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New treatment option for Gastroesophageal Adenocarcinoma
Official title AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas
ClinicalTrials.gov ID: NCT07290985
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, being studied as a potential treatment for gastroesophageal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed, resectable adenocarcinoma of the stomach, esophagus, or gastroesophageal junction (Stage II or higher, T2N0 with high-risk...
- Complete surgical resection deemed achievable by multidisciplinary evaluation.
- Willingness to undergo tumor biopsies for biomarker analysis (HER2, FGFR2b, PD-L1, MSI) at screening, progression, or pre/post- surgery.
- Life expectancy ≥ 24 weeks. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate organ function:
You likely can't join if
- in the sub-protocol for the treatment for which they will be later assigned Additional inclusion criteria for all sub-studies:
- FFPE tumor sample tested at a central laboratory confirming PD-L1 Tumor Area Positivity (TAP) score ≥1%. Additional inclusion criteria specific to...
- Histologically confirmed diagnosis of resectable (i.e., radical surgery eligible), HER2-positive (defined as 3+ HER2 expression by IHC or 2+ HER2...
- Formalin-fixed, paraffin-embedded (FFPE) tumor sample tested at a central laboratory confirming HER2-positive status.
- Left ventricular ejection fraction (LVEF) ≥50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA). Exclusion criteria:
- Unresectable disease, peritoneal dissemination, and/or positive cytology on laparoscopy.
See the full eligibility criteria
Who can join
- Histologically confirmed, resectable adenocarcinoma of the stomach, esophagus, or gastroesophageal junction (Stage II or higher, T2N0 with high-risk features).
- Complete surgical resection deemed achievable by multidisciplinary evaluation.
- Willingness to undergo tumor biopsies for biomarker analysis (HER2, FGFR2b, PD-L1, MSI) at screening, progression, or pre/post- surgery.
- Life expectancy ≥ 24 weeks. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate organ function:
- Hematologic: absolute neutrophil count (ANC) ≥1.5 ×10⁹/L, platelets ≥100 ×10⁹/L, hemoglobin ≥ 8 g/dL
- Hepatic: aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤2.5 × ULN, total bilirubin ≤1.5 × upper limit of normal (ULN) (≤2.5 × ULN for Gilbert's)
- Renal: creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min/1.73 m²
- Willingness for blood samples to be drawn for research purposes.
- Baseline dihydropyrimidine dehydrogenase (DPD) testing per local guidelines; dosing of 5-FU adjusted for deficiency.
- Use of two effective contraception methods for women of childbearing potential and men during and 4 months after study; pregnant or breastfeeding women excluded.
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Willingness and able to comply with the protocol for the duration of the study, including attending scheduled visits, examinations, the screening procedure, and having their tumor and blood molecularly characterized.
- Understands they must meet all Inclusion and
What rules you out
- in the sub-protocol for the treatment for which they will be later assigned Additional inclusion criteria for all sub-studies:
- FFPE tumor sample tested at a central laboratory confirming PD-L1 Tumor Area Positivity (TAP) score ≥1%. Additional inclusion criteria specific to HER2 sub-study:
- Histologically confirmed diagnosis of resectable (i.e., radical surgery eligible), HER2-positive (defined as 3+ HER2 expression by IHC or 2+ HER2 expression by immunohistochemistry (IHC) with in situ hybridization...
- Formalin-fixed, paraffin-embedded (FFPE) tumor sample tested at a central laboratory confirming HER2-positive status.
- Left ventricular ejection fraction (LVEF) ≥50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA). Exclusion criteria:
- Unresectable disease, peritoneal dissemination, and/or positive cytology on laparoscopy.
- Peripheral neuropathy ≥ Grade 2.
- Active infection.
- Chronic growth factor support for white blood cells or granulocytes.
- Concurrent anti-cancer therapy (exceptions: supportive care medications ≥1 month prior, low molecular weight heparin, prior adjuvant hormonal therapy \>3 years, palliative radiation ≤14 days prior).
- Local/systemic therapy for current gastroesophageal diagnosis (except one FLOX/ mFOLFOX6 dose during screening).
- Significant medical conditions compromising safety or protocol compliance.
- Preexisting cardiac conditions.
- Stroke, transient ischemic attack (TIA), or myocardial infarction within 6 months.
- Prior FGFR-targeted therapy.
- Prior HER2-targeted therapy (except \>5 years prior for breast cancer).
- Prior checkpoint inhibitor therapy (anti-PD-1/PD- L1/PD-L2).
- Conditions preventing safe surgery/biopsy.
- Malabsorption syndrome or inability to swallow oral medication.
- Pregnant or nursing women
- History of stem cell or organ transplant.
- Major surgery within 14 days.
- Other malignancy within 3 years (exceptions: basal/squamous cell carcinoma, in situ malignancy, low-risk prostate cancer).
- Systemic corticosteroids \>10 mg prednisone/ day or immunosuppressive therapy ≤14 days prior (exceptions: adrenal replacement, topical/ inhaled, short prophylactic courses).
- HIV with CD4 \<350, active hepatitis B or C.
- Active or relapsing autoimmune disease (exceptions: controlled type I diabetes, hypothyroidism on replacement, controlled celiac disease, mild skin disease, other non- recurrent diseases). Additional exclusion criteria...
- History of hypersensitivity or contraindications to any active substance/active ingredient of any study medication, including chemotherapy components monoclonal antibodies, recombinant proteins, and/or any of the...
- Poorly controlled seizures
- Clinically significant bleeding (CTCAE ≥ Grade 3) from the gastrointestinal (GI) tract within 4 weeks prior to enrollment.
- Administered a live vaccine ≤ 4 weeks prior to enrollment
- History of interstitial lung disease or non-infectious pneumonitis, or with severe dyspnea at rest or requiring supplementary oxygen therapy.
- Treated with another investigational product within 28 days of enrolment. Exclusion criteria specific to HER2 sub-study:
- Total lifetime anthracycline load exceeding 360 mg/m² of doxorubicin or equivalent
- QTc Fridericia (QTcF) \>470 ms. Note: For people with longer QTcF on initial electrocardiogram (ECG), follow-up ECG may be performed in triplicate to determine eligibility (e.g., after correction of electrolyte...
- Ongoing Grade 2 or greater diarrhea
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; New Haven, Connecticut, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.