Lan Zhou Shi

Researchers are evaluating the diagnostic effectiveness of 68Ga-PSMA PET scans compared to enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to see if 68Ga-PSMA PET can influence treatment decisions for these patients. This prospective, multicenter trial is sponsored by Xijing Hospital and focuses on improving diagnosis and management for renal cancer with metastases. Participants in the study will receive both a 68Ga-PSMA PET scan and an enhanced CT scan simultaneously to compare their abilities to detect cancer spread. This diagnostic approach helps assess the additional value that 68Ga-PSMA PET may provide over standard CT imaging. The study does not involve any masking or placebo groups and includes only patients who meet specific clinical and imaging criteria. During the study, patients will undergo imaging within six weeks after diagnosis, and researchers will track how the 68Ga-PSMA PET results affect treatment choices. The primary measurement is the additional diagnostic value of the PSMA PET compared to CT over two years. Secondary outcomes include how often the PET scan changes treatment decisions. The study monitors patient safety and adherence, with a planned follow-up period to evaluate outcomes until December 2027.

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating the effectiveness and safety of a new drug called TQB2102 for Injection compared to a combination treatment of docetaxel, trastuzumab, and pertuzumab in adults with HER2 positive recurrent or metastatic breast cancer. This Phase III trial involves multiple centers and randomizes participants into two groups to compare these treatments. The study aims to better understand how well TQB2102 works and its safety profile in this patient population. Participants receive treatments through intravenous infusions every 21 days. One group is treated with TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab following specific dosing schedules. Docetaxel is given once every three weeks for six cycles, trastuzumab starts with a loading dose followed by maintenance doses every three weeks, and pertuzumab is administered with an initial loading dose followed by maintenance doses every three weeks with observation after infusions. The study compares these two treatment approaches over the course of the trial. During the study, participants will undergo regular evaluations including imaging to assess tumor response, blood tests to monitor drug levels and immune responses, and tracking of any side effects or adverse events. The primary outcomes measured are the objective response rate and progression-free survival up to about 30 months. Secondary outcomes include overall survival, duration of remission, and detailed safety assessments up to around 52 months. The study also involves monitoring specific antibodies related to the drug and other laboratory markers to understand treatment effects fully.

Researchers are evaluating the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for treating B-cell lymphoma. This Phase II clinical trial focuses on patients diagnosed with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B-cell lymphoma DLBCL. The study aims to assess how well this combination therapy works and its overall safety. Participants will receive TQB3702 tablets at a dose of 200 mg every 4 weeks as one treatment cycle. Alongside this, they will undergo chemotherapy cycles every 3 or 4 weeks, with a total of 6 to 12 cycles of combination therapy. The chemotherapy regimen is designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, support immune function, and prevent new blood vessel formation that supports tumors. During the trial, participants will be closely monitored for treatment response and safety. Researchers will measure overall and complete response rates up to 2 years, as well as adverse events, progression-free survival, duration of response, and overall survival up to death from any cause. The study includes assessments from baseline through combination therapy completion and follow-up periods lasting up to 2 years. This comprehensive monitoring helps understand both the immediate and longer-term effects of the treatment.

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

This trial is investigating the use of TQ05105 Tablets in adults aged 18 to 70 with moderate to severe chronic graft-versus-host disease cGVHD following allogeneic hematopoietic stem cell transplantation. The study aims to evaluate the efficacy and safety of this oral medication, which targets inflammatory and fibrotic processes involved in cGVHD. The trial is open-label and multicenter, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and conducted as a Phase II clinical study. Participants receive TQ05105 Tablets twice daily in 28-day treatment cycles. The study measures responses up to 48 weeks, including treatment effectiveness and safety outcomes. The primary outcome is the objective response rate at 24 weeks. Secondary outcomes include duration of response, survival rates, incidence of relapse, and adverse events. The study does not involve placebo or blinding. During their participation, patients will be monitored regularly with assessments to track their response to treatment, side effects, and overall health status. Evaluations include laboratory tests and clinical examinations related to cGVHD severity and treatment impact. The total participation period extends up to 48 weeks or more, with ongoing observation for safety and survival measures. Participants will follow a stable medication regimen and adhere to contraceptive measures if applicable.

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 HER2 positive tumor cells, in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study aims to assess the safety and effectiveness of TQB2102 in this patient population, addressing the need for new treatments after unsuccessful platinum-based chemotherapy. Participants will receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. This investigational drug combines a humanized antibody with a potent drug payload to specifically attack tumor cells. The study includes monitoring for adverse events and anti-drug antibodies during treatment and follow-up. During the trial, participants will undergo regular assessments including tumor measurements to evaluate overall response rate, duration of remission, progression-free survival, overall survival, and disease control rate for up to 12 to 17 months. Safety evaluations will continue until 28 days after the last dose or the start of new cancer therapies. Blood samples for anti-drug antibody testing will be collected at specific treatment cycles and after treatment completion. The total involvement period depends on individual treatment duration and follow-up schedules.

Researchers are evaluating the efficacy and safety of TQH3906, a Tyrosine Kinase 2 TYK2 inhibitor, in treating systemic lupus erythematosus SLE, an autoimmune disease. This randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial aims to assess how well TQH3906 works and its safety profile in adults diagnosed with SLE based on established criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of three groups 16 mg TQH3906 capsule, 24 mg TQH3906 capsule, or placebo. All treatments are taken orally once daily for 48 weeks. The trial compares these doses to placebo to understand TQH3906s impact on disease activity. The study uses a parallel design and includes a quadruple masking method to keep participants and researchers unaware of group assignments. During the study, participants undergo regular assessments including clinical evaluation of disease activity using the Systemic Lupus Erythematosus Responder Index 4 SRI-4, lupus activity indices, and joint assessments up to week 48. Safety is monitored throughout, and background lupus medications must remain stable during the trial. The primary outcome measure is the percentage of participants achieving SRI-4 response by week 32, with additional secondary measures assessing remission, low disease activity, and symptom improvements. Participation lasts up to 48 weeks with scheduled visits and monitoring.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.