Phase II Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study will evaluate the safety and efficacy of the study treatment regimens. The study includes an evaluation of rate of immune cell infiltration into the esophagogastric tumor tissue following two and four cycles of neoadjuvant therapy. Potential study participants will be assessed for eligibil...
The study will evaluate the safety and efficacy of the study treatment regimens. The study includes an evaluation of rate of immune cell infiltration into the esophagogastric tumor tissue following two and four cycles of neoadjuvant therapy. Potential study participants will be assessed for eligibility during a 28-day screening period that includes central verification of clinical stage and eligibility. Eligible patients will be enrolled and randomized to perioperative treatment with either atezolizumab with FLOT (Arm A) or FLOT alone (Arm B). Randomization will occur in a 1:1 ratio with stratification by clinical nodal stage (N+ vs. N-), location of the primary (GEJ type I vs. GEJ type II/III vs. stomach), and MSI-status (MSI / MMRd vs. MSS / MMRp). Quantitative PDL-1 mRNA expression will be performed but not used as stratification factor. Following randomization, study patients will enter the study treatment period which will last approximately 22 to 52 weeks depending on treatment arm and timing of surgery. Arm A: FLOT with Atezolizumab: Patients randomized to treatment Arm A will receive atezolizumab + FLOT in four 2-week treatment cycles as described below prior to undergoing surgery. Following surgery, patients will receive four further 2-week cycles of atezolizumab + FLOT followed by 8 additional 3-week treatment cycles with atezolizumab alone. Arm B: FLOT alone: Patients randomized to Arm B will receive FLOT alone for four 2-week treatment cycles prior to surgery. Following surgery, patients will receive four further 2-week cycles of chemotherapy alone.
Tracking Information
- NCT #
- NCT03421288
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Salah-Eddin Al-Batran, Prof. IKF Institute of Clinical Cancer Research at Krankenhaus Nordwest
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