Qianxinan Buyei And Miao Autonomous Prefecture

Researchers are studying 89Zr-TLX250, a diagnostic imaging agent, to detect clear cell renal cell carcinoma ccRCC in Chinese patients with indeterminate renal masses. This Phase 3, open-label, single-arm study aims to confirm the safety, tolerability, sensitivity, and specificity of 89Zr-TLX250 PETCT imaging. The study supports prior ZIRCON trial data and involves adult patients scheduled for partial or total nephrectomy as part of their standard care. Participants will receive a single intravenous dose of 37 MBq of 89Zr-TLX250 containing 10 mg of girentuximab. Imaging of the abdomen using PETCT will be performed 5 days post-administration, with possible whole-body imaging if widespread disease is suspected. Nephrectomy will occur any time after imaging but within 90 days. Histological analysis of tumor samples will confirm diagnosis. The study includes approximately seven visits over 4 to 6 months. Assessments include baseline exams, PETCT imaging, surgery, and follow-up visits. Imaging and histological data will be centrally analyzed to evaluate diagnostic accuracy. Safety and tolerability will be monitored throughout. The study is expected to last about 12 months with 4 months of follow-up per participant.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immune response, and early clinical effects of BNT3212, both alone and combined with pumitamig, in adults with advanced solid tumors who have exhausted other treatment options. This first-in-human, open-label study includes dose escalation and expansion phases to find the best dose and assess how the treatments work across different tumor types. The study is divided into four parts Part A and Part B focus on BNT3212 as a single therapy, with dose escalation followed by dose expansion in specific tumor types. Parts C and D evaluate the combination of BNT3212 with a fixed dose of pumitamig, again starting with dose escalation and then expansion cohorts. Treatments are given by intravenous infusion, and doses are adjusted to find the maximum tolerated dose and recommended dose for further study. Participants will undergo regular monitoring including safety assessments, blood tests to study drug levels and immune reactions, and imaging to measure tumor response. Researchers will track side effects, treatment interruptions, and response rates over approximately 31 months. The study also measures progression-free and overall survival. Continuous evaluation of safety and clinical data supports participant well-being throughout the trial.

Researchers are evaluating the effectiveness and safety of two different approaches to bronchoscopic thermal vapor ablation BTVA treatment using the InterVapor System in patients with severe emphysema. The study compares treating at least two subsegments in different lung segments versus treating at least one whole lung segment. This multi-center randomized controlled trial aims to provide precise treatment options for patients with severe emphysema while continuing optimal medical therapy. Participants are randomly assigned to one of two groups the experimental group receives BTVA treatment targeting at least two subsegments of different lung segments in a single procedure, while the control group receives treatment targeting at least one whole segment per procedure. Each patient undergoes a sequential treatment with a minimum of 6 weeks and up to 6 months between procedures, with a maximum treatment volume defined per procedure and cumulatively across two treatments. Alongside BTVA, all participants continue receiving medical therapy following GOLD guidelines throughout the study. During the study, patients will have follow-up visits at 1, 3, 6, and 12 months after the second procedure. These visits include tests to assess lung function, high-resolution CT scans, a 6-minute walk test, and questionnaires measuring quality of life and respiratory symptoms. The main outcome being evaluated is lung function improvement measured by FEV1 six months after the second procedure. Secondary outcomes include lung volume changes, other lung function measures, exercise capacity, symptom assessments, responder rates, and recording of any adverse events during and up to one year after treatment.

Researchers are conducting a multicenter, non-interventional, descriptive study to collect and analyze solid tumor samples from patients with non-small cell lung cancer NSCLC, biliary tract cancer BTC, gynecological cancers GYN, and urothelial carcinoma UC. The study aims to assess the agreement between different HER2 immunohistochemistry IHC assays and the interpretation consistency among pathologists. This study involves about 2100 patients diagnosed between January 2023 and September 2025 from 12 sites. The study has two phases enrollment and assessment. During enrollment, approximately 2100 patients are retrospectively collected and tested for HER2 status using the Roche 4B5 assay at local labs. A committee reviews and aligns these results. In the assessment phase, 320 patients are selected based on HER2 expression levels to evaluate assay performance and interpretation concordance. Tissue samples are sectioned into at least 15 slides for various assays, including Roche 4B5 and HercepTest, with results reviewed by pathologists. Digitalized slides are interpreted by 36 trained pathologists to evaluate inter-observer agreement. Participants archived tumor tissues are analyzed with multiple assays, and interpretation results are compared to assess agreement. The study measures include positive and negative percent agreement of HER2 IHC assays and inter-observer concordance across different HER2 expression levels. The assessment phase and interpretation evaluations last up to approximately six months. This study does not involve treatment but focuses on comparing testing methods and interpretation consistency for HER2 status in these cancers.

Researchers are conducting a Phase IaIb clinical trial to study GH2616 Tablet in adults with advanced solid tumors. The study aims to evaluate the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and early anti-tumor activity of GH2616. The trial includes patients with tumors such as ovarian, uterine, lung, breast, bladder, and colorectal cancers, especially those with TP53 mutation and whole genome duplication WGD. The study is sponsored by Suzhou Genhouse Bio Co., Ltd.

Researchers are evaluating treatments for women with hormone receptor-positive, HER2-negative advanced breast cancer that has returned or progressed after endocrine therapy. This phase II clinical trial studies the effects of entinostat combined with fulvestrant, with or without the addition of anlotinib, in patients who have previously been treated with CDK46 inhibitors. The study aims to understand how these treatments affect tumor response and disease progression. Participants receive entinostat tablets once a week and fulvestrant injections on specific days within a 28-day cycle. One group receives just entinostat and fulvestrant, while another group receives those plus anlotinib capsules taken daily for two weeks followed by a one-week break, forming a 3-week treatment cycle. Treatment continues until disease progression, intolerable side effects, withdrawal, or other protocol-defined conditions occur. Throughout the study, tumor response is evaluated every 8 weeks using RECIST criteria. Safety is continuously monitored during treatment, with follow-up visits shortly after treatment ends. The study concludes when disease progression occurs or when treatment stops for any reason. Participants are assessed up to two years for response rate, progression-free survival, clinical benefit, and duration of response.

Researchers are studying whether fecal microbiota transplantation FMT can help treat gastrointestinal symptoms caused by chemotherapy or targeted therapy in patients with gastrointestinal cancers. This Phase 1 trial aims to evaluate the effect of FMT on the gastrointestinal tract in these patients, focusing on those with advanced gastrointestinal tumors. The goal is to understand how FMT might reduce side effects linked to cancer treatment. Participants are randomly assigned to one of two groups. The control group continues their usual chemotherapy or targeted therapy cycles every three weeks for five cycles, with treatment effectiveness assessed after every two cycles. The experimental group receives FMT starting from the fourth treatment cycle, with capsules containing donor gut bacteria given orally within three days before chemotherapy during the fourth, sixth, and eighth cycles. Each FMT dose includes about 40 grams of bacteria encapsulated into 120 capsules, taken over a short period during each treatment cycle. Throughout the study, patients undergo regular assessments to track gastrointestinal symptoms and gut microbiota changes. Researchers monitor the incidence and improvement of gastrointestinal side effects at 4 and 8 weeks after FMT. They also analyze gut microbiota diversity and its correlation with symptom improvement. Participants are followed during treatment cycles and for a post-treatment period to evaluate these outcomes, with safety and organ function closely observed.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of JMT203 in patients with cancer cachexia, a condition characterized by severe weight loss in people with cancer. This study includes two parts Phase Ia, focusing on dose escalation and expansion to find safe and effective doses, and Phase II, a randomized, double-blind, placebo-controlled trial involving patients with colorectal cancer cachexia, pancreatic cancer cachexia, or cachexia from other solid tumors. The study aims to determine the recommended dose for future studies and assess preliminary treatment effects over 12 weeks. During Phase Ia, JMT203 will be tested in increasing doses using an accelerated titration design with a 33 dose escalation scheme. Dose expansion will select 1 to 3 potentially effective doses based on safety and pharmacokinetic data. In Phase II, participants will be randomly assigned to receive either JMT203 at 50 mg or 150 mg, or a placebo, administered as subcutaneous injections every three weeks for 12 weeks. An open-label extension phase may continue treatment at 150 mg or the recommended Phase 3 dose for up to 51 weeks. Participants will undergo regular assessments including monitoring adverse events, dose-limiting toxicities, and changes in body weight and muscle mass. Imaging by computed tomography and questionnaires about anorexia severity will be used to evaluate effects. Pharmacokinetic measurements and antibody responses will be tracked up to 90 days after dosing. The study also monitors survival and progression-free survival up to three years. Participants can expect visits for treatment administration, safety checks, and evaluation of their cancer cachexia symptoms throughout the study period.

Researchers are evaluating MRG007 ARR-217 in an open-label, multi-center phase I trial involving patients with unresectable locally advanced or metastatic solid tumors. The study aims to assess the safety, tolerability, efficacy, and pharmacokinetics of MRG007 in this patient population, including those with colorectal, gastric, or pancreatic cancers who have failed or are intolerant to standard therapies. This research is sponsored by ArriVent BioPharma, Inc. and involves dose escalation, confirmation, and expansion phases. Participants receive MRG007 alone or in combination with Bevacizumab according to the study protocol. The trial uses a sequential study model without randomization or masking. Treatment administration follows specific dosing schedules outlined in the protocol, with evaluations of dose-limiting toxicities and adverse events conducted from baseline through 30 days post-treatment. Objective response rates and other efficacy measures are monitored up to 24 months after starting treatment. Throughout the study, participants undergo evaluations including tumor assessments by RECIST criteria, performance status scoring, and laboratory tests to monitor organ and coagulation functions. Safety is closely tracked via serious and treatment-related adverse events. Pharmacokinetic parameters such as Tmax, Cmax, and antibody responses are also measured. Participants may be followed for up to two years to assess treatment response, disease control, progression-free survival, and overall survival.

Researchers are investigating the effects of switching between two targeted treatment strategies, HP plus chemotherapy and HPy plus chemotherapy, in female patients with HER-2 positive advanced or metastatic breast cancer. This observational study includes approximately 600 patients from about 20 research centers nationwide. Separate analyses will be conducted for patients with de novo stage IV disease, recurrent metastatic breast cancer who have not received trastuzumab, and those with brain metastases, but these groups will not be part of the overall analysis. Participants will be naturally assigned in equal numbers to either switch from HP plus chemotherapy to HPy plus chemotherapy or vice versa. If the first-line treatment fails, patients will switch to the alternative regimen during second-line treatment. Treatment continues until disease progression, intolerable side effects, or other reasons for stopping. Chemotherapy cycles are recorded, and if patients cannot tolerate taxanes, alternative drugs like vinorelbine, capecitabine, or eribulin may be used. After chemotherapy or stopping treatment, maintenance therapy may be given based on clinical need. During the study, patients will be monitored every two cycles for disease status, lab tests, drug use, medications, and side effects. After treatment ends, survival follow-up will occur every three months for up to three years to track patient survival. The main outcome measured is progression-free survival assessed by investigators over 60 months, with overall survival also tracked during this time.