Guang Zhou Shi

Researchers are studying high-risk head and neck squamous cell carcinoma to see if using two courses of cisplatin chemotherapy alongside radiation after surgery can provide similar benefits compared to the standard three courses. This Phase 3 trial focuses on the 3-year failure-free survival rate to determine if the shorter treatment is not significantly less effective. The study also examines the effectiveness and side effects of two courses of cisplatin chemotherapy given during radiation therapy after surgery. Participants receive cisplatin chemotherapy at a dose of 100 mg/m2 by intravenous injection every three weeks, specifically on days 1 and 22, combined with intensity-modulated radiation therapy. This is compared to the standard approach of three courses given on days 1, 22, and 43. The trial is randomized and multicenter, aiming to evaluate whether fewer chemotherapy courses can maintain treatment success while potentially reducing toxicity. During the study, participants will be monitored for treatment outcomes including failure-free survival over three years. Researchers will assess treatment efficacy and toxicity, with regular medical evaluations to monitor liver, kidney, and bone marrow function. Patients must provide informed consent and meet strict eligibility requirements, including good physical function and no distant cancer spread. The study helps understand if a shorter chemotherapy regimen is a viable option for this patient group.

Researchers are evaluating remibrutinib (LOU064) in adolescents aged 12 to under 18 years who have chronic spontaneous urticaria (CSU) that is not well controlled by H1-antihistamines. This Phase 3 trial aims to assess the effectiveness, how the drug is processed in the body, and safety of remibrutinib compared to a placebo. The study also intends to gather long-term data on how well remibrutinib works and its safety over several years after treatment ends. The trial includes three periods. First, the core period is a 24-week double-blind phase where about two-thirds of participants receive remibrutinib and one-third receive placebo, with about 10 site visits over approximately 32 weeks. Next is an optional open-label extension lasting from one to three years, where participants who completed the core period may receive remibrutinib or enter an observational treatment-free phase depending on their symptoms. Participants may cycle through treatment and observational periods up to six times. Finally, an optional long-term treatment-free follow-up can last up to three years with one site visit and up to four phone calls. During the study, participants undergo assessments including changes in urticaria activity scores (UAS7), itching severity (ISS7), and hive severity (HSS7) measured from baseline to 12 weeks. Regular visits monitor safety, symptoms, and drug effects. The study tracks these measures to understand remibrutinib's impact on CSU symptoms and overall safety profile during and after treatment, with total participation potentially lasting several years.

Researchers are evaluating the safety and effectiveness of different courses of pembrolizumab combined with carboplatin and albumin-bound paclitaxel as neoadjuvant therapy for patients with resectable head and neck squamous cell carcinoma (stages T3 or T4, N0). This phase II, prospective, two-arm study aims to compare four courses versus two courses of this combination treatment, focusing on pathological complete response and treatment safety. Additional goals include comparing survival rates, pathological response rates, radiological responses, and operation delay rates between the two groups, while also exploring factors influencing prognosis and treatment outcomes. Participants are randomly assigned to receive either four or two courses of pembrolizumab (200 mg IV on day 1 of a 21-day cycle), carboplatin (300 mg/m2 IV on day 1), and albumin-bound paclitaxel (260 mg/m2 IV on day 1). The study observes tumor and adjacent tissue changes through imaging and pathology before and after treatment and collects various clinical data such as pathological grade, stage, prognosis, and serology. Treatment adherence and safety are closely monitored throughout the study period. During the study, participants undergo evaluations including imaging, pathological examinations, laboratory tests, and collection of clinical and serological information. Researchers track adverse events within 90 days after surgery, assess pathological complete response at 6 weeks, and analyze other outcomes like event-free survival and overall survival. The study also collects hematological, pathological, and fecal samples to explore correlations with treatment effects. Total participation duration and follow-up include safety monitoring and evaluation of long-term responses.

Researchers are evaluating the effects of reduced-dose radiotherapy (40.2Gy) compared to conventional-dose radiotherapy (49.2Gy) on low-risk target volumes in patients with chemosensitive intermediate-stage nasopharyngeal carcinoma. This phase 3 trial includes patients who have responded well to induction chemotherapy and whose plasma EBV-DNA levels have dropped to zero or below detection limits. The goal is to see if lowering the radiation dose can maintain treatment effectiveness while reducing side effects and improving quality of life. Participants will be randomly assigned to receive either reduced-dose or conventional-dose radiotherapy targeting the CTV2 area, while both groups receive the full course of PD-1 monoclonal antibody immunotherapy. The immunotherapy consists of 12 courses given every three weeks, starting with induction chemotherapy and continuing through radiotherapy and post-radiotherapy maintenance. Induction chemotherapy includes three cycles of gemcitabine and cisplatin or alternative drugs, administered intravenously. Throughout the study, patients will be closely monitored for progression-free survival and the occurrence of significant adverse events over three years. Researchers will assess survival outcomes, side effects, and quality of life differences between the two groups. Regular evaluations include imaging, laboratory tests, and clinical assessments to ensure patient safety and treatment effectiveness during the entire follow-up period.

Researchers are evaluating the effectiveness and safety of 68Ga-PSMA-11 PET/CT or PET/MRI scans in detecting biochemical recurrence of prostate cancer in Chinese male patients. This prospective, open-label, single-arm, multicenter phase 3 study focuses on patients who have experienced a rise in PSA levels after radical prostatectomy or radical radiotherapy. The study aims to assess how accurately 68Ga-PSMA-11, a new tracer called Illuccix®, identifies recurrent prostate cancer compared to histopathology, PSA monitoring, and conventional imaging over a 12-month period. Participants receive a single intravenous dose of 68Ga-PSMA-11 ranging from 111 to 259 MBq administered over 3 to 5 minutes. PET/CT or PET/MRI scans are then performed between 50 and 100 minutes after the injection. These imaging procedures help detect tumor recurrence at the patient level. The study does not mention additional treatment or comparator groups. It is conducted across multiple centers in China, focusing on this specific patient population. During the study, participants undergo scheduled PET scans and clinical monitoring including PSA measurements and follow-up imaging to confirm the presence of recurrent tumors. The main outcome measured is the positive predictive value of the imaging tests for detecting prostate cancer recurrence confirmed by biopsy, clinical markers, or imaging over one year. Safety and tolerability of the tracer and imaging procedures are also observed to ensure participant well-being throughout the study.

Researchers are evaluating the safety and effectiveness of combining the drug 9MW2821 with Toripalimab in patients with urothelial cancer who are undergoing surgery. This phase II clinical trial is open-label and conducted at multiple centers. It focuses on patients with confirmed non-metastatic urothelial cancer, including muscle-invasive bladder cancer and high-risk upper tract urothelial carcinoma. Participants receive intravenous infusions of 9MW2821 at a dose of 1.25 mg/kg and Toripalimab at 240 mg. The study follows a single treatment arm design without a comparison group. The combined treatment is administered around the time of surgery (perioperative period) to assess its impact on the cancer. During the study, participants will be monitored for up to 24 months to measure outcomes such as pathological complete response (pCR) in certain groups and clinical complete response (cCR) in others. Researchers will evaluate safety and efficacy through laboratory tests, imaging, and other assessments. Participants must meet specific health and eligibility criteria and agree to follow study procedures throughout the trial duration.

Researchers are studying a new treatment combination for adults with advanced breast cancer that is estrogen receptor positive, HER2 negative, and GRPR positive. The trial aims to find the recommended dose of the drug [177Lu]Lu-NeoB when given with ribociclib and fulvestrant to participants who have experienced early relapse after endocrine therapy or whose disease has progressed after endocrine therapy combined with a CDK4/6 inhibitor. This Phase 1 study includes a dose escalation part and a backfill part to assess safety, tolerability, and preliminary effectiveness. Participants will receive [177Lu]Lu-NeoB once every 28-day cycle for six cycles, ribociclib daily on days 1 to 21 of each cycle, and fulvestrant on specific days beginning at cycle 1. Pre- or perimenopausal women and men will also receive goserelin. The trial includes imaging with the radioactive agent [68Ga]Ga-NeoB at screening, possibly at cycle 2 day 15, and again 4 to 8 weeks after the last dose of [177Lu]Lu-NeoB to help locate cancer lesions. During the study, participants visit the clinic regularly for treatment, safety checks, and tumor assessments. Safety follow-up continues for 8 weeks after treatment ends, with extended monitoring every 12 to 24 weeks for up to 5 years to track side effects, adverse events, and treatment interruptions. Researchers will closely observe any dose-limiting toxicities and evaluate overall safety and effectiveness throughout the study period.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are studying patients diagnosed with locally advanced oral squamous cell carcinoma or locally advanced oropharyngeal squamous cell carcinoma. The study aims to observe tumor regression patterns and evaluate the safety and effectiveness of neoadjuvant immunochemotherapy given before surgery. It is a bidirectional, single-arm, single-center case series that includes both retrospective and prospective patient data collected starting from 2023. Patients receive two cycles of neoadjuvant immunochemotherapy consisting of tislelizumab combined with paclitaxel and either cisplatin or carboplatin. This treatment is administered at the study institution. The investigation focuses on how tumors respond to this combination before surgery and tracks outcomes such as progression-free survival and overall survival over several years. Participants will undergo regular assessments to monitor treatment safety and tumor response. Researchers will evaluate objective response rates after 8 weeks and follow patients to measure 2-year progression-free survival and 5-year overall survival. The study also examines tumor regression patterns and collects clinical data to understand the treatment effects. Patient health, vital organ function, and ability to tolerate treatment and surgery are closely monitored throughout the study.

Researchers are evaluating TQB2934, a special antibody designed to treat multiple myeloma, a type of malignant plasma cell tumor. TQB2934 is a double-specific antibody that binds to both the CD3 receptor on T cells and the BCMA antigen on cancerous plasma cells. This binding helps recruit and activate T cells to attack and kill the cancer cells. The study is a Phase 1 clinical trial focusing on the safety and pharmacokinetics of this treatment in adults with multiple myeloma. The treatment involves subcutaneous injections of TQB2934. The antibody works by activating T cells to release substances that kill BCMA-positive target cells. The study monitors participants over time to assess how the drug is processed in the body, including measures like peak drug concentration and elimination half-life within 120 hours after administration. The trial also tracks adverse events for up to 24 months. Participants will undergo various laboratory tests and assessments to meet study requirements and monitor their health throughout the trial. Researchers will evaluate pharmacokinetics, including peak time, drug concentration, and clearance, as well as safety by recording any adverse events. The study includes careful monitoring of participants' condition and treatment responses, with follow-up lasting up to two years to ensure comprehensive safety data collection.