Antireflux mucosal valvuloplasty versus proton pump inhibitors for the treatment of patients with gastro-oesophageal reflux disease in a tertiary healthcare centre in China: study protocol for a randomised controlled trial

Introduction
Endoscopic antireflux therapy has shown promising potential in the treatment for gastro-oesophageal reflux disease (GERD). However, there is currently no universally accepted standard for endoscopic surgery. Therefore, we introduced antireflux mucosal valvuloplasty (ARMV), an innovative endoscopic treatment for GERD. We have conducted a cohort study to assess the association between ARMV and clinical outcomes, including risks and benefits. The objective of this trail is to compare the efficacy of ARMV with proton pump inhibitors (PPIs) therapy.

Methods and analysis
74 patients with chronic GERD will be randomised (1:1) to undergo either ARMV or continue PPI therapy. The primary endpoint is the GERD health-related quality of life score, measured 6 months postprocedure. Secondary endpoints include the GERD questionnaire score, presence of reflux oesophagitis, appearance of the mucosal flap, DeMeester score, PPI usage and the incidence of adverse events. After 6 months, crossover is allowed for the PPI group. Assessments will occur at baseline and at 3, 6, 12, 24 and 36 months postintervention.

Ethics and dissemination
The study protocol has been approved by the Institutional Review Board of Qilu Hospital, Shandong University. Study results will be disseminated through peer-reviewed journals and presented at scientific conferences.

Trial registration number
ClinicalTrials.gov (NCT 06348420).

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Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastro-oesophageal junction adenocarcinoma: study protocol for a single-arm, phase II clinical trial

Introduction
Neoadjuvant chemotherapy has been demonstrated to be effective and recommended as the standard treatment option in patients with locally advanced gastric or gastro-oesophageal junction (G/GOJ) cancer. In this study, we will explore the efficacy and safety of chemotherapy combined with cadonilimab, a programmed death-1/cytotoxic T lymphocyte-associated antigen-4 bispecific antibody, in neoadjuvant therapy for locally advanced G/GOJ adenocarcinoma.

Methods and analysis
This is a single-centre, single-arm, open-label, phase II trial that will enrol 37 patients in total. Eligible patients will be registered and receive three cycles of oxaliplatin and S-1 (SOX) regimen in combination with cadonilimab. Radical D2 (D2 lymphadenectomy) gastrectomy will be performed within 4 weeks after the last administration of chemotherapy plus cadonilimab. The primary endpoint is the pathological complete response rate. Secondary endpoints are R0 resection rate, major pathological response, 2-year disease-free survival rate, 2-year overall survival rate and safety. The first participant was recruited on 1 September 2023 and the enrolment will be completed in July 2025.

Ethics and dissemination
Written informed consent will be required from and provided by all the patients enrolled. The study protocol (V.3.0, 28 April 2023) has been approved by the independent ethics committee of West China Hospital, Sichuan University (approval number: 2023526) and conducted under the Declaration of Helsinki. The results of the study may provide more evidence for neoadjuvant immunotherapy combined with chemotherapy in locally advanced G/GOJ adenocarcinoma.

Trial registration number
ClinicalTrials.gov, NCT05948449.

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