Single-arm, Single-centered, Open-label Phase II Study on Sequential AG Regimen and FOLFIRINOX Regimen as Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer

Trial ID: NCT05679050

Interventional - Phase 2 - Unknown status

Based on the safety and benefit of neoadjuvant therapy for patients with pancreatic cancer in the available evidence, as well as the principle of sequential chemotherapy with different regimens and the existing preliminary investigation , the aim of this study was to further explore the efficacy and safety of neoadjuvant therapy with AG regimen followed by FOLFIRINOX regimen in patients with resectable pancreatic cancer, and to assess the impact of neoadjuvant therapy on the health-related quality of life of patients, in order to bring new treatment options for neoadjuvant therapy of pancreatic cancer.

Conditions

• Resectable Pancreatic Cancer

Interventions

• AG Followed by FOLFIRINOX

Eligibility

Inclusion criteria

• 1. Patients must have histologically or cytologically confirmed pancreatic cancer.
• 2. ECOG performance status must be 0-1.
• 3. 18-75 years
• 4. patients must have measurable pancreatic disease. CT scans or MRIs to assess measurable disease must have been completed within 28 days prior to enrollment. All disease must be assessed and documented on the Baseline Tumor Assessment form.
• 5. Patients must have a primary tumor resectable on contrast-enhanced CT or MRI of the chest, abdomen, and pelvis, which is defined as: (1) no involvement of the celiac artery, common hepatic artery, and superior mesenteric artery. (2) The portal vein and/or superior mesenteric vein were not involved, or the interface between the tumor and the vessel wall was \< 180 °; the portal vein/splenic vein confluence was patent. (3) No evidence of metastatic disease. Lymphadenopathy outside the operative pelvis (defined as lymph nodes with a short axis \> 1 cm) (ie, para-aortic, pericaval, celiac trunk, or distal lymph nodes) was considered M1 disease, rendering the patient ineligible. However, if these lymph nodes are biopsied and negative, enrollment may be considered following review by the study chair. Note: For pancreatic body and tail tumors, any degree of splenic arteriovenous involvement is considered resectable.
• 6. Patients must receive surgical consultation within 21 days before registration to verify whether the patient is eligible for surgery;
• 7. Patients must have normal hematological function within 14 days before registration, including: ANC \> 1,500/mcL; platelets \> 100,000/mcL; hemoglobin \> 9 g/dL.
• 8. Patients must have normal liver function within 14 days prior to enrollment as evidenced by: total bilirubin \< 1.5 × upper limit of normal (1ULN); AST and ALT \< 3 × 1ULN; serum albumin \> 3 g/dL.
• 9. Patients must have normal renal function as indicated by serum creatinine ≤ 1 ULN within 14 days prior to enrollment.

Exclusion criteria

• 1. Previous surgery, radiotherapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer.
• 2. Histology other than adenocarcinoma or any mixed histological features.
• 3. Patients with uncontrolled concurrent medical conditions including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements were excluded.
• 4. No prior malignancy is allowed except for adequately treated basal (or squamous) skin cancer, in situ cervical cancer, in situ breast cancer (ductal or lobular). Tumors were eligible if they were eradicated and had no evidence of disease for more than 3 years.
• 5. Patients must not be pregnant or breastfeeding because there is a risk of harm to the fetus or nursing infant. Females/males of childbearing potential must agree to use an effective method of contraception for 3 months following the last dose of chemotherapy.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Source: ClinicalTrials.gov

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