Gastroesophageal Junction Adenocarcinoma

P=N/A, N=110, Recruiting, Peking University | Active, not recruiting --> Recruiting

P1/2, N=36, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Suspended --> Active, not recruiting

P=N/A, N=50, Not yet recruiting, Beijing GoBroad Hospital

P2, N=99, Recruiting, Mayo Clinic | Trial completion date: May 2031 --> May 2027 | Trial primary completion date: May 2031 --> May 2027

PD-L1 CPS is shaped by clinicopathological context and biopsy site. The persistently lower CPS ≥ 5 prevalence at SBH despite validated testing highlights assay variability and reinforces the urgent need for assay standardisation. Preferential use of primary tumor tissue may help reduce metastasis-specific bias.

It is currently a clinically relevant predictor for adenocarcinomas of the stomach and the gastroesophageal junction, although its use will likely extend also to other diagnoses. The aim of this report is to provide an overview of selected aspects of CLDN18.2 expression testing, including the choice of appropriate tissue, the issue of tumor heterogeneity, antibodies suitable for testing and their evaluation, where such testing can be performed, and the prospects for the future.

A key feature is the systematic integration of GA tools (Geriatric-8, Cancer and Aging Research Group toxicity score) and PMI analysis to explore efficacy and tolerability predictors. EN-COURAGE represents the first prospective study designed to elucidate real-world T-DXd outcomes in elderly patients with HER2-positive GC.

Gastric or gastroesophageal junction (GEJ) cancers are usually diagnosed at advanced stages with poor prognoses and 5-year survival rates. DESTINY-Gastric05 (NCT06731478) is a global, multicenter, open-label, randomized, phase III trial to evaluate the efficacy and safety of first-line T-DXd 5.4 mg/kg plus 5-fluorouracil or capecitabine and pembrolizumab versus platinum-based chemotherapy with trastuzumab and pembrolizumab in patients with unresectable, locally advanced or metastatic, centrally confirmed HER2-positive (immunohistochemistry 3+ or immunohistochemistry 2+/in situ hybridization positive) gastric or GEJ cancer with a PD-L1 CPS ≥1. An exploratory cohort is to evaluate T-DXd plus 5-fluorouracil or capecitabine in patients with PD-L1 CPS <1.

Anti-CLDN18.2 therapy, primarily consisting of first-line zolbetuximab combined with chemotherapy, significantly improved progression-free survival (PFS) (hazard ratios [HR] 0.564; 95% confidence interval [CI]: 0.417-0.711) and overall survival (OS) (HR 0.716; 95% CI: 0.631-0.802), along with enhanced 1- and 2-year survival rates...Standardized definitions for CLDN18.2 positivity and high expression are urgently needed. www.crd.york.ac.uk/prospero identifier is CRD420251123719.

P1, N=213, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting

P1/2, N=2, Terminated, Aurigene Discovery Technologies Limited | N=18 --> 2 | Trial completion date: Nov 2028 --> Dec 2025 | Recruiting --> Terminated | Trial primary completion date: Nov 2027 --> Dec 2025; Patient recruitment problems.