Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2021-05-09
• Target enrollment: 0
• Participant gender: All

Summary

Exploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with SBRT in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (IC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University Union Hospital
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Age ≥ 18 years old and ≤ 70 years old.

• Histologically or cytologically confirmed adenocarcinoma of the pancreas.

• Borderline resectable or locally advanced pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines

• No prior chemotherapy or radiotherapy

• ECOG performance status of 0 or 1.

• Without distant metastasis

• The maximum diameter of the tumor must not exceed 5 cm

• Acceptable hematology parameters: a. Absolute neutrophil count (ANC) ≥1500 cell/mm3 b. Platelet count ≥100,000/mm3 c. Hemoglobin (Hgb)≥9 g/dL

• Acceptable blood chemistry levels: a. AST/SGOT and ALT/SGPT≤2.5× upper limit of normal range (ULN) b. Total bilirubin≤1.5 ULN c. Alkaline phosphatase≤2.5× ULN d. Serum albumin>3 g/dL e. Serum creatinine≤1.5 ULN

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.

Exclusion Criteria:

• Age < 18 years old and > 70 years old. Prior anticancer therapy for pancreatic carcinoma.

• Presence of or history of metastatic pancreatic adenocarcinoma.

• Patients who had surgeries, chemotherapy, or other treatments before inclusion.

• Any other malignancy within 5 years prior to enrollment

• History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients.

• Peripheral sensory neuropathy Grade > 1

• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders.

• Pregnant or breast feeding.

• Patients enrolled in other clinical trials or incompliant with regular follow-up

• Unwillingness or inability to comply with study procedures.