View clinical trials related to HER2-positive Gastric Cancer.
Filter by:TRINITY is designed as a multicentre, randomized, open-label, interventional phase II study aimed at investigating the activity, efficacy and safety of trastuzumab-deruxtecan (T-DXd) plus capecitabine/5-fluorouracil as a post-operative treatment in localized/locally advanced gastric or gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma patients with HER2 overexpression/amplification and positive post-operative ctDNA after pre-operative 5-fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) regimen followed by radical surgery.
This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Disitamab Vedotin in Combination With Tirelizumab and S-1 as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.
To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.
Investigators assessed the effectiveness of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer
Study Design: This is a Phase II study to assess the safety and clinical efficacy of this combined chemotherapy-free regimen (zanidatamab and tislelizumab) in HER2-positive advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma after first line treatment. The study will be conducted as phase II study to evaluate the safety and tolerability of the combination treatment of zanidatamab and tislelizumab and determine anti-tumor activity in HER2-positive advanced gastric/GEJ adenocarcinoma patients. This study will be conducted at up to 6 medical centers in Korea. Patients who are HER2-positive will be confirmed by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH)/silver in situ hybridization (SISH) at local laboratory. Patients who meet all eligibility criteria will be enrolled to this study and receive treatment with zanidatamab and tislelizumab until progressive disease is confirmed or at least 1 discontinuation criterion is met. Study Assessments: Patients will be monitored for safety, tolerability, and antitumor activity throughout the study. Safety will be assessed throughout the study by monitoring AEs/SAEs, and laboratory results. Vital signs, physical examinations, Eastern Cooperative Oncology Group (ECOG) performance status change, ECG results, echocardiogram/MUGA, and other examinations will also be used for safety assessment. Anticancer activity will be evaluated by the investigator using RECIST 1.1. Radiological assessment of tumor response status will be performed every 6 weeks (±7 days) from (anchored to) Cycle 1 Day 1 for the first 54 weeks and every 12 weeks (±7 days) thereafter until disease progression, withdrawal of consent, death, or start of a new anticancer therapy. Patients who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original plan until the patient begins a subsequent anticancer treatment, experiences disease progression, withdraws consent, is lost to follow up, death, or until the study terminates, whichever occurs first. Duration of Patient Participation: Screening Period is within 28 days prior to the first dose of study drug. Treatment Period starts with the first dose administration of study drug and ends when the patient is discontinued for study treatment when they are no longer considered to be achieving clinical benefit due to confirmed disease progression or unacceptable toxicity, or due to death or withdrawal of consent. Safety Follow-up. Patients who discontinue treatment for any reason will be asked to return to the clinic for the Safety Follow up Visit (to occur approximately 30 days (±7 days] after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first). In addition, telephone contacts with patients treated with zanidatamab and tislelizumab should be conducted to assess immune-mediated AEs and concomitant medications (if applicable, i.e. associated with an immune-mediated AE or is a new anticancer therapy) at 60 (±14 days) and 90 days (±14 days) after the last dose of study drug(s) regardless of whether the patient starts a new anticancer therapy. Survival Follow-up. Patients will be followed for survival and further anticancer therapy information after discontinuation of study treatment via telephone calls, patient medical records, and/or clinic visits approximately every 3 months (±14 days) after the Safety Follow-up Visit or as directed by the investigator until death, loss to follow-up, withdrawal of consent, or study completion.
The positive rate of HER2 in Chinese patients with gastric cancer is about 12-13%. HER2 positive gastric cancer has strong invasion, high metastasis rate and poor prognosis. The effective rate of chemotherapy combined with anti-HER2 targeted therapy for HER2 positive advanced gastric cancer was 47%, and the median survival time was extended to 13.8 months. However, the status of HER2 in advanced gastric cancer has obvious temporal and spatial heterogeneity, and the heterogeneity of HER2 directly affects the outcome of anti-HER2 treatment. Therefore, compared with biopsy pathology, it is urgent to explore noninvasive, systemic and repeatable methods to evaluate HER2 status of systemic lesions. 68Ga-HER2 Affibody-BCH, a HER2 imaging agent, was independently prepared by the Department of nuclear medicine of our center. According to the results of preclinical studies, in patients with HER2 positive advanced gastric cancer, the imaging effect was the best 2 hours after intravenous injection of 68Ga-HER2 Affibody and there was no adverse reaction. 68Ga-HER2 Affibody PET/CT imaging can directly reflect the HER2 heterogeneity within the same lesion and between the primary and metastatic lesions. In order to solve the clinical problems, this study intends to further explore the imaging of 68Ga-HER2 Affibody-BCH in patients with advanced gastric cancer and the amplification of HER2 in the peripheral blood of this population, so as to overcome the heterogeneity of HER2, explore the potential beneficiaries of anti HER2 treatment, and provide the basis for the evaluation of anti-HER2 treatment efficacy.