^
    18d
    Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Jeeyun Lee | N=50 --> 100
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 positive • CLDN18.2 positive
    |
    Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    18d
    Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer (clinicaltrials.gov)
    P2, N=2, Active, not recruiting, National Cancer Institute (NCI) | N=240 --> 2 | Trial completion date: Oct 2027 --> Jun 2027 | Trial primary completion date: Oct 2027 --> Jan 2026
    Enrollment change • Trial completion date • Trial primary completion date • MSI-H • dMMR
    |
    MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    MSI-H/dMMR
    |
    Tecentriq (atezolizumab) • docetaxel • capecitabine • oxaliplatin • leucovorin calcium • fluorouracil topical
    18d
    A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer (clinicaltrials.gov)
    P3, N=1000, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    18d
    Trastuzumab rezetecan versus pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer (HORIZON-Breast01): interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol)
    Trastuzumab rezetecan improved progression-free survival versus pyrotinib plus capecitabine and showed a distinct safety profile in patients with HER2-positive breast cancer, presenting as a potential new treatment option.
    P3 data • P3 data: top line • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • capecitabine • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
    19d
    Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=66, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
    |
    capecitabine • oxaliplatin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    19d
    Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy as First-line Treatment for Advanced Gastric Cancer With Liver Metastases (clinicaltrials.gov)
    P3, N=332, Not yet recruiting, Peking University
    New P3 trial
    |
    Tyvyt (sintilimab) • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • retlirafusp alfa (SHR-1701)
    19d
    Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer (clinicaltrials.gov)
    P1/2, N=186, Recruiting, Zhejiang Doer Biologics Co., Ltd. | Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative • HER-2 expression
    |
    5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium
    20d
    A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor (clinicaltrials.gov)
    P1/2, N=120, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • capecitabine • albumin-bound paclitaxel • trastuzumab rezetecan (SHR-A1811)
    20d
    Tucatinib in patients with HER2-positive advanced/metastatic breast cancer: A systematic literature review of real-world evidence. (PubMed, Breast)
    Overall, the available real-world evidence supports the clinical effectiveness of tucatinib-based therapies in HER2+ MBC, including heavily pretreated populations, patients with prior exposure to T-DXd, and those with brain metastases. However, gaps remain in the real-world data regarding the safety profile of tucatinib and its impact on health-related quality of life in routine clinical practice.
    Review • Journal • HEOR • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Tukysa (tucatinib)
    20d
    Comparative efficacy of tislelizumab + FOLFOX or CAPOX for gastric/gastroesophageal junction adenocarcinoma: an exploratory matching-adjusted indirect comparison. (PubMed, Curr Med Res Opin)
    In the RATIONALE-305 trial, first-line tislelizumab + chemotherapy (CAPOX ([capecitabine + oxaliplatin] or 5-fluorouracil [5-FU] + cisplatin) significantly improved overall and progression-free survival (PFS) versus placebo + chemotherapy in unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric/gastroesophageal junction cancer (GC/GEJC). This exploratory analysis evaluated the comparative efficacy of tislelizumab + CAPOX versus tislelizumab + CAPOX or FOLFOX (5-FU, leucovorin, oxaliplatin) using a matching-adjusted indirect comparison (MAIC) approach...Although median PFS was numerically longer with the mixed chemotherapy backbone, these findings are exploratory in nature and warrant further investigation. ClinicalTrials.gov, RATIONALE-305 (NCT03777657); DisTinGuish (NCT04363801).
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    cisplatin • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • leucovorin calcium
    20d
    A phase II study of alpelisib and capecitabine in patients with previously treated metastatic colorectal cancer (KCSG-CO21-04). (PubMed, Sci Rep)
    Overall, alpelisib combined with capecitabine demonstrated modest antitumor activity in a molecularly selected subset of patients with metastatic colorectal cancer. However, frequent treatment-limiting toxicities may limit the future clinical applicability of this regimen and highlight the need for improved toxicity management and optimized patient selection.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    capecitabine • Piqray (alpelisib)
    20d
    DESTINY Breast Respond HER2-(Ultra)Low Europe (clinicaltrials.gov)
    P=N/A, N=2295, Recruiting, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | N=1155 --> 2295 | Trial completion date: Sep 2028 --> Dec 2030 | Trial primary completion date: Sep 2028 --> Dec 2030
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • albumin-bound paclitaxel • eribulin mesylate