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New treatment option for Gastric Adenocarcinoma
Official title Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)
ClinicalTrials.gov ID: NCT05177133
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for gastric adenocarcinoma.
Also referred to as Xeloda.
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
- To investigate the effects of the combination of two chemotherapies followed by immunostimulants on the interferon gamma expression and infiltration of cytotoxic T cells in the tumour microenvironment in patients with previously untreated metastatic or locally advanced esophagogastric cancer.
- 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
- Patients must provide written informed consent according to ICH/GCP, and national/local regulations prior to any screening procedures.
- Male or female adult patients (≥ 18 years).
- Patients with histologically confirmed diagnosis of metastatic or irresectable HER2 negative adenocarcinoma of the stomach or gastroesophageal...
- Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for...
- Measurable disease as assessed by RECIST 1.1
You likely can't join if
- Severe renal impairment (CLcr ≤ 30 ml/min)
- Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment.
- Any prior anti-cancer chemotherapy, biologic or investigational therapy for metastatic or irresectable stomach or oesophageal cancer
- Disease progression within six months after completion of (neo)adjuvant chemotherapy containing a fluoropyrimidine and/or platinum compound. (Disease...
- All target lesions in a radiation field without documented disease progression.
- Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no...
See the full eligibility criteria
- Patients must provide written informed consent according to ICH/GCP, and national/local regulations prior to any screening procedures.
- Male or female adult patients (≥ 18 years).
- Patients with histologically confirmed diagnosis of metastatic or irresectable HER2 negative adenocarcinoma of the stomach or gastroesophageal junction (Siewert II and III); patients with HER2 positive disease are...
- Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable or metastatic disease. Palliative radiotherapy on the primary tumor...
- Measurable disease as assessed by RECIST 1.1
- dMMR identified by IHC of mismatch repair proteins MLH1, PMS2, MSH2 en MSH6
- Primary tumor or metastasis accessible for repeat fresh histological biopsies
- ECOG (WHO) performance status 0-2
- Patient has adequate bone marrow and organ function as defined by the following laboratory values:
- Absolute Neutrophil Count (ANC) \> 1.5 x 109 /L
- Hemoglobin (Hgb) \> 5.6 mmol/L
- Platelets \> 100 x 109 /L
- Serum total bilirubin within ≤ 1.5 x ULN (upper limit of normal); or total bilirubin \< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's syndrome; biliary drainage is...
- Serum creatinine \ 30 mL/min/1.73 m2
- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 2.5x ULN within normal range or \< 5.0 x ULN if liver metastases are present
- If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative pregnancy test (urine or serum; beta-human chorionic gonadotropin (β-hCG)) documented prior to the...
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient...
- Severe renal impairment (CLcr ≤ 30 ml/min)
- Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment.
- Any prior anti-cancer chemotherapy, biologic or investigational therapy for metastatic or irresectable stomach or oesophageal cancer
- Disease progression within six months after completion of (neo)adjuvant chemotherapy containing a fluoropyrimidine and/or platinum compound. (Disease progression within 6 months after completion of neoadjuvant...
- All target lesions in a radiation field without documented disease progression.
- Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
- Past or current malignancy other than entry diagnosis interfering with prognosis of metastatic gastroesophageal cancer.
- Known uncontrollable hypersensitivity or contraindications to any of the components of retifanlimab, fluoropyrimidines, leucovorin, oxaliplatin. Patients with previous dose reductions or delays are eligible.
- Complete dihydropyrimidine dehydrogenase deficiency.
- Patient has active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy.
- Patient has known past or active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Signs of interstitial lung disease (ILD)
- Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or...
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation in the clinical study.
- Use of other investigational drugs within 30 days of enrollment.
- Patient is enrolled in any other clinical protocol or investigational trial that will interfere with the primary endpoint of the current study.
- Patients who in the investigators' opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol.
- Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of study treatment.
- Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.
- Pre-existing motor or sensory neurotoxicity greater than CTCAE grade 1.
- History of organ transplant, including allogeneic stem cell transplantation.
- Receiving probiotics as of the first dose of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Eindhoven, Netherlands
- Leeuwarden, Netherlands
- Leiden, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
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 Amsterdam, Netherlands; Eindhoven, Netherlands; Leeuwarden, Netherlands; Leiden, Netherlands; Nijmegen, Netherlands; Rotterdam, Netherlands and 1 more location(s). 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.