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Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

StatusActive, Not Recruiting
PhasePhase 2
SponsorYu jiren
Started2023-05-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-05
Study Status, Study Design, Contacts/Locations v5
Enrollment closed, study ongoing
Primary completion 2026-02-10, at least 346 days after the final estimate of 2025-03-01
Completion pushed: 2028-03-01 → 2028-10-01
Primary completion dateestimated 2025-03-01→confirmed 2026-02-10
Start date2023-02-28→2023-05-30
Study sitesdetails revised at 8 of 8 sites
2024-09-14
Study Status v4
Re-verified, no change to tracked fields
2023-03-10
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 8 of 8 sites
2023-03-09
Not Yet Recruiting→Active, Not Recruiting Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2025-02-01→2025-03-01
Completion date2028-02-01→2028-03-01
Start dateestimated 2023-02-01→confirmed 2023-02-28
Eligibility criteria+57 characters
[...] sies specimens and surgical specimens for biomarker analysis, as well as the peripheral blood, feces and urine sample. The functions of the vital organs meet requirements as fol [...]
Study sitescontacts updated at 8 of 8 sites
2023-02-07
Study Status, Eligibility v1
Eligibility criteria-24 characters
[...] nt human thrombopoietin or granulocyte stimulating factor): . Hematological function： -White blood cell count (WBC): 3.5 × 10 ^ 9 / L ~12.0 × 10 ^ 9 / L； -Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L； -Platelet count (PLT) ≥ 100 × 10 ^ 9 / L； -Hemoglobin (Hb) ≥ 90 g / L. . Hepatic function： -Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal); -Aspartate aminotransferase (AST) ≤ 2.5 × ULN; -Alanine aminotransferase (ALT) ≤ 2.5 × ULN; -Albumin (ALB) ≥ 30 g / L. . Renal function： -Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml / min for those with creatinine level > 1. [...] [...]
2023-01-28
Original filing
This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.
Trial Details
NCT Number NCT05715931
Lead Sponsor Yu jiren
Conditions Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction, HER2-positive Gastric Cancer
Enrollment 30 participants
Start Date 2023-05-30
Primary Completion 2026-02-10 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-09