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Tests treatment safety and results for Esophagogastric Junction Adenocarcinoma
Official title A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Plus FLOT for Resectable Esophagogastric Adenocarcinoma
ClinicalTrials.gov ID: NCT07059299
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, being studied as a potential treatment for esophagogastric junction 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
- 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.
- Phase 1: an early, usually small safety study
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
- Patient\ has given written informed consent.
- Patient is ≥ 18 years of age at time of signing the written informed consent.
- Patient has histologically proven locally advanced (cT2-4 , any cN , M0 OR any cT, cN+, M0 stage) gastric, esophageal or esophagogastric junction...
- Is considered technically resectable.
- Does not involve distant site of the peritoneal cavity.
You likely can't join if
- Patient received previous (radio)chemotherapy or immunotherapy for the same condition or within the past five years for any other cancerous condition.
- Patient received prior partial or complete esophagogastric resection.
- Patient has known hypersensitivity to any component of the tislelizumab formulation as well as a known history of severe allergic, anaphylactic, or...
- Patient has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung...
- Patient has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g...
- Patient has inadequate cardiac function (LVEF value \< 50 %) as determined by echocardiography.
See the full eligibility criteria
Who can join
- Patient\ has given written informed consent.
- Patient is ≥ 18 years of age at time of signing the written informed consent.
- Patient has histologically proven locally advanced (cT2-4 , any cN , M0 OR any cT, cN+, M0 stage) gastric, esophageal or esophagogastric junction adenocarcinoma that:
- Is considered technically resectable.
- Does not involve distant site of the peritoneal cavity.
- confirmed by diagnostic laparoscopy for all patients with tumors located in the stomach and those with type 2 and 3 GEJ adenocarcinomas according to ESMO guideline recommendation [Lordick et al. 2022].
- Type 1 GEJ and esophageal adenocarcinomas can be enrolled without diagnostic laparoscopy (which is in line with guidelines and the current routine practice in Germany).
- Tumor material is available for local assessment of PD-L1 (CPS) and dMMR/MSI-status at the investigator´s site.
- Patient has an ECOG performance status 0 or 1.
- Patients has adequate blood count, liver-enzymes, and renal function:
- ANC (Absolute neutrophil count) \> 1,500 cells/μL without the use of hematopoietic growth factors.
- Platelet count ≥ 100 x 10\^9/L (\>100,000 per mm3).
- Hemoglobin ≥ 9 g/dL.
- Serum total bilirubin ≤ 1.5x institutional upper normal limit (ULN).
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN.
- Patients not receiving therapeutic anticoagulation must have an INR ≤ 1.5 ULN and aPTT ≤ 1.5 ULN. The use of full dose anticoagulants is allowed (according to the medical standard in the institution) and the patient has...
- Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 50 mL /min.
- Female patients defined as women of childbearing potential (WOCBP) must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year...
- There are no data that indicate special gender distribution. Therefore, patients will be enrolled gender-independently in this trial.
What rules you out
- Patient received previous (radio)chemotherapy or immunotherapy for the same condition or within the past five years for any other cancerous condition.
- Patient received prior partial or complete esophagogastric resection.
- Patient has known hypersensitivity to any component of the tislelizumab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or...
- Patient has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Patient has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within three months of the study randomization, severe...
- Patient has inadequate cardiac function (LVEF value \< 50 %) as determined by echocardiography.
- Patient has a known complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
- Patient received treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to study enrollment.
- Patients has pernicious anemia or other megaloblastic anemia due to vitamin B12 deficiency.
- Patient has peripheral sensitive neuropathy with functional deficits.
- Patient has a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF; New York Heart Association Class II to IV). people with troponin levels above ULN...
- Patient has a corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (males) based on average of the screening triplicate12-lead ECG.
- Participant has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or...
- Patient has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Patient has active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C (HBV/HCV) infection. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA...
- HBsAg(-) (for \> 6 months off anti-viral treatment)
- Anti-HBc(+) (IgG or total Ig)
- HBV DNA undetectable
- Absence of cirrhosis or fibrosis on prior imaging or biopsy
- Absence of HCV co-infection or history of HCV co-infection
- Access to a local hepatologist during and after the study
- Patient has active or history of autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease...
- Patient received treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within four weeks or five half-lives of the drug, whichever is longer, prior to study...
- Patient received treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to study enrollment. The use of inhaled corticosteroids and mineralocorticoids (e.g...
- Patient received prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Patient received live, attenuated vaccine within 30 days prior initiation of study drug.
- Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect.
- Patient participated in another treatment clinical study according to Medicines Act within 28 days prior to study enrollment or participation in a clinical study according to Medicines Act at the same time as this study...
- Patient has taken an investigational drug within 28 days prior to initiation of study drug.
- Female patients, who are pregnant or breast feeding or planning to become pregnant within 7 months after the last dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy...
The study team makes the final eligibility decision.
Where it's taking place
- Frankfurt, Germany
- Hamburg, Germany
- Leipzig, Germany
- München, Germany
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 Frankfurt, Germany; Hamburg, Germany; Leipzig, Germany; München, Germany. 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.