-arm, early safety and feasibility exploratory study to evaluate the efficacy and safety of MegaLT Injection in promoting platelet recovery after umbilical cord blood transplantation. Adults with malignant hematologic diseases who undergo umbilical cord blood transplantation will receive a single intravenous infusion of MegaLT Injection on day 14 after transplantation. Two dose levels will be evaluated sequentially, and platelet recovery, platelet transfusion requirements, and safety outcomes will be assessed.

This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of low-dose versus standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) for the prevention of Pneumocystis jirovecii pneumonia (PJP) in kidney transplant recipients. Participants will be randomly assigned to receive either low-dose or standard-dose TMP-SMX for 12 months after kidney transplantation. The primary outcome is the incidence of PJP during the prophylaxis period. Secondary outcomes include adverse events related to TMP-SMX, dose reduction or discontinuation rates, incidence and timing of PJP after discontinuation, and other post-transplant complications. Participants will be followed for a total of 24 months, including a 12-month prophylaxis period and an additional 12-month follow-up period after discontinuation. This study aims to provide evidence for optimizing prophylactic strategies against PJP in kidney transplant recipients.

This study is led by the Department of Hepatobiliary Surgery of the First Affiliated Hospital of the University of Science and Technology of China (USTC), in close collaboration with multiple participating centers nationwide. The primary objective is to establish a standardized, large-scale clinical cohort database specifically for metastatic liver cancer. By collecting comprehensive data on patient demographics, primary tumor characteristics, systemic therapies, and local interventions, this registry aims to elucidate the clinical patterns and prognostic factors of secondary liver malignancies. This database will serve as a robust platform for conducting high-quality real-world studies and advancing evidence-based clinical research in the management of metastatic liver cancer.

A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate injection once a day,from the 1st to the 5th day after the operation. Compared with the monotherapy regimen of no liver protection treatment before the operation and receiving magnesium isoglycyrrhizinate injection 100mg once a day from the 1st to the 5th day after the operation.The efficacy and safety of treating postoperative liver function injury in patients undergoing laparoscopic hepatectomy for hepatocellular carcinoma were compared.

This is a single-center, prospective, open-label, single-arm phase I exploratory study designed to evaluate the safety and feasibility of a novel central immune-priming radiotherapy strategy in patients with unresectable stage III non-small cell lung cancer (NSCLC). The investigational approach consists of a single 8 Gy/1 fraction radiotherapy dose delivered to the central subregion of the primary tumor, with rapid dose fall-off to keep the peripheral tumor margin dose below 4 Gy, followed by one cycle of PD-(L)1 inhibitor, and then standard concurrent chemoradiotherapy (cCRT) approximately one week later. Patients without disease progression after cCRT will subsequently receive consolidation immune checkpoint inhibitor therapy. The primary objective is to assess the safety and feasibility of this lead-in immune-priming strategy, particularly whether it can be integrated into standard cCRT and subsequent immunotherapy without unacceptable toxicity or treatment delay. The primary endpoint is the dose-limiting toxicity (DLT) rate, with the DLT observation window defined from initiation of the priming radiotherapy to 6-8 weeks after completion of cCRT. Secondary objectives include the on-time initiation rate of cCRT, cCRT completion rate, initiation rate of consolidation immunotherapy, acute and subacute toxicity profile, preliminary efficacy signals, and dynamic changes in peripheral lymphocyte counts. Exploratory analyses will investigate peripheral immune cell subsets, circulating tumor DNA (ctDNA), T-cell receptor (TCR) clonality, cytokine changes, and their associations with toxicity and clinical outcomes. The study will adopt a safety run-in plus expansion design, with an initial cohort of 6 patients and expansion to 24 patients if safety is acceptable.

A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD

This study is a multicenter, randomized controlled trial aimed at evaluating the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients who have suffered moderate to severe acute brain injuries complicated by hypoproteinemia. Eligible participants, aged 60 and older, with acute brain injuries and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone. Clinical data will be collected at baseline and weekly for four weeks. The primary outcome measure will be the change in plasma albumin levels from baseline to Week 2. Secondary outcome measures will include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rates, hemoglobin levels, length of hospital stays, length of intensive care unit stays, and functional outcomes. Safety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence that can help optimize nutritional support and rehabilitation strategies for elderly patients with acute brain injuries.This study is a multicenter, randomized controlled clinical trial designed to evaluate the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients with moderate to severe acute brain injury complicated by hypoproteinemia. Eligible participants aged 60 years and older with acute brain injury and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone. Clinical data will be collected at baseline and weekly for four weeks. The primary outcome is the change in plasma albumin level from baseline to Week 2. Secondary outcomes include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rate, hemoglobin level, length of hospital stay, intensive care unit stay, and functional outcomes. Safety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence for optimizing nutritional support and rehabilitation strategies in elderly patients with acute brain injury.

The purpose of this prospective, multi-center randomized controlled trail is to compare the safety and efficacy of sequential surgery or staged surgery in patients with skull defect and hydrocephalus. The main observation will be the occurrence of complications such as postoperative infection, reoperation, shunt tube obstruction, hematoma, and subdural effusion. This will provide high-quality evidence for clinical selection of appropriate strategies.The concurrent surgery group needs to complete the VPS and CP in the same operation, and the sequence of the surgeries is determined based on the patient's condition and is recorded.However, the staged surgery group requires two surgeries, with an interval of 2 to 8 weeks and the operation order is determined by randomization.Within 1 week after surgery, participants should cooperate to monitor vital signs, assess neurological function ( such as GCS、GOS, etc.), conduct head CT examinations regularly to observe the postoperative intracranial condition, and record the occurrence of postoperative complications.Postoperative follow-up should last for at least 6 months.Outpatient or telephone follow-ups should be conducted at 1 week, 1 month, 3 months, and 6 months after the surgery.During each follow-up, a neurological function assessment and quality of life score (such as the SF-36 Health Survey) should be completed, and the occurrence of postoperative complications should be recorded.

This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed/refractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19 gene injection

To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with malignant hematologic diseases after single-unit unrelated cord blood transplantation (sUCBT).

Renal transplantation is the most ideal and effective treatment for end-stage renal disease. Pneumocystis jirovecii pneumonia (PJP) is one of the most common pulmonary infections after renal transplantation, with high morbidity and mortality that seriously affects patients' prognosis and survival. PJP can be prevented with drugs, and trimethoprim-sulfamethoxazole (TMP-SMX) is the first-choice prophylactic agent. However, there is no clear definition of the prophylactic course of TMP-SMX in domestic and international guidelines. Most of the prophylactic durations for PJP are based on the clinical experience of physicians, ranging from 6 to 12 months across different transplant centers. Multiple studies have shown that some patients still develop PJP more than one year after renal transplantation. Previous research by our team found that PJP has a peak incidence around 9 months after renal transplantation, with a second peak occurring between 10 and 15 months. This study aims to adopt a single-center, randomized, parallel-controlled trial design, planning to enroll 450 patients after renal transplantation. It will investigate the impact of different prophylactic courses of TMP-SMX on the incidence of PJP, and explore whether long-term prophylaxis is more reasonable and effective than short-term prophylaxis. Meanwhile, during follow-up, the peak serum concentration of SMZ in patients will be measured to analyze the relationship between SMZ serum concentration and the occurrence of PJP as well as adverse reactions. A clinical prediction model will be constructed to reveal the effective concentration range of TMP-SMX for prophylactic use. This will further optimize the prophylactic regimen, provide practical guidance for clinical practice, reduce the morbidity and mortality of PJP, and improve prognosis.

To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years

This study is a single-center, prospective, double-blind, randomized controlled clinical trial (RCT). Employing a parallel-group design, the trial plans to enroll 30 clinically diagnosed AD patients, who will be randomly assigned via a computerized randomization tool into three equal groups: low-dose, high-dose, and control (10 patients per group). The blinded clinical trial consists of three phases: \*\*Screening Phase\*\*: All enrolled patients must provide fully informed consent and meet inclusion criteria while avoiding exclusion criteria. Baseline assessments will be recorded, and single-cell omics samples will be collected. Patients may voluntarily opt for cerebrospinal fluid (CSF) sampling. The umbilical cord blood (UCB) used clinically is sourced from the Shandong Cord Blood Hematopoietic Stem Cell Bank. Following erythrocyte and granulocyte depletion via lymphocyte separation and density gradient centrifugation, the UCB is purified to reduce immunogenicity and undergoes genetic screening to exclude the APOE4 risk allele. \*\*Treatment Phase\*\*: In addition to standard care, patients will receive intravenous infusions at weekly intervals for four sessions. A fifth infusion will be administered one month after the fourth. The low-dose group receives 1×10⁸ UCB-derived mononuclear cells (UCB-MNCs) per infusion, the high-dose group receives 3×10⁸ UCB-MNCs, and the control group receives an equivalent volume of saline placebo. All clinically administered UCB-MNCs undergo genetic screening to exclude the APOE4 risk allele. \*\*Follow-up Phase\*\*: Assessments will be conducted at 30 days (1 month), 60 days (2 months), 90 days (3 months), and 180 days (6 months) post-initial infusion, including: 1. CDR-SB scale scoring; 2. Total and subdomain scores of the Activities of Daily Living (ADL) scale; 3. Serum inflammatory cytokines (IL-1, IL-2, IL-6, IL-8, IL-10, TNF-α), AD biomarkers (P-tau181, P-tau217), and other relevant markers; 4. Single-cell omics sample collection; 5. Optional CSF sampling per patient preference. After database lock, unblinding will occur for subsequent analysis.

In the era of immunotherapy, the standard second-line treatment regimen for locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced/metastatic ESCC. The study plans to enroll 37 patients who have failed first-line treatment, without grouping, all of whom will receive Ivonescimab combined with short-course hypofractionated radiotherapy. The primary endpoints are progression-free survival (PFS) and safety, while the secondary endpoints include overall survival (OS), duration of response (DOR), and objective response rate (ORR). The study duration is 2 years.