Eribulin mesylate in combination with ivonescimab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer(EMIT): study protocol for a single-arm, multicenter clinical trial

BackgroundAdvanced triple-negative breast cancer (TNBC) has an extremely poor prognosis, and current therapies offer limited benefits for patients with low programmed cell death ligand 1(PD-L1) expression. This study innovatively proposes a “novel chem…

Efficacy and safety of induction benmelstobart plus anlotinib and chemotherapy followed by concurrent chemoradiotherapy and benmelstobart consolidation versus concurrent chemoradiotherapy followed by benmelstobart consolidation in patients with unresectable stage III NSCLC: a randomized, controlled, multicenter phase II trial protocol (BEAM-LUNG)

BackgroundThe PACIFIC and GEMSTONE-301 trials established consolidation immunotherapy post-chemoradiotherapy for unresectable stage III NSCLC, but 22–30% of patients fail initial chemoradiotherapy, precluding consolidation. PACIFIC-2 and CheckMate 73L …

A phase II clinical trial of neoadjuvant chemotherapy combined with immunotherapy and different radiotherapy fractionation regimens in HR+/HER2- breast cancer

BackgroundThe modest neoadjuvant response in early-stage HR+/HER2- breast cancer necessitates novel treatment intensification strategies. While radiotherapy can enhance systemic efficacy via immune modulation, the optimal fractionation for integration …

Design of the MERCURION-IPF trial – intravenous immunoglobulin for the treatment of acute exacerbations of idiopathic pulmonary fibrosis

IntroductionDespite their profound clinical impact and high mortality, acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) still lack any effective or standardized treatment strategies. This manuscript describes the rationale and design of a …

Exploring the optimal regimen in advanced hepatocellular carcinoma: a protocol of individual patient data network meta-analysis of randomized controlled trials

BackgroundAdvanced hepatocellular carcinoma (HCC) poses a substantial global disease burden. Since the approval of sorafenib in 2007, an increasing number of treatment regimens have demonstrated encouraging survival benefits in first-line treatment of …

Effect of angiotensin II receptor blockers on efficacy and safety of Camrelizumab plus chemotherapy in the first-line therapy for advanced non-small cell lung cancer (ARMOR I): a protocol for a prospective, real-world, multicenter, intervention clinical trial

BackgroundLung cancer, particularly non-small cell lung cancer (NSCLC), remains a leading cause of cancer-related mortality worldwide. While immune checkpoint blockade (ICB), such as PD-1/PD-L1 inhibitors, have revolutionized treatment for advanced NSC…

The efficacy, safety, and pharmacokinetics/pharmacodynamics of telitacicept following efgartigimod in generalized myasthenia gravis: protocol of a randomized controlled trial

IntroductionSeveral biologic agents have emerged as novel therapeutic options for patients with generalized myasthenia gravis (gMG); however, no clinical studies have yet explored the efficacy and safety of sequential biologic therapy in gMG.Methods an…

A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028

BackgroundNeoantigen-based vaccines show promising therapeutic potential in solid tumors such as melanoma, GBM, NSCLC, and CRC. However, clinical responses remain suboptimal in stage IV patients, due to ineffective T-cell function and high tumor burden…

Short-course PD-1 blockade in locally advanced nasopharyngeal carcinoma: a phase II randomized trial protocol (Tori-013)

While immunotherapy has demonstrated encouraging efficacy in locally advanced nasopharyngeal carcinoma (LANPC), the optimal combination modalities and treatment duration remain undetermined. In the present study, we developed a clinical trial protocol …

Fruquintinib and sintilimab plus SOX as perioperative therapy for locally resectable advanced gastric/gastroesophageal junction adenocarcinoma: study protocol for a prospective, single-arm, phase II clinical trial

BackgroundLocally advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma faces high recurrence risks despite radical surgery. Perioperative chemotherapy (e.g., FLOT regimen) improves survival but has limited pathological complete response (p…

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