Gastric Cancer
Conditions
Interventions
Treatment group:Pembrolizumab plus Maraviroc
Sponsors
Shanghai Tenth Peoples' Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed metastatic gastric cancer; 2. ECOG performance status 0 or 1 3. Female and male patients = 18 years. 4. Measurable disease as per RECIST 1.1 5. Patient failed standard therapy or refused standard therapy or is intolerable towards standard therapy; 6. Adequate hematological, hepatic and renal function parameters: Leucocytes> 3.000/ul; Hemoglobin >9 g/dl; Thrombocytes > 100.000/ul; Serum creatinine = 1.5 x upper limit of normal (ULN) or GFR =60 mL/min for subject with creatinine levels > 1.5 x institutional ULN;Serum total bilirubin = 1.5 x upper limit of normal or direct bilirubin = ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT = 2.5 x upper limit of normal (or = 5 x if liver metastases are present); Albumin = 2.5 mg/dL; Adequate coagulation functions as defined by International Normalized Ratio (INR) =1.5, and a partial thromboplastin time (PTT) = 5 seconds above the ULN (unless receiving anticoagulation therapy); 7. Patients receiving warfarin/ phenprocoumon must be switched to low molecular weight heparin and have achieved stable coagulation profile; 8. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.
Exclusion criteria
Exclusion criteria: 1. Inability to understand the aims of the study and/or protocol procedures; 2. Hypersensitivity towards pembrolizumab, maraviroc, or any ingredients of the formulations administeredHistory of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies. Any other concurrent antineoplastic treatment including irradiation (local radiation of single non-target lesions for palliation only allowed). Active autoimmune disease requiring immunosuppressive therapy; 3. Any condition requiring continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease; 4. Secondary malignant disease during the last 5 years (exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy); 5. Clinical relevant comorbidity also including significant psychiatric disease; 6. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV; 7. Cardiocirculatory insufficiency with hypotension (systolic blood pressure Grade A), pronounced alcohol abuse with anticipated detoxification, severe pulmonary infection with considerable reduction of pulmonary function; 9. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy and have no evidence of disease progression on imaging studies (MRI/CT scan); 10. On-treatment participation in another clinical study in the period 30 days prior to start of study treatment and during the study; 11. Patients in a closed institution according to an authority or court decision; 12. Pregnancy or lactation; 13. Known history of, or any evidence of active, non-infectious pneumonitis or interstitial lung disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and toxicity;Efficacy; | — |
Countries
China
Contacts
Public ContactTingsong Yang
Shanghai Tenth Peoples' Hospital
Outcome results
None listed