Lan Zhou Shi

Researchers are evaluating the diagnostic accuracy of 68Ga-PSMA PET scans compared with enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to determine whether the use of 68Ga-PSMA PET can influence treatment decisions for these patients. This is a prospective, multicenter study focusing on patients with stage III or IV renal cell carcinoma as defined by the 2017 AJCC TNM staging system. Participants will undergo 68Ga-PSMA PET / CT imaging within 6 weeks after their renal cell carcinoma diagnosis. This diagnostic test is being studied for its potential impact on clinical decision-making in renal cancer management. The trial aims to assess the additional diagnostic value of 68Ga-PSMA PET compared to standard CT imaging. During the study, patients will be monitored over a 2-year period to evaluate the diagnostic effectiveness of the 68Ga-PSMA PET. Researchers will collect data on imaging results and observe any changes in treatment plans based on PET findings. Safety and kidney function will also be considered, especially since renal impairment or ongoing hemodialysis are exclusion factors. Participants will provide informed consent before joining the study.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.

Researchers are evaluating the effectiveness and safety of TQB2102 injection compared to a combination of docetaxel, trastuzumab, and pertuzumab in treating adults with HER2 positive recurrent or metastatic breast cancer. This Phase III, randomized, open-label, multicenter trial aims to compare these treatments in patients who have not received systemic anti-tumor therapy during their recurrence or metastasis stage, except for limited first-line endocrine therapy. Participants must have HER2 positive invasive breast cancer confirmed by pathology and measurable lesions. Participants are randomly assigned to one of two treatment groups in equal numbers. One group receives TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab as a positive control. The study monitors the patients during treatment and collects data on tumor response and progression. During the study, participants undergo regular assessments including imaging to measure tumor size and progression according to RECIST 1.1 criteria. Researchers track the objective response rate and progression-free survival for up to approximately 30 months. Safety and adverse events are monitored throughout the trial, and participants must have good compliance and major organ function to continue. The study includes long-term follow-up to assess treatment outcomes and tolerability.

Researchers are evaluating the safety and effectiveness of TQB3702 tablets combined with immunochemotherapy in treating B-cell lymphoma. This phase II clinical trial focuses on patients with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B cell lymphoma (DLBCL). Participants must meet diagnostic criteria according to the 2022 World Health Organization standards and have measurable disease. The treatment involves administering TQB3702 tablets, a tyrosine kinase inhibitor, together with a chemotherapy regimen designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, enhance immune function, and inhibit blood vessel formation that supports tumors. The study monitors patients throughout the treatment period to assess the combined therapy's impact on lymphoma. Participants will be closely observed during the study to evaluate their response to treatment, including overall response rate and complete response rate over a period of up to two years. Researchers will perform regular assessments of organ function, tumor measurements, and safety monitoring. Women of childbearing potential and men must agree to use contraception during the study and for six months afterward. The trial includes follow-up to ensure participant safety and treatment effectiveness over time.

Researchers are evaluating the efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are evaluating the efficacy and safety of TQ05105 tablets in patients with moderate to severe chronic graft-versus-host disease (cGVHD) who have already received systemic therapies. This is an open-label, multicenter Phase II clinical trial focusing on patients aged 18 to 70 years old who have undergone allogeneic hematopoietic stem cell transplantation and have stable disease requiring further treatment. The study aims to measure the objective response rate at 24 weeks to assess treatment impact. TQ05105 tablets contain Rovadicitinib, a novel oral drug that inhibits JAK 1/2 and ROCK 1/2 enzymes, targeting both inflammatory and fibrotic components of cGVHD. Participants will receive this drug as part of the trial, and their response to treatment will be carefully monitored during the study period. The trial involves patients who have previously been treated with immunosuppressants and are on a stable dose of glucocorticoids or other therapies. Participants will undergo regular assessments including blood tests to measure neutrophil, platelet, and hemoglobin levels, as well as liver, kidney, and coagulation function tests. Researchers will monitor safety and treatment response throughout the 24-week study period. Patients must agree to use contraceptive measures during and for six months after the trial. The study excludes those with recent malignancies, active acute GVHD, recent infections, recent use of similar inhibitors, or other serious uncontrolled illnesses.

Researchers are evaluating TQB2102, a new antibody-drug conjugate designed to target tumor cells in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study focuses on assessing the safety and effectiveness of TQB2102, which combines a humanized antibody against HER2 with a powerful drug payload to kill cancer cells more specifically and potently than traditional treatments. The study includes patients who have not responded successfully to previous platinum-based chemotherapy. Participants will receive TQB2102 injections, which is a HER2 dual-antibody-drug conjugate. The treatment is given to women with measurable lesions confirmed by RECIST 1.1 criteria, and who have varying levels of HER2 expression in their tumor tissue. Women of childbearing potential must have a negative pregnancy test before starting and agree to use highly effective contraception throughout the study. The treatment period and dosing schedules are designed to monitor the drug's impact carefully. Throughout the study, participants will be closely monitored for overall response rate up to 12 months. Assessments include regular evaluations of tumor response, safety checks, and compliance with treatment. The study excludes patients with certain health conditions, recent surgeries, or other treatments that might interfere. The total duration and detailed follow-up procedures ensure thorough observation of TQB2102's effects and participant safety.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.