Pancreatic cancer
Conditions
Interventions
Treatment Group A:Combination of Single-Agent Gemcitabine (S1) Chemotherapy and HIFU Treatment
Treatment Group B:Combination of Arterial Infusion Chemotherapy (AG or GAS Regimen) and HIFU Treatment
Treatment Group C:Combination of Other Anticancer Treatment Regimens with HIFU Treatment
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed pancreatic adenocarcinoma. 2) Age 60 years or over, no restriction of gender. 3) Local advanced stage disease that meets any of the following criteria without distant metastasis: a. For tumors in the pancreatic head and neck: Tumors involving the Superior Mesenteric Artery (SMA) more than 180°. Tumors involving the celiac artery more than 180°. Tumor invasion or occlusion (tumor thrombus or blood clot) leading to unresectable reconstruction of the superior mesenteric vein or portal vein. Tumors extensively involving the distal jejunum drainage branch of the superior mesenteric vein. b. For tumors in the pancreatic body/tail: Tumors involving the superior mesenteric artery or celiac trunk more than 180°. Involvement of both celiac trunk and abdominal aorta. Tumor invasion or occlusion leading to unresectable reconstruction of the superior mesenteric vein or portal vein. Note: Locally recurrent pancreatic cancer may also be included in this study, including recurrences limited to the pancreatic margin, residual pancreas, or mesenteric root. 4) At least one measurable lesion that meets RECIST 1.1 evaluation criteria. 5) Cohorts A and B: Patients with active tumor lesions only in the pancreas, and the tumor size, number ( 1,500/µL, Hemoglobin > 8.0 gm/dL, Platelets > 100,000/µL. Creatinine 30 g/L. 7) Other anti-tumor treatments have been discontinued for at least 2 weeks before HIFU treatment, and adverse reactions have returned to normal or grade 1 (CTCAE 5.0). 8) Patients with bone metastasis are allowed to receive bisphosphonate treatment simultaneously. 9) Patients with jaundice must undergo biliary drainage decompression surgery before enrollment. 10) Able to understand and sign a written informed consent form. 11) Expected survival of at least 3 months. 12) This study is divided into the following treatment groups: Cohort A: Patients with an ECOG performance status score of 3 or who explicitly refuse intravenous/arterial infusion chemotherapy under any circumstances and are willing to receive S-1 monotherapy for local advanced pancreatic cancer. Cohort B: Patients with an ECOG performance status score of 0-2 who are willing to undergo arterial infusion chemotherapy (AG regimen or GAS regimen) for local advanced pancreatic cancer. Cohort C: Local advanced pancreatic cancer patients receiving other anti-tumor treatment regimens, enrolled as an observational cohort.
Exclusion criteria
Exclusion criteria: 1) ECOG performance status score of 4. 2) Central nervous system damage or leptomeningeal disease. 3) Previous systemic therapy or local arterial infusion chemotherapy (consideration may be given if prior treatment was only for 1 cycle or oral targeted or chemotherapy drugs were administered cumulatively for no more than 14 days). 4) More than 50% of bone marrow has received radiation therapy. 5) Other serious diseases or conditions, including congestive heart failure (New York Heart Association class III or IV), unstable angina, history of myocardial infarction within the past 6 months, severe arrhythmias, prolonged QT interval, active HIV infection or AIDS, psychiatric disorders, substance abuse, etc. 6) Known allergies to gemcitabine, paclitaxel, or oxaliplatin. 7) Active infections requiring intravenous antibiotic treatment. 8) Sexually active, fertile males with an untreated partner of childbearing potential and not practicing effective contraception. 9) Known pancreatic neuroendocrine tumor and other non-ductal adenocarcinoma histological types. 10) Past or concurrent cancers originating from primary sites or histologically distinct from pancreatic cancer, excluding in situ cervical cancer, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Enrollment is allowed for any cancer cured for > 5 years prior to inclusion. 11) Inability to swallow capsules or untreated malabsorption syndrome. 12) Non-compliant patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Quality of Life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Disease Control Rate;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactChen Zhen
Fudan University Shanghai Cancer Center
Outcome results
None listed