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    CANCER:

    Gastroesophageal Cancer

    Related cancers:
    1d
    Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=330, Recruiting, I-Mab Biopharma US Limited | N=168 --> 330 | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date
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    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
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    CLDN18.2 positive
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    Opdivo (nivolumab) • Imfinzi (durvalumab) • givastomig (TJ-CD4B)
    1d
    PET-MRI Esophagus Feasibility Study (clinicaltrials.gov)
    P=N/A, N=15, Recruiting, University Health Network, Toronto | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027
    Trial completion date • Trial primary completion date
    2d
    OLIGOMETS: Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels (clinicaltrials.gov)
    P2, N=54, Recruiting, Yale University | Not yet recruiting --> Recruiting
    Enrollment open • Circulating tumor DNA
    2d
    A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
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    Opdivo (nivolumab) • 5-fluorouracil • Stivarga (regorafenib) • oxaliplatin • leucovorin calcium
    5d
    CA243-0001: A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors (2025-524334-26-01)
    P1, N=15, Not yet recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P1 trial
    7d
    Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial (clinicaltrials.gov)
    P=N/A, N=20, Not yet recruiting, Jonsson Comprehensive Cancer Center
    New trial
    9d
    Immunotherapy and Targeted Therapy for Advanced Gastroesophageal Cancer: ASCO Guideline Update. (PubMed, J Clin Oncol)
    The target population for these recommendations is patients with unresectable locally advanced, advanced, or metastatic gastroesophageal cancer. Results from testing for actionable biomarkers should be available as soon as possible to inform treatment decision making. Immunotherapy with doublet chemotherapy is recommended for patients with proficient mismatch repair (pMMR)/microsatellite stable (MSS) human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma or squamous cell carcinoma and PD-L1 expression ≥1; patients with higher PD-L1 expression are more likely to benefit from immunotherapy. Zolbetuximab is recommended for patients with gastroesophageal adenocarcinoma, PD-L1 <1, and positive CLDN18.2 expression. Patients with dual PD-L1 and CLDN18.2 positivity should engage in shared decision making, considering the factors outlined in the guideline. Doublet chemotherapy alone is recommended for patients who are not positive for actionable biomarkers or are not considered candidates for targeted therapy or immunotherapy. For patients with pMMR/MSS HER2-positive gastric/gastroesophageal junction (GEJ) adenocarcinoma, trastuzumab and doublet chemotherapy is recommended; for patients with PD-L1 expression ≥1, the addition of pembrolizumab is recommended. Immunotherapy alone or with doublet chemotherapy is recommended for patients with mismatch repair deficient/microsatellite instability-high gastroesophageal cancer. Second-line therapy options include ramucirumab with paclitaxel, trastuzumab deruxtecan for HER2-positive gastric/GEJ adenocarcinoma, and immunotherapy for PD-L1 ≥1 esophageal squamous cell carcinoma after first-line combination chemotherapy without immunotherapy.Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.
    Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability) • CLDN18 (Claudin 18)
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    PD-L1 expression • HER-2 positive • MSI-H/dMMR • HER-2 negative • CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
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    Keytruda (pembrolizumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Cyramza (ramucirumab) • Vyloy (zolbetuximab-clzb)
    9d
    Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2) (clinicaltrials.gov)
    P2, N=180, Recruiting, I-Mab Biopharma US Limited
    New P2 trial • IO biomarker
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    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
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    PD-L1 expression • CLDN18.2 positive
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    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • givastomig (TJ-CD4B)
    10d
    Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov)
    P3, N=2130, Recruiting, AstraZeneca
    New P3 trial
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    PD-L1 expression • CLDN18.2 expression • PD-L1 negative • CLDN18.2 positive • CLDN1 positive
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    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb) • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    10d
    STOPGAP II: Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity (clinicaltrials.gov)
    P2/3, N=148, Recruiting, ECOG-ACRIN Cancer Research Group | Active, not recruiting --> Recruiting
    Enrollment open
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
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    paclitaxel • 5-fluorouracil
    11d
    DUPLICATE: Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma (clinicaltrials.gov)
    P=N/A, N=70, Recruiting, European Institute of Oncology
    New trial • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative
    |
    Vyloy (zolbetuximab-clzb)