Pancreatic cancer
Conditions
Interventions
Intervention Group:GnP chemotherapy (nab-paclitaxel plus gemcitabine) combined with serplulimab and stereotactic body radiotherapy (SBRT)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Metastatic pancreatic cancer that is pathologically diagnosed as adenocarcinoma, diagnosis combined with pathology and imaging (CT or MRI) for comprehensive assessment; 2.Patients without prior history of antitumour treatment (Including chemotherapy, radiation therapy, or other research-oriented treatments) ,OR patients who have undergone radical surgery followed by adjuvant therapy can be screened if they meet the following conditions: (1)The last adjuvant chemotherapy was administered more than 6 months before relapse. (2) The last radiotherapy was administered more than 2 years before enrollment in this study, or there is no overlap between the target area in our study and the area previously treated with radiotherapy; 3.Age between 18 years old and 80 years regardless of gender; 4.ECOG PS score: 0 to 2; 5.At least one measurable tumor lesion: on spiral CT, the long diameter >= 10 mm and the short diameter of lymph nodes >= 15 mm; Ordinary CT or physical examination, the maximum diameter must be >= 20mm; 6.Normal function of main organs: (1) Adequate bone marrow function (no transfusion within 14 days prior to screening): WBC >= 4.0x10^9/L; ANC >=1.5x10^9/L; PLT >=80x10^9/L; Hb >= 90 g/L; (2) Acceptable liver function: ALT and AST =60 ml/min/1.73m^2; (4) Acceptable coagulation function: PT, APTT, and INR 1.5xULN are permissible, provided that researchers can provide adequate justification; (5) Serum electrolytes: Serum concentrations of sodium, potassium, calcium, and magnesium are within the range of NCI-CTCAE version 5.0 grade 1; (6) ECG: QTc interval =3 months; 9.Prior to the commencement of any study-related assessments or procedures, it is imperative that individuals comprehend and willingly sign an informed consent document.
Exclusion criteria
Exclusion criteria: 1.Previous allergic reactions to research drugs; 2.New known or suspected central nervous system (CNS) metastasis [Subjects with signs or symptoms indicating central nervous system metastasis, unless central nervous system metastasis is ruled out through CT or MRI]; 3.Synchronous or metachronous malignancies within 5 years (except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4.Concurrent other kinds of antitumour treatments such as chemotherapy, radiotherapy, targeted therapy, hormonal therapy, immunotherapy, Chinese traditional medicine during the studytrial course; 5.Prior use of FAK inhibitors, anti-PD-1 agents, anti-PD-L1 agents, anti-PD-L2 agents, anti-CD137 agents, or CTLA-4 inhibitors, (including ipilimumab or any other antibodies or agents targeting costimulatory or checkpoint pathways of T cell); 6.Diagnosed with immunodeficiency or treated with systemic steroids (daily administration of more than 10 milligrams of prednisone or equivalent) or other forms of immunosuppressive therapy within 7 days prior to the first administration, are included in the study population; 7.History of receiving live vaccines (including but not limited to: measles, mumps, rubella, chickenpox/shingles, yellow fever, rabies, BCG, and typhoid vaccines)within 30 days before the first administration [virus-based (killed) vaccines are allowed, but live attenuated vaccines are not allowed]; 8.Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg after treatment) 9.Significant cardiac disease, including congestive heart failure (NYHA III-IV grade), previous myocardial infarction or uncontrolled angina in the 6 months; 10.ECG abnormalities that need clinical intervention judged by researchers(Cardiac arrhythmias that require treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation, with ECG abnormalities confirmed by follow-up and judged by the researcher to require clinical intervention or treatment); 11.History of hemorrhagic or thromboembolic events within the last 6 months; 12.Surgery required within 28 days or within 28 days after the last dose (Cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, spontaneous massive bleeding of tumors, etc); 13.Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 14.Previous or suspected gastrointestinal perforation; 15.Concurrent drugs influencing the metabolism of studytrial agents judged by researchers (For example, strong CYP 3A4 inhibitors or inducers are mainly metabolized through CYP 3A4, 2C8, 2C9, 2C19 or 2D6, as well as drugs with lower therapeutic indices); 16.Server mental disorders; 17. Females who may pregnancy, pregnancy or lactating; 18.Participating in other clinical trials within 4 weeks before the trial; 19.Participants during childbearing age are unwilling to contracept from the begin of trials to 3 months after last dose; 20.Unsuitable for enrollment assessed by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS);progression-free survival (PFS);objective response rate (ORR) assessed by researchers;disease control rate (DCR);tumor lesion-specific ORR;time to progression (TTP);duration of response (DOR);duration of disease control (DDC);safety ;BIRC assessed-overall response rate (ORR); | — |
Countries
China
Contacts
Public ContactCao Dan
West China Hospital, Sichuan University
Outcome results
None listed