AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas

Part of paid clinical trials in Los Angeles, California.

Sponsor
American Association for Cancer Research
Study ID
NCT07290985
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastroesophageal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Tislelizumab — DRUG
    150 mg every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively
  • Leucovorin — DRUG
    400 mg/m² every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively
  • Oxaliplatin — DRUG
    85 mg/m² every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively
  • Fluorouracil — DRUG
    2,400 mg/m² every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively
  • Zanidatamab — DRUG
    1,200 mg for patients weighing less than 70 kg and 1,600 mg for patients weighing 70 kg or more every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively

Study Details

This study will test a new personalized treatment approach for patients with stomach or esophageal cancer. It will take place in two stages and aims to find the best combination of chemotherapy, immunotherapy, and targeted drugs based on each patient's tumor biomarkers. Upon enrollment onto the study, patients will consent to tumor biomarker testing and may receive one cycle of standard chemotherapy while awaiting results. Those with a matching biomarker will join the corresponding treatment group that combines chemotherapy, an immune checkpoint inhibitor, and/or a targeted therapy. In Stage I of the study, treatment lasts about four months before surgery, followed by an additional eight months of therapy for a total of one year. The most effective treatments from Stage I will be studied further in Stage II of the study to see whether some patients can safely avoid surgery. Those patients enrolled during Stage II will receive four months of the same combination treatment (chemotherapy, an immune checkpoint inhibitor, and/or a targeted therapy) but may be eligible to skip surgery if their cancer completely disappears after pre-surgery therapy. All patients will then receive an additional eight months of therapy and those who skipped surgery will be closely monitored with scans and endoscopies.

Key Dates

First listed
Dec 18, 2025
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Jun 1, 2028
Completion
Dec 1, 2028

Study Design

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

Arms

  • Experimental: Zanidatamab + Tislelizumab (HER2) Sub-Study
    Patients will receive zanidatamab on Day 1 of each 14-day cycle, followed by tislelizumab and mFOLFOX6 chemotherapy: leucovorin (Day 1), oxaliplatin (Day 1), and 5-FU as a 48-hour continuous intravenous infusion (Days 1-2). Up to 8 preoperative cycles will be given, followed by surgery or organ preservation if a complete response is achieved. Post-surgery or organ preservation, zanidatamab + tislelizumab will continue every 2 weeks for up to 1 year of perioperative therapy.

Primary Outcome Measure

Pathological Complete Response (pathCR) Rate (Stage I). [ Time Frame: At time of surgery. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
Yale UniversityNew HavenConnecticut06520-

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By research site
University of California, Los Angeles· Los Angeles, CAYale University· New Haven, CT

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