OncoMatch/Clinical Trials/NCT07059299
A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Plus FLOT for Resectable Esophagogastric Adenocarcinoma
Is NCT07059299 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Tislelizumab and FLOT Chemotherapy for esophagogastric junction adenocarcinoma.
Treatment: Tislelizumab · FLOT Chemotherapy — With this trial, we aim to evaluate a new combination therapy with tislelizumab and FLOT chemotherapy before surgery (neoadjuvant) for locally advanced, resectable adenocarcinoma of the esophagus or stomach (EGA). The aim of this phase Ib trial is to determine whether this combination is safe and clinically active enough to support the continuation of this concept in subsequent trials investigating novel drug combinations in the neoadjuvant setting of locally advanced EGA. As many patients are unable to tolerate the postoperative part of the standard therapy concept, we aim here to assess a prolongation of preoperative therapy to 6 or 8 applications of FLOT, instead of the routinely administered 4 pre- and 4 postoperative applications, in combination with tislelizumab.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (CPS) testing required (testing required; no eligibility threshold specified)
Tumor material is available for local assessment of PD-L1 (CPS)
Required: MSH2 dMMR/MSI-status testing required (testing required; no eligibility threshold specified)
Tumor material is available for local assessment of...dMMR/MSI-status
Disease stage
Required: Stage CT2-4, ANY CN, M0, ANY CT, CN+, M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Patient received previous (radio)chemotherapy or immunotherapy for the same condition
Cannot have received: immunotherapy
Patient received previous (radio)chemotherapy or immunotherapy for the same condition
Cannot have received: chemotherapy
Patient received previous (radio)chemotherapy or immunotherapy...within the past five years for any other cancerous condition
Cannot have received: immunotherapy
Patient received previous (radio)chemotherapy or immunotherapy...within the past five years for any other cancerous condition
Cannot have received: radiation therapy
Patient received previous (radio)chemotherapy or immunotherapy for the same condition
Cannot have received: radiation therapy
Patient received previous (radio)chemotherapy or immunotherapy...within the past five years for any other cancerous condition
Cannot have received: surgery
Patient received prior partial or complete esophagogastric resection
Lab requirements
Blood counts
ANC > 1,500 cells/μL without the use of hematopoietic growth factors; Platelet count ≥ 100 x 10^9/L (>100,000 per mm3); Hemoglobin ≥ 9 g/dL
Kidney function
Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 50 mL /min
Liver function
Serum total bilirubin ≤ 1.5x institutional ULN; AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN
Cardiac function
LVEF value < 50 % as determined by echocardiography [excluded]; QTc prolongation to > 470 ms (females) or >450 ms (males) based on average of the screening triplicate 12-lead ECG [excluded]
adequate blood count, liver-enzymes, and renal function: ANC > 1,500 cells/μL... Platelet count ≥ 100 x 10^9/L... Hemoglobin ≥ 9 g/dL... Serum total bilirubin ≤ 1.5x institutional ULN... AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN... INR ≤ 1.5 ULN and aPTT ≤ 1.5 ULN... Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 50 mL /min... LVEF value < 50 % as determined by echocardiography [excluded]; QTc prolongation to > 470 ms (females) or >450 ms (males) based on average of the screening triplicate 12-lead ECG [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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