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Investigational Use of Real-World Data as a Hybrid Control in Pancreatic Ductal Adenocarcinoma from the Randomized Phase Ib/II MORPHEUS Trial.
Clin Pharmacol Ther
December 2024
Cancer Center Clinica Universidad de Navarra and Program in Solid Tumors (CIMA), Universidad de Navarra, IDISNA, Pamplona, Spain.
Enrolling adequate numbers of patients into the control arm of randomized controlled trials (RCTs) often presents barriers. There is interest in leveraging real-world data (RWD) from electronic health records (EHRs) to construct external control (EC) arms to supplement RCT control arms and form hybrid control (HC) arms. This investigation showed the use of an HC arm in second-line metastatic pancreatic ductal adenocarcinoma (PDAC).
View Article and Find Full Text PDFPhase Ib/II study of imprime PGG and pembrolizumab in patients with previously treated advanced non-small cell lung cancer (NSCLC): BTCRC LUN 15-017.
Transl Lung Cancer Res
November 2024
Division of Hematology-Oncology, Department of Medicine, University of Illinois, Chicago, IL, USA.
Background: Therapeutic strategies to engage anti-tumor innate immunity are still underdeveloped. Imprime PGG (imprime), a pathogen-associated molecular pattern (PAMP), through pattern recognition receptors, successfully illicit a broad-based innate immune response in preclinical models against various cancers. We aimed to study safety and efficacy of imprime in combination with pembrolizumab in advanced stage non-small cell lung cancer (NSCLC).
View Article and Find Full Text PDFSOX combined with tislelizumab and low-dose radiation therapy for the neoadjuvant treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase Ib/II clinical trial.
Front Immunol
November 2024
Gastric Cancer Center, Division of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Article Synopsis
- * It involves a prospective, multicenter, single-arm trial split into two phases: phase Ib will evaluate different radiation doses with 5 patients per group, while phase II aims to enroll 44 patients with a focus on the rate of pathological complete response (pCR) as the primary endpoint.
- * The study will also assess secondary outcomes such as R0 resection rates, event-free and overall survival rates, safety, and potential molecular markers, highlighting its novelty
Spatial interactions of immune cells as potential predictors to efficacy of toripalimab plus chemotherapy in locally advanced or metastatic pancreatic ductal adenocarcinoma: a phase Ib/II trial.
Signal Transduct Target Ther
November 2024
Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Article Synopsis
- Advanced pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, and this study tested whether combining the immunotherapy toripalimab with chemotherapy (gemcitabine and nab-paclitaxel) could improve treatment outcomes for patients with advanced PDAC.
- The results showed median overall survival of 8.9 months and a good safety profile, with no serious side effects reported among the 72 participants.
- Biomarkers like PD-L1 expression and immune cell interactions were explored, revealing that specific immune cell spatial interactions were significant predictors of treatment response, suggesting potential for tailored therapies in this context.
Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study.
Nat Commun
November 2024
Department of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China.
This was a multicenter, single-arm, open-label, phase Ib/II study (NCT04255576), aimed to evaluate the efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone (GCTB). JMT103 (2 mg/kg) was administered subcutaneously every four weeks, with loading doses on days 8 and 15. The primary endpoint was the objective tumor response rate (OTR) based on best response, defined as the proportion of patients who achieved elimination of at least 90% of the giant cells or radiologic complete or partial response per the modified Inverse Choi density/size (mICDS) or modified European Organization for Research and Treatment of Cancer (mEORTC) within 12 weeks.
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