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Pre-operative capecitabine, oxaliplatin, docetaxel and atezolizumab in gastric cancer (PANDA)
EU CTIS ID: 2024-519075-26-00
What this study is testing
To explore the safety and feasibility of neoadjuvant capecitabine, oxaliplatin, docetaxel, and atezolizumab in GE-junction and gastric adenocarcinoma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent
- Patients must be willing to undergo esophagogastroscopy and biopsies prior to start of treatment and during treatment at defined timepoints
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days prior to the start of treatment
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving atezolizumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception)
- For women of childbearing potential*: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the last dose of atezolizumab after the last dose of atezolizumab (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices)
- Primary resectable, histologically confirmed gastric or gastro-esophageal junction adenocarcinoma
You likely can't join if
- Clinical symptoms or radiological suspicion of perforation
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
- Current treatment with anti-viral therapy for HBV
- Treatment with investigational therapy within 28 days prior to initiation of study treatmen
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies
See the full eligibility criteria
Who can join
- Signed informed consent
- Patients must be willing to undergo esophagogastroscopy and biopsies prior to start of treatment and during treatment at defined timepoints
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days prior to the start of treatment
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving atezolizumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception)
- For women of childbearing potential*: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the last dose of atezolizumab after the last dose of atezolizumab (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices)
- Primary resectable, histologically confirmed gastric or gastro-esophageal junction adenocarcinoma
- ECOG performance status of 0 or 1
- Patients age 18 and older
- No signs of distant metastases
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: o ANC ≥ 1.5 × 109 /L (1500/µL) without granulocyte colony-stimulating factor support o Lymphocyte count ≥ 0.5 × 109 /L (500/µL) o Platelet count ≥ 100 × 109 /L (100,000/µL) without transfusion o Hemoglobin ≥ 5,6mmol/L (patients may be transfused to meet this criterion) o AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN) o Serum bilirubin ≤ 1.5 × ULN except for patients with known Gilbert disease: serum bilirubin level ≤ 3 × ULN o Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 40 mL/min (calculated using the Cockcroft-Gault formula) o Serum albumin ≥ 25 g/L o For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 × ULN
- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- CT-scan of thorax and abdomen < 4 weeks to registration. PET-scan and EUS are required for GEJ tumors and are optional for gastric cancers
- For diffuse type gastric cancers, diagnostic laparoscopy should be performed and show no signs of peritoneal metastases
What rules you out
- Clinical symptoms or radiological suspicion of perforation
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
- Current treatment with anti-viral therapy for HBV
- Treatment with investigational therapy within 28 days prior to initiation of study treatmen
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- Conditions requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
- Intercurrent illnesses, including but not limited to infections, that are determined incompatible with the study treatment and protocol by the study team
- Signs or suspicion of metastatic disease
- Underlying medical conditions that will make the administration of the study drug hazardous or obscure the interpretation of toxicity determination of adverse events
- Positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
- History of testing positive human immunodeficiency virus or known acquired immunodeficiency syndrome (AIDS)
- History of uncontrolled medical or psychiatric illness. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within months after the last dose of study treatment
- History of malignancy within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Active tuberculosis
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- Major surgical procedure other than diagnostic laparoscopy, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure, other than for this diagnosis, during the study
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Prior allogeneic stem cell or solid organ transplantation
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.