Clinical trials

The purpose of this study is to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma. Patients will be randomized 1:1 etither to receive hepatic arterial infusion(HAI) Adabrelimab group or IV Adabrelimab group, and both groups will receive HAI FOLFOX chemotherapy and IV Bevacizumab.

This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.

For Patients and Families Brief Title: Management of 1L Lorlatinib with Hyperlipidemia in ALK+ Advanced NSCLC What is this study about? This study is for people with ALK-positive non-small cell lung cancer (NSCLC) who are taking lorlatinib (Lorbrena®) as their first treatment and have developed high cholesterol (hyperlipidemia) as a side effect. Why is this study needed? Lorlatinib is a highly effective targeted therapy, but it frequently causes elevated cholesterol and triglycerides. There is currently no standard guideline on how to best manage this side effect. This study aims to find the best approach to control lipid levels while on lorlatinib treatment. What will happen in this study? The study has two parts: * Part A (Observational) : About 100 participants. Doctors manage hyperlipidemia according to routine clinical practice. Researchers simply observe and record which lipid-lowering treatments are used and how well they work. * Part B (Randomized Controlled Trial) : 60 participants with high-risk factors are randomly assigned to either: * Intensive treatment: rosuvastatin + ezetimibe + evolocumab * Standard treatment: rosuvastatin + ezetimibe What tests are involved? * Blood tests for lipid levels at baseline, Weeks 4, 8, 20, and 24 * Routine CT or MRI scans for tumor assessment * Some participants in Part B may have a non-invasive vascular ultrasound (FMD) test * Total participation per patient: up to 7 months Is this study safe? * ✅ Approved by the Ethics Committee of Sun Yat-sen University Cancer Center * ✅ All drugs used (lorlatinib, statins, ezetimibe, evolocumab) are already approved and widely used * ✅ An independent Data Monitoring Committee (DMC) monitors safety throughout the study * ✅ Participants may withdraw at any time without affecting their regular care For Healthcare Providers Study Title: Management strategy of 1L Lorlatinib with Hyperlipidemia in Stage IIIB-IV ALK positive NSCLC: A multi-center prospective study in China Sponsor / Investigators: Sun Yat-sen University Cancer Center (PI: Prof. Zhang Li) Study Type: * Part A: Observational, prospective, real-world cohort study * Part B: Prospective, randomized controlled trial (RCT) Estimated Enrollment: 160 participants (Part A: \~100, Part B: 60) Study Duration: Approximately 4 years (anticipated completion: December 2029) Key Inclusion Criteria: * Stage IIIB-IV ALK+ NSCLC (confirmed by IHC, FISH, PCR, NGS, or ctDNA) * No prior systemic therapy for advanced/metastatic disease * ECOG PS 0-2 * Age ≥ 18 years * Hyperlipidemia (ULN ≤ TC \< 12.93 mmol/L, Grade 1-3) while on first-line lorlatinib * At least one measurable lesion per RECIST v1.1 * Life expectancy ≥ 6 months Primary Endpoints: * Part A: Describe real-world treatment patterns for hyperlipidemia management * Part B: Percentage change in LDL-C from baseline to Week 12 Oversight: * Independent Data Monitoring Committee (DMC) * Trial Management Committee * Ethics Committee of Sun Yat-sen University Cancer Center (Approval No. B2026-159-01) Participating Centers: 8 sites across China

The goal of this clinical trial is to learn if a nudging intervention (using text message reminders, a medication calendar, and action planning) can help people with atrial fibrillation take their blood-thinning medication (anticoagulants) as prescribed. The main questions it aims to answer are: Does the nudging intervention improve medication adherence compared to usual care? How does the intervention affect patients' beliefs about their medication and the automaticity of pill-taking? Is the intervention cost-effective? Researchers will compare participants who receive the nudging intervention with those who receive usual care. Participants will: Watch a short educational video about atrial fibrillation and stroke prevention Make a personal plan to take their medication at the same time each day (for example, after breakfast) Receive text message reminders 1 to 3 times per week, with fewer messages over time Get a medication calendar to track daily doses Answer a few questionnaires at the start, at 8 weeks, and at 12 weeks

The main objective of this prospective study is to evaluate the effectiveness and safety of a novel neoadjuvant therapy for patients with locally advanced sinonasal carcinoma (SNC). The treatment consists of the standard TP chemotherapy regimen (docetaxel and cisplatin) combined with dual immunotherapy (sintilimab and ipilimumab N01) administered before surgery. Researchers aim to determine the major pathological response (MPR) rate and long-term survival outcomes, while also exploring if this combination treatment approach can help better preserve critical facial and organ functions for SNC patients.

This is a non-inferiority, multicenter, randomized phase 3 trial aimed at investigating the impact of individualized primary clinical target volume based on margin expansion on patients' prognosis and complications compared with the consensus primary clinical target volume based on margin expansion and stepwise extension pattern for patients with newly diagnosed non-metastatic nasopharyngeal carcinoma.

The goal of this clinical trial is to evaluate whether the addition of pelvic radiotherapy to androgen deprivation therapy (ADT) can delay disease progression and improve survival outcomes in patients with pathologically confirmed regional lymph node-positive (pN1) prostate cancer after radical prostatectomy. The main questions it aims to answer are: * Does ADT combined with pelvic radiotherapy improve biochemical recurrence-free survival (bRFS) compared with ADT alone in pN1 patients? * Does the addition of pelvic radiotherapy improve clinical progression-free survival, metastasis-free survival, overall survival, and prostate cancer-specific survival without unacceptable toxicity? Researchers will compare ADT plus pelvic radiotherapy with ADT alone to see if combined treatment improves disease control and long-term clinical outcomes. Participants with positive lymph nodes after prostatectomy will be randomly assigned in a 2:1 ratio to receive ADT plus pelvic radiotherapy, or ADT alone. ADT will be administered for 2 years. Patients with radiologically detectable pelvic recurrence or distant metastases after radical prostatectomy will be excluded. Safety, adverse events, and health-related quality of life will be assessed during follow-up.

This study aims to determine whether postoperative hypoxia (arterial partial pressure of oxygen (PaO₂)\<80 mmHg) is an independent risk factor for anastomotic leakage after esophagectomy. The investigators conducted a retrospective analysis of cases from their center over the past five years, stratifying patients into Low Pa0₂ Group and Normal Pa0₂ Group based on postoperative oxygen levels and comparing the incidence of anastomotic leakage between the groups. The goal is to establish whether hypoxia is a causative risk factor and whether correcting it can reduce the risk of anastomotic leakage.

This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.

The primary objective of this trial is to evaluate the safety and tolerability of the tumor neoantigen vaccine (SarcVac) in combination with a PD-1 antibody, with or without tumor-specific lymphocytes, in patients with advanced bone and soft tissue sarcoma who have failed first-line treatment. The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, in these patients and to evaluate whether the vaccine's efficacy demonstrates dose dependency.

This study aims to utilize a randomized controlled trial in asymptomatic hyperuricemic individuals to clarify the effects of four probiotic strains including Lactobacillus acidophilus on serum uric acid levels, pathways of uric acid synthesis, degradation and excretion, hyperuricemia-induced oxidative stress and chronic inflammatory responses, uric acid-related metabolites, gut microbiota composition and diversity.

TME remains standard treatment for rectal cancer. Both Robotic TME and taTME are innovative surgical techniques with potential advantages in low rectal cancer. To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population. Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.

The purpose is to explore the efficacy and safety of the combination of albumin-bound paclitaxel and liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma.

The aim of this study was to investigate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment.

Purpose: To evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP/TC regimen) for patients with locally advanced cervical cancer. Eligibility Criteria: Women aged 18 to 70 years with newly diagnosed, histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO stage IB3 or IIA2, with no evidence of significant lymph node involvement (pelvic and paraaortic lymph nodes \<1.5 cm in short diameter), and who have not received any prior anticancer therapy. Study Procedures: Participants will receive up to 4 cycles of QL1706 plus TP/TC chemotherapy (once every 3 weeks) prior to surgery. After 2 cycles, clinical assessment will be performed to evaluate tumor response. If tumor shrinkage is observed, treatment may continue for 2 additional cycles, followed by imaging evaluation. Depending on the response, participants with complete or partial response may undergo less extensive surgery (cervical conization plus sentinel lymph node biopsy) rather than standard radical hysterectomy. After surgery, participants who achieve a major pathological response will receive QL1706 maintenance therapy as a single agent for up to 8 additional cycles (once every 3 weeks). For participants with insufficient tumor response, standard radical hysterectomy will be performed. Postoperative adjuvant therapy (radiation or chemotherapy) will follow standard clinical guidelines. Primary and Secondary Objectives: The primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life. Study Duration: Total participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).

Primary Objective: To evaluate the effectiveness of Thymosin Alpha-1 combined with PD-1 monoclonal antibody in elderly patients with advanced melanoma . Secondary Objective: To evaluate the safety and tolerability of adenpeptide-α1 combined with PD-1 antibody in elderly patients with advanced melanoma . Study Design：Open-label, single-arm, non-controlled clinical trial. Primary Inclusion Criteria: 1. Age ≥60 years old; 2. Pathologically confirmed as inoperable or metastatic melanoma; 3. one or more lesions evaluable by RECIST1.1 standards. 4. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2; Main exclusion criteria: 1. Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months; 2. Received thymosin class drug treatment within 3 months before signing the informed consent. 3. Symptomatic, untreated central nervous system metastases. Treatment： Thymosin Alpha 1 1.6mg, sc，QD，d1-7;1.6mg, sc， three times per week, d8-21. Each 21 days is considered one cycle, for a total of 12 weeks. Anti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip，Q3W，4 cycles. Primary study endpoints: Objective Response Rate (ORR: CR+PR) Secondary study endpoints: Progression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS) Adverse Events (AEs)

This is a multicenter, open-label, randomized controlled phase II/III study evaluating the efficacy and safety of QL1706 in combination with anlotinib as later-line treatment in patients with advanced lung cancer.

This clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.

The goal of this clinical trial is to learn the efficacy of combination therapy with tirzepatide, empagliflozin and pioglitazone versus standard therapy in newly diagnosed type 2 diabetes. The main objectives to achieve are: 1. To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM. 2. To compare the effects on β-cell function and glycemic control of the triple combination therapy against standard therapy in patients newly diagnosed with T2DM Researchers will compare drug new triple combination therapy with tirzepatide, empagliflozin, and pioglitazone to standard therapy (metformin based treatment) to see if new triple combination therapy works better in achieving type 2 diabetes remission. Participants will: 1. Take new triple combination therapy or a standard therapy every day for 6 months 2. Visit the clinic once every 0.5-1 month for checkups and tests 3. Keep a diary of their fingertip blood glucose and adverse events

The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

This is a phase II trial in patients with locally advanced or metastatic non-small cell lung cancer harboring HER2 gene abnormalities （amplification or overexpression）with a performance status of 0 to1 who are planned to receive first-line treatment or who have falied the first-line treatment

This is a prospective, multicenter, randomized controlled, phase II study. It is expected to enroll 229 patients and aims to evaluate the efficacy and safety of FOLFOX8 versus mFOLFOX6 combined with bevacizumab or cetuximab as first-line treatment for unresectable metastatic colorectal cancer. The primary objective is to assess progression-free survival (PFS) of the patients. Secondary objectives include assessment of objective response rate (ORR), overall survival (OS), safety, and other outcomes.

To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer

This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of pirtobrutinib as maintenance therapy in patients with relapsed or refractory B-cell lymphoma after commercial anti-CD19 CAR-T cell therapy.

To evaluate the safety of adebrelimab combined with SHR2554 in the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) and NK/T-cell lymphoma (NKTCL), to determine the recommended Phase 2 dose (RP2D) of the combination regimen, and to assess preliminary efficacy.