A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Plus FLOT for Resectable Esophagogastric Adenocarcinoma

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT07059299
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Esophageal Adenocarcinoma
  • Esophagogastric Junction Adenocarcinoma
  • Gastric Adenocarcinoma
  • Neoadjuvant Therapy
  • Resectable Esophagogastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    humanized immunoglobulin G4 (IgG4)-variant monoclonal antibody (mAb) against human programmed cell death-1 (PD-1)
  • FLOT Chemotherapy — DRUG
    docetaxel 50 mg/m², oxaliplatin 85 mg/m², leucovorin 200 mg/m² and 5-FU 2600 mg/m², all i.v. on day 1 Q2W

Study Details

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.

Key Dates

First listed
Jul 10, 2025
Start date
Dec 12, 2025
Status verified
Dec 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose intensification (Level 1 and 2)
    In the dose intensification part of the trial, eligible patients will be enrolled in a staggered approach with 6 patients for each successive dose level: Dose level 1 (n=6): * 4 cycles tislelizumab (200 mg, i.v. on day 1 Q3W ) plus * 6 cycles: FLOT (docetaxel 50 mg/m², oxaliplatin 85 mg/m², leucovorin 200 mg/m² and 5-FU (5-fluorouracil) 2600 mg/m², all i.v. on day 1 Q2W) Dose level 2 (n=6): * 5 cycles tislelizumab (200 mg, i.v. on day 1 Q3W) plus * 8 cycles: FLOT (docetaxel 50 mg/m², oxaliplatin 85 mg/m², leucovorin 200 mg/m² and 5-FU 2600 mg/m², all i.v. on day 1 Q2W) The maximum dose level at which one or less out of 6 patients experienced a DLT is considered an optimal dose. In the expansion part of the trial, the dose level classified as optimal dose will be extended by a further 6 patients (12 patients in total for the optimal dose level).

Primary Outcome Measure

Feasibility rate [ Time Frame: up to 8 months ]

Central Contacts

Related Studies