Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT06731803
Brief Summary:
The study is a phase Ib/II, prospective, single arm, open label, non-randomized, multi-center platform trial assessing the feasibility and safety of different neoadjuvant trastuzumab-deruxtecan containing combinational treatment regimens in patients with HER2 positive, locally advanced, resectable esophagogastric adenocarcinoma
Detailed Description:
The NeoART trial consists of cohorts focusing on distinct trastuzumab-deruxtecan (T-DXd) combination therapies. Enrolment of patients in the two currently defined cohorts will be consecutive, i.e., recruitment for NeoART-002 will start after full recruitment of NeoART-001.
All eligible patients in NeoART-001 cohort will receive: Trastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus 5-FU/LV: leucovorin 200 mg/m2 i.v., followed by 5-fluorouracil (5-FU) 2600 mg/m2 as a 24-h continuous infusion on day 1, Q2W. Patients will receive three cycles of neoadjuvant T-DXd combined with four cycles 5-FU/LV followed by surgery. Surgery will be scheduled 3-4 weeks after completion of the last cycle of preoperative study therapy.
All eligible patients in NeoART-002 cohort will receive: Trastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus FLO:oxaliplatin 85 mg/m2 \& leucovorin 200 mg/m2, each as an i.v. infusion followed by 5-FU 2600 mg/ m2 as a 24-h continuous infusion on day 1, Q2W. Patients will receive three cycles of neoadjuvant trastuzumab-deruxtecan combined with four cycles FLO followed by surgery.
Surgery will be scheduled 3-4 weeks after completion of the last cycle of preoperative study therapy.
The primary objective of the trial is to evaluate the feasibility and safety (primary endpoint: feasibility rate) of different neoadjuvant T-DXd containing combinational treatment regimens in patients with HER2 positive, locally advanced, resectable esophagogastric adenocarcinoma. The secondary objectives are to futher characterize the efficacy of different neoadjuvant trastuzumab-deruxtecan containing combinational treatment regimens and to evaluate safety and tolerability of different neoadjuvant T-DXd containing combinational treatment regimens. Secondary endpoints comprise the assessment of toxiticy, Perioperative morbidity, Pathological complete remission and R0 resection rate.
Up to 18 patients will be enrolled into each cohort.
Study:
NCT06731803
Study Brief:
Protocol Section:
NCT06731803