Guang Zhou Shi

Researchers are evaluating whether giving 2 courses of cisplatin chemotherapy along with postoperative radiotherapy is as effective as 3 courses in treating patients with high-risk head and neck squamous cell carcinoma after surgery. This phase 3 randomized trial focuses on patients with advanced stages III and IV of this cancer type who have undergone radical surgery but have high-risk factors such as extracapsular invasion or positive surgical margins. The main goal is to compare the 3-year failure-free survival rates between the two treatment approaches. Participants will be assigned to one of two groups. One group receives intensity-modulated radiotherapy totaling more than 66 Gy, given once daily five days a week, combined with cisplatin chemotherapy at 100 mgm2 through intravenous injection on days 1 and 22 2 courses. The other group receives the same radiotherapy schedule plus 3 courses of cisplatin chemotherapy on days 1, 22, and 43. Both treatments are delivered under medical supervision to assess outcomes and side effects. During the study, participants will undergo regular assessments to evaluate failure-free survival, overall survival, distant metastasis-free survival, locoregional recurrence-free survival, and quality of life over a 3-year period. Safety and treatment tolerability will also be monitored. The trial includes close follow-up visits and evaluations to measure the effects of the different chemotherapy schedules combined with radiotherapy on cancer control and patient well-being.

Researchers are evaluating the safety and effectiveness of different courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel as preoperative neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma stages T3 or T4, N0. This phase II, prospective, randomized study aims to compare four treatment cycles versus two cycles and assess outcomes such as pathological complete response, adverse events, survival rates, and radiological responses. The study also explores various factors that could influence treatment response and prognosis. Participants are randomly assigned to receive either four cycles or two cycles of pembrolizumab 200 mg IV, carboplatin 300 mgm2 IV, and albumin-bound paclitaxel 260 mgm2 IV every 21 days, followed by surgery. Each treatment cycle occurs on day 1, and continuation depends on absence of disease progression or unacceptable toxicity. The study collects clinical, pathological, imaging, and serological data before and after treatment to evaluate the therapies. During the study, participants undergo assessments including imaging, pathology examination of tumor tissues, and laboratory tests. Researchers monitor adverse events for 90 days post-surgery and measure pathological response six weeks after treatment initiation. Longer-term outcomes such as event-free and overall survival are tracked for up to five years. Data on operation delays and radiographic responses are also gathered to assess treatment safety and efficacy throughout the study duration.

Researchers are studying patients with low-risk intermediate-stage nasopharyngeal carcinoma who have responded well to induction chemotherapy and have undetectable levels of plasma EBV-DNA. The trial compares two doses of radiotherapy targeting a specific low-risk area to evaluate their effects on survival, side effects, and quality of life. This phase 3 randomized study aims to find out if lower-dose radiotherapy can maintain treatment success while reducing toxicities related to treatment. Participants receive either reduced-dose radiotherapy 40.2Gy or conventional-dose radiotherapy 49.2Gy to the low-risk target volume called CTV2. Both groups undergo full-course immunotherapy with the PD-1 monoclonal antibody Tislelizumab, administered every three weeks, totaling 12 courses through induction, radiotherapy, and maintenance phases. Induction chemotherapy using a cisplatin-based regimen is given before radiotherapy. Treatment continues until toxicity, progression, withdrawal, or completion of planned courses. During the study, patients will be monitored for progression-free survival and serious adverse events over three years. Secondary measures include metastasis-free survival, relapse-free survival, overall survival, tumor response rates, and quality of life assessments using standard questionnaires over three years. Safety and effectiveness will be evaluated through imaging, laboratory tests, and clinical evaluations. The study enrollment includes adults aged 18 to 75 years, and the follow-up will provide information on long-term outcomes and treatment impact.

Researchers are evaluating the safety and effectiveness of combining the drugs 9MW2821 and Toripalimab in patients with urothelial cancer who are undergoing surgery. This phase II clinical trial is open-label and involves multiple centers. The study focuses on patients with confirmed non-metastatic urothelial cancer, including muscle-invasive bladder cancer MIBC and high-risk upper tract urothelial carcinoma UTUC. Participants receive intravenous infusions of 9MW2821 at a dose of 1.25 mgkg and Toripalimab at 240 mg. The study includes three groups based on cancer type and risk Arm 1 with MIBC, Arm 2 with high-risk UTUC, and Arm 3 with MIBC. The study is not randomized, and all participants receive the experimental treatment combination. During the study, participants will be monitored for up to 24 months to assess outcomes such as pathological complete response pCR, clinical complete response cCR, overall response rate, disease-free survival, progression-free survival, overall survival, and safety events. Researchers will also evaluate immunogenicity and expression of biomarkers Nectin-4 and PD-L1. Regular assessments include tumor tissue testing and organ function monitoring to ensure participant safety and treatment adherence.

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

Researchers are studying patients with locally advanced oral squamous cell carcinoma LA-OSCC or locally advanced oropharyngeal squamous cell carcinoma LA-OPSCC to understand tumor regression patterns and treatment outcomes. This study collects data both retrospectively and prospectively from patients treated with neoadjuvant immunochemotherapy. The focus is on evaluating treatment safety, effectiveness, and survival rates over several years. Participants receive two cycles of neoadjuvant immunochemotherapy using tislelizumab combined with paclitaxel and cisplatin or carboplatin. This single-arm, single-center study tracks treatment outcomes and tumor responses. The study uses a bidirectional design, collecting past and ongoing patient data to analyze results comprehensively. During the study, researchers monitor tumor response at 8 weeks, assessing the objective response rate and tumor regression patterns. They also follow participants for two years to measure progression-free survival and assess 5-year overall survival rates. Participants undergo regular evaluations to track their health, treatment effects, and disease status throughout the study period.

Researchers are evaluating TQB2934, a special antibody designed to target multiple myeloma, a cancer affecting plasma cells. This antibody binds to T cells and cancer cells to activate the immune system to attack the disease. The study is a Phase 1 clinical trial focusing on safety and the bodys handling of the drug in patients with malignant plasma cell tumors. The study involves giving TQB2934 as a subcutaneous injection at doses of 40mg or 60mg. Treatment cycles occur once weekly during the first three cycles, then every two weeks for cycles four to six. If patients achieve a partial remission or better after six cycles, dosing continues every four weeks. Each treatment cycle lasts 28 days. Participants will undergo various assessments including blood tests to measure drug levels and immune response over 120 hours after each dose. Researchers will monitor adverse events for up to 24 months and evaluate treatment responses such as remission rates and survival outcomes. The total study participation includes treatment and long-term safety follow-up lasting up to two years.

Researchers are studying relapsed or refractory multiple myeloma in adults who have already received treatment with lenalidomide and a proteasome inhibitor but whose disease has progressed. The study aims to evaluate the effects of adding SG301 injection to the standard treatment of pomalidomide and dexamethasone. This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial. The study has two stages. Stage 1 is to find the right dose of SG301 combined with pomalidomide and dexamethasone. Stage 2 randomly assigns participants to receive either SG301 injection plus pomalidomide and dexamethasone or a placebo plus the same drugs. SG301 and its placebo are given by intravenous infusion weekly for 8 weeks, then every 2 weeks. Pomalidomide capsules are taken orally once daily on days 1 to 21 of each 28-day cycle. Dexamethasone is taken orally or by infusion on days 1, 8, 15, and 22, with dose adjusted for low body weight. Participants continue treatment until their disease progresses, unacceptable side effects occur, or other stopping criteria are met. Researchers will monitor side effects, drug levels in the body, immune response, and treatment effects including progression-free survival and overall survival for up to about 4 years. The study includes regular assessments every 4 weeks initially, then every 8 weeks, with safety followed for about 30 days after treatment ends.

Gaucher disease type 1 GD1 is caused by mutations in the GBA1 gene, leading to a deficiency in the enzyme glucocerebrosidase GCase. This deficiency results in the buildup of glucosylceramide GlcCer in various organs, including the liver, spleen, kidney, bone, lung, and brain, causing cells to change and leading to tissue and organ problems. Researchers are evaluating LY-M001, a gene therapy using an rAAV8 vector, which aims to deliver the GCase protein to liver cells after a single intravenous infusion to address this enzyme deficiency. This clinical trial includes two phases Phase I is a dose escalation study with three dose groups, starting at a lower dose and increasing to higher doses to assess safety. Participants receive a single intravenous infusion of LY-M001 at one of the specified doses. Phase II is a dose expansion study where the recommended dose from Phase I is given to more participants to further evaluate safety and efficacy. The study has a main period of 52 weeks following infusion and a long-term follow-up phase lasting from 53 weeks up to 5 years. Participants will undergo regular assessments including monitoring for adverse events, liver function tests, blood enzyme activity, blood counts, imaging of liver and spleen volumes, bone mineral density, and bone marrow evaluation. Safety evaluations also include electrocardiograms, vital signs, and laboratory tests. The study aims to track the effects of LY-M001 over time, with extended follow-up to gather long-term data on safety and treatment impact throughout the study duration.

Researchers are evaluating the safety, tolerability, dosimetry, and preliminary efficacy of 177LuLu-XT117 injection in patients with advanced solid tumors that express fibroblast activation protein FAP. This is a Phase 1, single-center, single-arm clinical study focusing on patients who have FAP-positive tumors and have failed or lack standard treatments. Participants will receive doses of 177LuLu-XT117, a radiopharmaceutical therapy combining the beta emitter Lu-177 with XT117. The treatment is administered every 6 weeks. The study monitors radiation dosimetry at specific time points after the first dose and continues evaluations throughout the treatment period. During the study, participants will be regularly assessed for treatment-emergent adverse events for up to 6 months after the last dose. Researchers will also evaluate tumor response and survival outcomes every 6 weeks for up to 2 years, including overall response rate, duration of response, disease control rate, progression-free survival, and overall survival. Radiation exposure to the whole body and organs is measured at multiple intervals after treatment to understand distribution and safety.