Clinical trials

This study aims to systematically evaluate the safety and efficacy of different early urinary catheter removal strategies following radical resection of mid-low rectal cancer. Current clinical practice faces controversy regarding the optimal timing of catheter removal (24 hours vs. 48 hours) and lacks precise preventive measures for patients at high risk of postoperative acute urinary retention (AUR). To address these issues, this study is designed as a three-arm randomized controlled trial, directly comparing three management protocols: catheter removal at 24 hours postoperatively, catheter removal at 48 hours postoperatively, and urinary catheter removal within 24 hours combined with prophylactic tamsulosin. The primary endpoint is the rate of recatheterization within 7 days after the initial removal, with secondary endpoints comprehensively assessing urinary tract infections, voiding function, and postoperative complications. The ultimate goal is to provide high-quality evidence-based medical evidence to establish a precise and standardized clinical pathway for postoperative catheter management.

This single-center, stratified randomized double-blind trial tests tegileridine, a new pain drug, for pain relief after weight-loss surgery. Researchers will compare tegileridine with standard opioid pain medicine. Eligible patients having bariatric surgery will be randomly assigned to one of the two treatment groups. Patients and study teams will not know which treatment each participant receives. Participants will be grouped based on whether they have obstructive sleep apnea (OSA). The primary measurement is postoperative recovery quality in the first 24 hours after surgery using the QoR-15 survey. The study will also track pain scores, rescue pain medication use, and drug side effects for 7 days after surgery. There is no guaranteed benefit for participants. Study pain medicines may cause side effects. Doctors will provide rescue treatment for uncontrolled pain.

This prospective observational cohort study aims to characterize feeding intolerance in critically ill adult patients and to identify clinical, physiological, laboratory, electrophysiological, and imaging factors associated with its development. Within 24 hours after intensive care unit (ICU) admission, participants undergo systematic multimodal assessment, including blood sampling, gastrointestinal electrophysiological measurements, gastric antral ultrasonography with assessment of antral motility, skeletal muscle ultrasonography, intra-abdominal pressure measurement, and collection of relevant clinical and laboratory variables. Participants are prospectively followed for the occurrence of feeding intolerance and other clinically relevant outcomes. The study will evaluate the incidence, predictors, and risk factors of feeding intolerance and explore whether multimodal measurements obtained within the first 24 hours after ICU admission can improve early prediction of feeding intolerance compared with conventional clinical variables. Additional outcomes include duration of organ support, ICU-free days, ventilator-free days, mortality at 28, 90, and 180 days, and longer-term health-related quality of life assessed using the EQ-5D-5L. The overall objective is to improve understanding of feeding intolerance in critically ill patients, enable early risk stratification, and provide a theoretical basis for future individualized nutritional assessment and management strategies.

The goal of this observational study is to evaluate the local efficacy and safety of hydrodissection-assisted microwave ablation for patients with hepatocellular carcinoma, and to compare its therapeutic outcomes with surgical resection for hepatocellular carcinoma. The main questions it aims to answer are: Is hydrodissection-assisted microwave ablation safe and effective for treating hepatocellular carcinoma? How does the therapeutic effect of hydrodissection-assisted microwave ablation compare with surgical resection for hepatocellular carcinoma? Patients who receive either microwave ablation or surgical resection will Undergo a 2-year follow-up period.

Melanoma has emerged as the fastest-growing malignancy in recent years, with incidence and mortality rates among both men and women in East Asian countries exceeding the Asian average. China ranks fifth among East Asian nations in melanoma incidence. Currently, immune checkpoint inhibitors are achieving significant breakthroughs in adjuvant melanoma therapy. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy alone in patients with PD-L1-positive, completely resectable mucosal melanoma, thereby providing additional clinical evidence for treatment decisions.

When the subjects are admitted to the department, the researchers will monitor potential biomarkers of gastrointestinal injury before administering enteral nutrition (a small amount of blood is drawn, serum is separated by centrifugation, and the serum sample is frozen for final centralized biomarker detection), and measure the antral movement index under ultrasound (300ml of warm water is injected into the stomach before measurement, and then the antral movement is observed for 6 minutes) Then, monitor whether the patient has developed feeding intolerance within 7 days of the ICU

Project Name: Improved Feeding Regimen for Critically Ill Patients (mNEED) Based on Feeding Intolerance Prediction Model Solution version number and version date: Version 5.0; 2024.12.16 Informed consent version number and version date: Version 1.0; 2023.10.19 Dear Patient, Recently, the department participated in a nationwide study to develop nutrition protocols for critically ill patients. Participation in a "Modified Feeding Regimen for Critically Ill Patients Based on a Predictive Model of Feeding Intolerance in Critically Ill Patients (mNEED): a multicenter, cohort randomized, controlled trial" is being invited. Before deciding whether to participate in the study, it is important to read the following information carefully to understand the clinical treatment study, its purpose, procedures, duration, and potential benefits, discomforts, and risks. If desired, the information can be discussed with relatives, friends, or the attending physician to assist in making an informed decision. For any questions, please direct them to the physician in charge of the study. I. Introduction of Clinical Trials Research Background and Purpose Leading international evidence-based guidelines consistently recommend early targeted nutritional therapy for critically ill patients. However, multicenter cluster-randomized controlled trials (cRCTs) evaluating the impact of implementing these guidelines have not demonstrated patient benefit. In 2022, Ke et al. proposed evidence-based Feeding Guidelines for Critically Ill Patients (NEED), which provided a specific feeding regimen for nutritional therapy in critically ill patients. The results suggested that the NEED group initiated enteral nutrition (EN) earlier and reduced the use of overall parenteral nutrition (PN). However, the NEED feeding strategies did not reduce the incidence of feeding intolerance in critically ill patients. In previous studies, a predictive model of feeding intolerance (NOFI) in critically ill patients was constructed, demonstrating good predictive power. Therefore, the NEED feeding program will be improved (mNEED) based on NOFI to reduce the occurrence of feeding intolerance (FI) while ensuring the nutritional needs of critically ill patients are met. Research Process Research Funds: All treatment methods involved in this study follow conventional treatment procedures, without additional interventions or charges. Study Content: This study is conducted by the Department of Intensive Care Medicine of the First Hospital of Jilin University, with 2,250 patients expected to be enrolled from ICUs in 90 hospitals nationwide. This study is a multicenter cluster randomized controlled trial, where each center is randomly divided into an experimental group and a control group. Data will be summarized and analyzed statistically. Possible Risks This study involves an improvement in the feeding strategy for critically ill patients and will not cause additional risks. In the event of serious gastrointestinal adverse events, symptomatic management will be provided promptly. Subject Benefits All participants in the study will be examined and treated by clinically experienced physicians, who will address questions and provide timely and thoughtful medical services. Participation may lead to improved conditions, and the results of this study may benefit other patients with similar conditions. Voluntary Participation and Withdrawal Before the trial, a detailed understanding of the clinical trial is encouraged. The hospital and the attending physician are obligated to provide information related to the clinical trial and address any concerns. Participation in the clinical trial treatment is voluntary. Duty of Confidentiality Medical records (including medical history, physical examination reports, and laboratory results) will be securely stored in the hospital. Access to these records will be limited to physicians (researchers), professional academic committees, ethics committees, and health supervision and management departments. Any public reporting of the study results will not disclose personal identities. Every effort will be made to protect the privacy of personal medical information to the extent permitted by law.

Siewert type II/III gastroesophageal junction (GEJ) adenocarcinoma is a challenging malignancy located at the anatomical transition between the esophagus and stomach. Due to its complex anatomical location and mixed biological characteristics of esophageal and gastric cancers, the optimal surgical strategy remains controversial. Current surgical approaches vary in terms of operative access, extent of resection, and lymph node dissection. Although minimally invasive laparoscopic and integrated robotic surgery have demonstrated potential advantages in improving perioperative outcomes, limitations remain when managing complex procedures involving both abdominal and mediastinal fields. Split-type robotic surgical systems, characterized by independently movable robotic carts, provide greater flexibility in robotic arm positioning and may overcome some limitations associated with conventional integrated robotic platforms, particularly in extensive multi-quadrant procedures requiring simultaneous abdominal and mediastinal lymph node dissection. However, clinical evidence regarding the safety and effectiveness of split-type robotic surgery for Siewert type II/III GEJ cancer remains limited. This prospective single-arm clinical study aims to evaluate the feasibility, safety, and short-term surgical outcomes of split-type robotic radical surgery for patients with Siewert type II/III GEJ adenocarcinoma. The study will assess perioperative outcomes, including operative characteristics, postoperative complications, lymph node dissection quality, and short-term recovery parameters. The findings of this study are expected to provide preliminary clinical evidence regarding the application of split-type robotic technology in complex GEJ cancer surgery and support future large-scale clinical investigations.

Gastric cancer ranks as the fifth most common malignancy worldwide and the fourth leading cause of cancer-related deaths. In China, its incidence and mortality rank third among all cancers. While the global incidence of gastric cancer is declining, proximal gastric cancer and adenocarcinoma of the esophagogastric junction (AEG) are on the rise. Due to the unique characteristics of AEG, there is no standardized treatment consensus, making the selection of an optimal surgical approach and reconstruction method crucial for improving patient outcomes. For early-stage proximal gastric cancer and AEG, total gastrectomy (TG) and proximal gastrectomy (PG) are common surgical options. PG, increasingly favored for its function-preserving benefits, has been shown to be a safe and effective alternative to TG. While TG effectively removes lymph nodes and reduces reflux risk, it leads to permanent loss of gastric function and nutritional deficiencies. PG better preserves gastrointestinal function but is limited by the risk of reflux esophagitis, highlighting the need for improved reconstruction techniques. Several reconstruction methods exist after PG, including esophagogastric anastomosis, jejunal interposition, double-tract reconstruction (DTR), double-flap technique (DFT), and tubular gastric anastomosis, each with varying efficacy in preventing reflux. Studies suggest that DTR reduces reflux and improves quality of life compared to esophagogastric anastomosis, while DFT, first introduced in 1998, has gained popularity for its advantages in maintaining nutrition and minimizing reflux. Additionally, tubular gastric anastomosis, which constructs a narrow gastric tube to facilitate tension-free anastomosis, has shown potential benefits for AEG patients. Most existing studies on laparoscopic or robot-assisted reconstruction techniques for proximal gastric cancer are retrospective, lacking high-quality prospective evidence. Furthermore, comparative data on their anti-reflux efficacy and postoperative quality of life remains l

Gastric cancer is the fifth most common malignancy and the fourth leading cause of cancer-related deaths. Surgical resection is the primary treatment, with laparoscopic-assisted gastrectomy (LG) being a minimally invasive option. However, LG is limited by restricted instrument mobility and hand tremors, which affect precision. The Da Vinci robotic system enhances surgical precision with 3D magnification, improved hand-eye coordination, tremor filtration, and flexible instruments. It is especially beneficial in complex procedures like D2 lymph node dissection and lower mediastinal lymph node clearance. Unlike laparoscopic surgery, robotic surgery offers superior flexibility and reduced pancreatic injury during dissection. Robotic-assisted gastrectomy (RG) offers advantages over LG, such as reduced blood loss, shorter hospital stays, and improved lymph node dissection. However, its short-term benefits remain debated, and most studies focus on early gastric cancer. The safety and efficacy of RG for advanced gastric cancer are not well-established. Vascular coagulation is crucial in minimally invasive surgery. Ultrasonic devices, though widely used, can cause thermal damage due to high temperatures. In contrast, the Vessel Sealer Extend (VSE) offers greater flexibility and precision. It allows 540° instrument rotation, coagulates vessels up to 7 mm in diameter with lower energy, and minimizes thermal injury. Retrospective studies show RG with VSE may have faster recovery and fewer complications than LG. However, further prospective, multicenter studies are needed to confirm these benefits for advanced gastric cancer. The investigators propose a multicenter, observational study to evaluate RG with VSE in advanced gastric cancer, assessing safety, recovery, and oncological outcomes.

This is a prospective, single-arm, single-center clinical study evaluating pomalidomide combined with rituximab as maintenance treatment in young high-risk patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) who have achieved at least a partial response after first-line therapy. Eligible participants will receive rituximab 375 mg/m² by intravenous infusion on Day 1 every 8 weeks and pomalidomide 4 mg orally once daily on Days 1 to 21 of each 28-day cycle. Maintenance treatment is planned for 24 months unless disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria occur. The main purpose of this study is to evaluate the efficacy and safety of this maintenance treatment approach. The primary outcome measure is the 1-year progression-free survival rate. Secondary outcome measures include conversion from partial response to complete response, duration of response, progression-free survival, overall survival, 1-year and 2-year overall survival rates, 2-year progression-free survival rate, minimal residual disease, complete molecular response, immune cell subsets, immune function markers, and adverse events.

Subcapsular hepatocellular carcinoma (HCC) has unique anatomical characteristics that may influence treatment selection and clinical outcomes. Surgical resection and liver transplantation are potentially curative treatments but may be limited by liver function, tumor characteristics, and perioperative risks. Microwave ablation has become an important minimally invasive treatment option for patients with HCC, particularly for lesions that are difficult to treat surgically. This prospective observational cohort study aims to compare the therapeutic efficacy, safety, and long-term outcomes of no-touch microwave ablation, tumor-puncture microwave ablation and surgical resection in patients with subcapsular HCC. Treatment outcomes, including local tumor control, treatment-related complications, recurrence, and survival outcomes, will be evaluated to provide evidence for individualized treatment strategies for patients with subcapsular HCC.

Gastric cancer is a common type of cancer that often spreads to the liver. When cancer spreads to the liver, treatment becomes very difficult. Many patients will undergo chemotherapy to shrink the tumor. Currently, doctors use CT or MRI scans to assess the effect of chemotherapy, but these examinations usually take about 2 months to show changes in the size of the tumor. The purpose of this study is to test whether a special type of ultrasound technology called "contrast-enhanced subharmonic ultrasound" can help doctors determine earlier whether chemotherapy is effective compared to conventional scans. This ultrasound detection does not use radiation and can display the blood perfusion status inside liver tumors. We will observe the changes in blood flow perfusion inside the tumor before the start of treatment and after 1-2 chemotherapy cycles to see if these changes can predict whether chemotherapy will be effective in the future. If this test is effective, it will help doctors adjust the treatment plan more quickly, which may improve the treatment effect for gastric cancer patients whose cancer cells have spread to the liver, and also help identify patients who are not responding to chemotherapy as early as possible, reducing the side effects and economic burden of patients.

Hepatocellular carcinoma (HCC) is the sixth most common malignant tumor worldwide, with a significantly increased incidence among patients with liver diseases. Even if HCC can be treated by surgical resection and ablation, the 5-year recurrence rate is as high as 50-70%. The Liver Imaging Reporting and Data System (LI-RADS), released by the American College of Radiology (ACR), is a classification management system specifically designed to evaluate liver lesions in high-risk HCC patients. Since its release in 2011, the CT/MRI LI-RADS has been updated to the 2018 version. Subsequently, the CEUS LI-RADS was introduced in 2016 and updated in 2017. The CEUS LI-RADS standard has relatively high specificity but lacks sensitivity. The ESCULAP (Erlanger Synopsis of Contrast-enhanced Ultrasound for Liver lesion Assessment in Patients at Risk) standard proposed by Schellhaas et al. in Germany has high sensitivity in diagnosing HCC in patients with liver diseases . However, there is currently a lack of research on the diagnostic efficacy of these two standards for the re-discovery of liver space-occupying lesions in patients with a history of HCC. This study aims to compare the diagnostic efficacy of the two standards for recurrent HCC in patients with a history of HCC.

This study aims to address the issue of a lack of individualized basis for selecting liver resection (LH) or microwave ablation (MWA) in early-stage hepatocellular carcinoma (HCC) patients to reduce the early recurrence rate (≤2 years). Given that existing machine learning-based recurrence prediction studies have failed to guide the optimal treatment plan selection, and that multidisciplinary consultations rely on guidelines (universality) and experience (subjectivity) which have their limitations, we propose to utilize artificial intelligence (AI), specifically the advantages of multimodal deep learning technology (which outperforms traditional machine learning by integrating complementary information to provide more accurate predictions), to establish a hybrid deep learning model that integrates contrast-enhanced ultrasound (CEUS) and enhanced magnetic resonance imaging (MRI) features. This model will predict the probability of early recurrence (ER≤2 years) in patients and, based on this, recommend LH or MWA as the optimal first treatment option for newly diagnosed early HCC patients to optimize individualized treatment decisions.

Colorectal cancer is a common type of cancer that often spreads to the liver. When cancer spreads to the liver, treatment becomes very difficult. Many patients will undergo chemotherapy to shrink the tumor. Currently, doctors use CT or MRI scans to assess the effect of chemotherapy, but these examinations usually take about 2 months to show changes in the size of the tumor. The purpose of this study is to test whether a special type of ultrasound technology called "contrast-enhanced subharmonic ultrasound" can help doctors determine earlier whether chemotherapy is effective compared to conventional scans. This ultrasound detection does not use radiation and can display the blood perfusion status inside liver tumors. We will observe the changes in blood flow perfusion inside the tumor before the start of treatment and after 1-2 chemotherapy cycles to see if these changes can predict whether chemotherapy will be effective in the future. If this test is effective, it will help doctors adjust the treatment plan more quickly, which may improve the treatment effect for colon cancer patients whose cancer cells have spread to the liver, and also help identify patients who are not responding to chemotherapy as early as possible, reducing the side effects and economic burden of patients.

This study plans to find the most suitable lymph node cortex thickness and abnormal lymph node features to define suspicious lymph nodes. Then, ultrasound-guided core needle biopsy of axillary lymph nodes will be done, aiming to provide some guidance for the biopsy.

To evaluate the diagnostic value of the combined model of subharmonic-assisted pressure estimation (SHAPE), liver stiffness (LSM), and platelet count (PLT) for high-risk esophageal and gastric varices (HRV)

This international multicenter retrospective cohort study aims to externally validate the URSL Predictive Angle, a novel CT-derived morphometric parameter, as an imaging biomarker for predicting intraoperative conversion risk during transurethral ureteroscopic lithotripsy (URSL) for ureteral calculi. Intraoperative conversion is defined as the unanticipated abandonment of the planned endoscopic approach due to unfavorable ureteral anatomy or stone impaction, necessitating recourse to open ureterolithotomy, laparoscopic ureterolithotomy, or ureteral stent placement with planned staged secondary intervention. Such conversions are associated with protracted operative duration, heightened anesthetic exposure, and increased physical, psychological, and financial burdens on patients. The URSL Predictive Angle is a geometric parameter derived from preoperative coronal CT reformations that quantifies the degree of local ureteral angulation induced by an impacted calculus. Preliminary single-center data demonstrated robust predictive fidelity of this metric with an area under the ROC curve of 0.861 and an optimal discriminatory threshold of 131.8° yielding a sensitivity of 82% and a specificity of 88%. This study will enroll eligible patients from multiple domestic and international tertiary care hospitals who underwent URSL for ureteral calculi between January 1, 2018, and December 31, 2025. The primary outcome is intraoperative conversion of surgical approach. The predictive performance of the URSL angle will be evaluated using ROC curve analysis with AUC calculation. Propensity score matching and multivariable logistic regression will be employed to address potential confounding. This study is registered as a patient registry with a cohort model. Data collection is retrospective, involving abstraction from electronic medical records, operative logs, and PACS. A waiver of informed consent has been requested based on the retrospective design, minimal risk determination, stringent anonymization procedures, and impracticability of obtaining individual consent.

This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continuous infusion combined with irinotecan hydrochloride liposome ± cetuximab/bevacizumab. Approximately 30 patients will be enrolled.

This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia.

Why is this study conducted? The purpose of this study is to improve the treatment efficacy, particularly the pathological complete response rate, in patients with high-risk/extremely high-risk locally advanced rectal cancer (LARC). In recent years, with the combination of neoadjuvant chemoradiotherapy and immunotherapy, some progress has been made in the treatment of rectal cancer, but there are still problems of regional recurrence and distant metastasis. Therefore, developing new treatment strategies for these patients is particularly important. The treatment of rectal cancer usually involves surgery, radiation therapy, and chemotherapy. The current treatment methods have gradually shifted towards neoadjuvant chemoradiotherapy combined with immunotherapy, and have shown good potential in some clinical trials. These studies suggest that combining short-range radiotherapy, anti angiogenic drugs, and immune checkpoint inhibitors may play an important role in improving patient prognosis and enhancing tumor response rates. However, the efficacy and safety of these plans in high-risk patients still need further validation. In this context, the aim of our study is to compare the efficacy and safety of neoadjuvant short-course radiotherapy followed by four cycles of CapeOX chemotherapy combined with toripalimab, with or without concurrent surufatinib, in patients with mid-to-low locally advanced rectal cancer with high-risk factors identified by MRI (including any one or more of the following: cT4, cN2, EMVI+, MRF/CRM+, or lateral lymph node metastas. This study aims to promote treatment optimization for LARC patients and provide new ideas for future treatments. Why are you invited to participate in this study? We would like to invite you to participate in this study as you have been diagnosed with high-risk or extremely high-risk locally advanced rectal cancer, which meets the inclusion criteria of this study. Specifically, you need to meet the conditions for pathological diagnosis, have a suitable tumor location, and not have serious comorbidities or other excluded diseases (such as recurrent rectal cancer, cardiac dysfunction, etc.). The final selection will be determined by the research doctor based on your actual situation. What do you need to do to participate in this study? Participating in this study will require you to follow a series of steps. You need to undergo regular medical examinations and evaluations, including blood tests, imaging examinations, and anorectal function assessments. During the research period, you may also need to fill out a questionnaire and provide some biological samples (such as blood samples), which will be used for the analysis of drug efficacy. The frequency and specific content of each follow-up will be informed by the research team to ensure your participation throughout the entire treatment process. I hope you can cooperate with these research steps to help us better understand the effectiveness of this treatment plan. What are the risks of participating in this study? This study involves the use of neoadjuvant short course radiotherapy, PD-1 monoclonal antibody (Terizumab), and anti angiogenic therapy (Sofantinib). Participants may face the following risks: Risk of neoadjuvant short course radiotherapy: Participants may experience severe side effects (≥ grade 3), including but not limited to severe diarrhea, third degree neutropenia, and third degree radiation dermatitis. These side effects may seriously affect the quality of life of patients. Risk of PD-1 monoclonal antibody: Terriptylimab may cause immune related adverse reactions (irAEs), which can involve any organ. The commonly known irAEs include skin toxicity (such as papules and itching, with an incidence of 30% to 40%), diarrhea and/or colitis (8% to 19%), fatigue (16% to 24%), immune related hepatitis (5%), hypothyroidism (4% to 10%), and hyperthyroidism (4%). Overall, nearly two-thirds (about 2/3) of patients receiving immune checkpoint inhibitor therapy will experience varying degrees of irAEs, and the incidence of serious adverse events cannot be ignored. Risk of anti angiogenic therapy: The use of sorafenib may lead to adverse reactions related to its anti angiogenic and immunomodulatory effects. Known common adverse reactions include proteinuria, hypertension, bleeding, liver dysfunction, diarrhea, etc., with an incidence rate of over 20%. Among serious adverse events (≥ grade 3), hypertension (29.7%), proteinuria (14.5%), liver dysfunction (12.8%), and bleeding (4.5%) are the most common. In rare cases, treatment-related deaths may occur due to gastrointestinal bleeding, cerebral hemorrhage, etc. Handling of research related injuries? This study is an intervention study that does not add any additional risks beyond routine clinical diagnosis and treatment. If you suffer harm due to participating in the study, compensation or liability will be determined in accordance with relevant laws and regulations.

Imaging evaluation was performed every 3 months (± 7 days) from enrollment, and real-time examination was performed if new lesions were suspected. The study was divided into two parts: Part 1: Rexiacin capsules assist in the treatment phase of the TC regimen. Part 2: Rexiacin capsule combined with targeted drug maintenance therapy after the end of chemotherapy. The overall research cycle is roughly divided into screening period, treatment period, and follow-up period: Screening period: -7d\~0d, that is, after the signing of the informed consent form, the screening assessment must be completed within 7 days; Treatment period: 1 dosing cycle every 3 weeks; During chemotherapy, blood routine, liver and kidney function tests were performed every week, tumor marker monitoring and safety evaluation were performed every cycle, and imaging evaluations were performed every 3 months (± 7 days) to evaluate the efficacy. After the end of chemotherapy, the maintenance treatment period and follow-up stage will be conducted, and biochemical tests such as tumor markers, blood routine, liver and kidney function will be performed every 3 months (± 7 days), and imaging evaluation will be performed to evaluate the efficacy, and the patient's self-evaluation results will be evaluated (FOSI, EQ-5D-5L). Peripheral blood immune indicators: Peripheral blood TBNK+Treg lymphocyte subset typing and activated lymphocyte cytokines were performed every 6 months (± 7 days) to monitor the patient's immune status. Medication is administered until an event that meets the criteria for treatment termination occurs or the clinical trial is closed. Clinical tumor imaging evaluation was completed (the evaluation method was consistent before and after, enhanced CT or enhanced MRI was preferred). Investigational drug treatment should be continued until the occurrence of disease progression, or withdrawal due to intolerable toxicity, or receipt of new anti-tumor therapy, or withdrawal of informed consent and voluntary withdrawal for other reasons, or study termination, whichever occurs first. The termination time of the study is the last subject who has received the study drug for 1 year or all subjects are out of the group, whichever is achieved first. Follow-up period: If the investigator decides to end the subject's treatment with the study drug, then the treatment period will be considered the end of (End of Therapy, EOT). All subjects, including those who discontinue treatment for any reason (except for loss to follow-up, death, withdrawal of informed consent), will have an EOT visit scheduled within 7 days after the investigator decides to end the subject's treatment with study drug. The EOT visit should include vital signs, physical examination, laboratory tests, and clinical tumor imaging evaluation (first enhanced CT or enhanced MRI). Safety follow-up: Subjects are required to have a safety visit 30 days (+7 days) after the last dose. If the subject plans to receive a new anti-tumor treatment within 30 days after the last dose, a safety follow-up will be conducted before receiving the new anti-tumor therapy. Safety visits are required at the study center and should be performed to assess for AEs, concomitant medications, and concomitant treatments. Until adverse reactions related to the study drug disappear, or drop to Grade ≤1, or return to baseline levels, or stable or acceptable levels assessed by the investigator. Survival follow-up: After the safety follow-up, subjects will be followed up for survival once every 3 months (± 7 days), and will be followed up by telephone until death, loss to follow-up, withdrawal of informed consent, or termination of the study.

This trial was designed as a single-arm, open-label, prospective clinical trial to evaluate the efficacy (ORR) and safety (AE incidence) of CapsuleX in combination with cisplatin for platinum-resistant recurrent ovarian cancer (PROC).

The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection