Gastroesophageal AdenocarcinomaPhase 2AACR-ADOPT-GEANCT07290985
AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas
A Phase 2 study testing Tislelizumab, Leucovorin and Oxaliplatin in people with Gastroesophageal Adenocarcinoma, run by American Association for Cancer Research at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Adenocarcinoma
- What is being tested?
- Tislelizumab, Leucovorin and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Jul 2026to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
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- 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 Exclusion criteria 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 (ISH)-positivity per central assessment) adenocarcinoma of the stomach or esophagus, including the gastroesophageal junction.
- 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).
Who cannot join
- 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).
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- 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 for all sub-studies:
- 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 excipients listed in the ingredients of any drug formulation
- 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.
- Total lifetime anthracycline load exceeding 360 mg/m² of doxorubicin or equivalent
- QTc Fridericia (QTcF) >470 ms. Note: For subjects with longer QTcF on initial electrocardiogram (ECG), follow-up ECG may be performed in triplicate to determine eligibility (e.g., after correction of electrolyte abnormalities, or discontinuation of QT-prolonging drugs).
- Ongoing Grade 2 or greater diarrhea
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
- Recruiting
Yale University
New Haven, Connecticut, 06520
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
About this study
Official title: AACR Adaptive Biomarker-Driven Organ Preservation Trial In Gastroesophageal Adenocarcinomas (AACR-ADOPT-GEA)
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.
Read the detailed description
This is a two-stage, prospective, multi-center, perioperative, biomarker-driven, open-label study. The trial design consists of a screening phase (Stage I) and a testing phase (Stage II).
Stage I:
Eligible patients will provide screening consent and research tissue for biomarker assessment. While awaiting results, they may receive one cycle of FLOT or mFOLFOX6. Once a biomarker included in the study platform is identified, patients will sign a second consent and be assigned to the corresponding subgroup. They will continue treatment with the chemotherapy backbone (mFOLFOX6) plus an immune checkpoint inhibitor and a biomarker-targeted agent. Patients who began on FLOT will switch to mFOLFOX6 once a targeted agent is added. If no actionable biomarker is detected, patients will continue standard-of-care therapy off-study. Patients receiving the chemotherapy + immune checkpoint inhibitor + targeted agent combination will complete 4 months of preoperative therapy, followed by surgery and postoperative therapy for a total treatment duration of up to one year. Once 24 patients in a given biomarker subgroup have undergone surgery, continuation to Stage II will depend on meeting predefined efficacy thresholds. Only regimens demonstrating sufficient efficacy will advance.
Stage II:
Effective therapies identified in Stage I will be further evaluated to establish predictive markers of pathological complete response (pathCR) and identify patients who may safely avoid surgery. Patients will provide tissue for central biomarker testing and may receive a chemotherapy cycle while awaiting results. Once assigned to an eligible biomarker subgroup, they will receive mFOLFOX6 + immune checkpoint inhibitor plus the targeted agent for 4 months. Response will be assessed through clinical, endoscopic, and radiologic evaluation. Patients showing no residual disease after preoperative therapy will forgo surgery and continue maintenance therapy (immune checkpoint inhibitor plus the targeted agent) for an additional 8 months with regular surveillance. Those with residual disease will proceed to surgery, followed by postoperative therapy and follow-up for up to one year.
- Conditions
- Gastroesophageal Adenocarcinoma
- Being tested
- Tislelizumab, Leucovorin, Oxaliplatin, Fluorouracil, Zanidatamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
150 mg every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively
LeucovorinDrug
400 mg/m² every 2 weeks for 4 months pre-operatively
OxaliplatinDrug
85 mg/m² every 2 weeks for 4 months pre-operatively
FluorouracilDrug
2,400 mg/m² every 2 weeks for 4 months pre-operatively
ZanidatamabDrug
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
ZolbetuximabDrug
A loading dose of 800mg/m2 zolbetuximab will be administered at cycle 1, followed by subsequent doses of 400 mg/m2 every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively. In the postoperative maintenance therapy phase, dosing of 600 mg/m2 every 3 weeks may also be used
| Study group | Role | What they receive |
|---|---|---|
| Zanidatamab + Tislelizumab (HER2) Sub-Study | Experimental | 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. Receives: Drug: Tislelizumab; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Zanidatamab |
| Zolbetuximab + Tislelizumab (CLDN18.2) Sub-Study | Experimental | Patients will receive zolbetuximab 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, zolbetuximab + tislelizumab will continue every 2 weeks for up to 1 year of perioperative therapy. Receives: Drug: Tislelizumab; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Zolbetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pathCR) Rate (Stage I).
Proportion of patients achieving a pathCR in the surgical specimen after perioperative biomarker-directed systemic therapy.
Measured: At time of surgery.
Organ Preservation Rate (Stage II)
Proportion of patients able to avoid surgery and preserve the affected organ due to biomarker-driven treatment response.
Measured: Up to 12 months post-treatment.
Secondary outcomes (7)
Event-Free Survival (Stage I).
: Time from initiation of treatment to the first documented disease progression, recurrence, or death from any cause.
Measured: Up to 24 months post-treatment.
Overall Survival (Stage I).
Time from initiation of treatment to death from any cause.
Measured: Up to 24 months post-treatment.
Tumor Regression Grade.
Assessment of tumor response in surgical specimens using National Comprehensive Cancer Network (NCCN) guidelines.
Measured: At time of surgery (Stage I).
Correlation between event-free survival and changes in circulating tumor DNA concentration.
Correlation between event-free survival (defined as time from initiation of treatment to the first documented disease progression, recurrence, or death from any cause) and plasma ctDNA concentration (mean tumor molecules per milliliter) measured using a personalized, tumor-informed assay.
Measured: Through study completion, an average of 3 years for Stage I and 6 years for Stage II.
Correlation between overall survival and changes in circulating tumor DNA concentration.
Correlation between overall survival (defined as time from initiation of treatment to death from any cause) and plasma ctDNA concentration (mean tumor molecules per milliliter) measured using a personalized, tumor-informed assay.
Measured: Through study completion, an average of 3 years for Stage I and 6 years for Stage II.
Correlation between tumor regression grade (TRG) and changes in circulating tumor DNA concentration.
Correlation between tumor regression grade (TRG 1, 2, or 3 per NCCN guidelines) and plasma ctDNA concentration (mean tumor molecules per milliliter) measured using a personalized, tumor-informed assay.
Measured: Through study completion, an average of 3 years for Stage I and 6 years for Stage II.
Treatment-Related Toxicity and Tolerability (Stage I)
Incidence and severity of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: During treatment and up to 30 days post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start20 Jul 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Association for Cancer Research
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals, BeOne Medicines, Astellas Pharma Inc, Natera, Inc., Roche Diagnostics GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290985
- Sponsor's protocol ID
- AACR-ADOPT-GEA
- Acronym
- AACR-ADOPT-GEA
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AACR Adaptive Biomarker-Driven Organ Preservation Trial In Gastroesophageal Adenocarcinomas (AACR-ADOPT-GEA)
- ClinicalTrials.gov ID
- NCT07290985
- Acronym / sponsor ID
- AACR-ADOPT-GEA / AACR-ADOPT-GEA
- Conditions
- Gastroesophageal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- American Association for Cancer ResearchUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals, BeOne Medicines, Astellas Pharma Inc, Natera, Inc., Roche Diagnostics GmbH
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a two-stage, prospective, multi-center, perioperative, biomarker-driven, open-label study. The trial design consists of a screening phase (Stage I) and a testing phase (Stage II).
Stage I:
Eligible patients will provide screening consent and research tissue for biomarker assessment. While awaiting results, they may receive one cycle of FLOT or mFOLFOX6. Once a biomarker included in the study platform is identified, patients will sign a second consent and be assigned to the corresponding subgroup. They will continue treatment with the chemotherapy backbone (mFOLFOX6) plus an immune checkpoint inhibitor and a biomarker-targeted agent. Patients who began on FLOT will switch to mFOLFOX6 once a targeted agent is added. If no actionable biomarker is detected, patients will continue standard-of-care therapy off-study. Patients receiving the chemotherapy + immune checkpoint inhibitor + targeted agent combination will complete 4 months of preoperative therapy, followed by surgery and postoperative therapy for a total treatment duration of up to one year. Once 24 patients in a given biomarker subgroup have undergone surgery, continuation to Stage II will depend on meeting predefined efficacy thresholds. Only regimens demonstrating sufficient efficacy will advance.
Stage II:
Effective therapies identified in Stage I will be further evaluated to establish predictive markers of pathological complete response (pathCR) and identify patients who may safely avoid surgery. Patients will provide tissue for central biomarker testing and may receive a chemotherapy cycle while awaiting results. Once assigned to an eligible biomarker subgroup, they will receive mFOLFOX6 + immune checkpoint inhibitor plus the targeted agent for 4 months. Response will be assessed through clinical, endoscopic, and radiologic evaluation. Patients showing no residual disease after preoperative therapy will forgo surgery and continue maintenance therapy (immune checkpoint inhibitor plus the targeted agent) for an additional 8 months with regular surveillance. Those with residual disease will proceed to surgery, followed by postoperative therapy and follow-up for up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zanidatamab + Tislelizumab (HER2) Sub-Study | Experimental | Drug: Tislelizumab, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Fluorouracil, Drug: ZanidatamabPatients 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. |
| Zolbetuximab + Tislelizumab (CLDN18.2) Sub-Study | Experimental | Drug: Tislelizumab, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Fluorouracil, Drug: ZolbetuximabPatients will receive zolbetuximab 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, zolbetuximab + tislelizumab will continue every 2 weeks for up to 1 year of perioperative therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab150 mg every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively | Drug | Zanidatamab + Tislelizumab (HER2) Sub-Study, Zolbetuximab + Tislelizumab (CLDN18.2) Sub-Study |
| Leucovorin400 mg/m² every 2 weeks for 4 months pre-operatively | Drug | Zanidatamab + Tislelizumab (HER2) Sub-Study, Zolbetuximab + Tislelizumab (CLDN18.2) Sub-Study |
| Oxaliplatin85 mg/m² every 2 weeks for 4 months pre-operatively | Drug | Zanidatamab + Tislelizumab (HER2) Sub-Study, Zolbetuximab + Tislelizumab (CLDN18.2) Sub-Study |
| Fluorouracil2,400 mg/m² every 2 weeks for 4 months pre-operatively | Drug | Zanidatamab + Tislelizumab (HER2) Sub-Study, Zolbetuximab + Tislelizumab (CLDN18.2) Sub-Study |
| Zanidatamab1,200 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 | Drug | Zanidatamab + Tislelizumab (HER2) Sub-Study |
| ZolbetuximabA loading dose of 800mg/m2 zolbetuximab will be administered at cycle 1, followed by subsequent doses of 400 mg/m2 every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively. In the postoperative maintenance therapy phase, dosing of 600 mg/m2 every 3 weeks may also be used | Drug | Zolbetuximab + Tislelizumab (CLDN18.2) Sub-Study |
Primary outcome
Pathological Complete Response (pathCR) Rate (Stage I).
Time frame: At time of surgery.
Proportion of patients achieving a pathCR in the surgical specimen after perioperative biomarker-directed systemic therapy.
Organ Preservation Rate (Stage II)
Time frame: Up to 12 months post-treatment.
Proportion of patients able to avoid surgery and preserve the affected organ due to biomarker-driven treatment response.
7 secondary outcomes
Event-Free Survival (Stage I).
Time frame: Up to 24 months post-treatment.
Overall Survival (Stage I).
Time frame: Up to 24 months post-treatment.
Tumor Regression Grade.
Time frame: At time of surgery (Stage I).
Correlation between event-free survival and changes in circulating tumor DNA concentration.
Time frame: Through study completion, an average of 3 years for Stage I and 6 years for Stage II.
Correlation between overall survival and changes in circulating tumor DNA concentration.
Time frame: Through study completion, an average of 3 years for Stage I and 6 years for Stage II.
Correlation between tumor regression grade (TRG) and changes in circulating tumor DNA concentration.
Time frame: Through study completion, an average of 3 years for Stage I and 6 years for Stage II.
Treatment-Related Toxicity and Tolerability (Stage I)
Time frame: During treatment and up to 30 days post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Leucovorin and Oxaliplatin in people with Gastroesophageal Adenocarcinoma, run by American Association for Cancer Research at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Gallagher, MS (215-446-8297, denise.gallagher@aacr.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pathCR) Rate (Stage I). (time frame: At time of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.