Pancreatic cancer
Conditions
Interventions
Experimental group:Tumor Electric Field Treatment+first-line chemotherapy
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 years old (inclusive) to 75 years old (inclusive), gender is not limited. 2. Life expectancy =3 months. 3. Histologic/cytologic diagnosis of new adenocarcinoma of the pancreas. 4. unresectable locally advanced disease according to the following criteria: Pancreatic head/neck tumors: a. Tumor touches the superior mesenteric artery (SMA) by more than 180°. b. Tumor touches the celiac trunk by more than 180°. c. Tumor invasion or embolization (tumor thrombus or thrombus) resulting in unresectable reconstruction of the superior mesenteric vein or portal vein. d. Tumor extensively touches the distal jejunal drainage branch of the superior mesenteric vein. Pancreatic body/tail tumors: a. Tumor touches the superior mesenteric artery or celiac trunk by more than 180°. b. Involvement of the celiac trunk and abdominal aorta. c. Tumor invasion or embolization (tumor thrombus or thrombus) resulting in unresectable reconstruction of the superior mesenteric or portal veins. No distant metastasis, including non-regional lymph node metastasis 5. ECOG score of 0-2. 6. No large amount of ascites or pleural effusion. 7. Obedience to the treatment specified by the investigator. 8. Voluntarily participate in this clinical trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received prior tumor treatment: a. Received systemic therapy for pancreatic adenocarcinoma. b. Received radiation therapy prior to abdominal surgery. c. Received radical surgery for pancreatic cancer. d. Patients who have had major surgery (other than diagnostic biopsy) within 4 weeks prior to the start of treatment, or who have not fully recovered from surgery. 2. Diagnosed cancer requiring antitumor therapy within 5 years prior to study entry, excluding treated stage I prostate cancer, cervical cancer in situ, breast cancer in situ, and non-melanoma skin cancer. 3. have serious comorbidits: a. Have clinically significant hematologic, hepatic and renal insufficiency(determined by the investigator) , defined as: neutrophil count 1.5 × upper limit of normal (ULN); AST and/or ALT >2.5 × ULN; serum creatinine >1.5 × ULN. b. Have history of significant cardiovascular disease unless the disease is well controlled. Serious cardiac disease includes second/third degree heart block; severe ischemic heart disease; poorly controlled hypertension; New York Heart Association (NYHA) class II or worse congestive heart failure (mild limitation of physical activity; no discomfort at rest but daily activities cause fatigue, palpitations, or dyspnea). c. Have history of arrhythmias that are symptomatic or require treatment. Patients with atrial fibrillation or atrial flutter controlled by medication will not be excluded from the study. d. Have history of cerebrovascular accident (CVA) or unstable CVA within 6 months prior to enrollment. e. Presence of an active infection or serious underlying medical condition that may prevent the patient from receiving protocol therapy. f. Have history of any psychiatric illness that may prevent the patient from understanding or complying with study requirements. 4. Receiving antitumor therapy other than protocol-specified treatment modalities. 5. Implanted electronic medical devices, such as pacemakers. 6. Known severe hypersensitivity to medical adhesives or hydrogels or to a particular chemotherapeutic agent used in the study. 7. lactational or pregnant women and those with recent birth plans. 8. Participation in other clinical trials within 90 days prior to enrollment screening. 9. those who are not suitable for participation in this clinical trial in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival ;progression-free survival;1-year OS;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactZhenyang Liu
Hunan Cancer Hospital
Outcome results
None listed