Neoadjuvant therapy for resectable pancreatic cancer using AG and FOLFIRINOX

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

This study is testing a new treatment plan for people with operable pancreatic cancer to see if a combination of two therapies can help shrink tumors and improve survival rates.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT05679050 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of a sequential neoadjuvant therapy approach using the AG regimen followed by FOLFIRINOX in patients with resectable pancreatic cancer. The aim is to assess how this treatment impacts tumor shrinkage, resectability, and overall survival rates. By evaluating health-related quality of life, the study seeks to provide new treatment options for patients facing this aggressive cancer. The research builds on previous findings that suggest neoadjuvant therapy can improve surgical outcomes and reduce recurrence rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed resectable pancreatic cancer and an ECOG performance status of 0-1.

Not a fit: Patients with unresectable pancreatic cancer or those with significant comorbidities affecting their ability to undergo treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and longer survival for patients with resectable pancreatic cancer.

How similar studies have performed: Previous studies have shown promise for neoadjuvant therapies in pancreatic cancer, indicating potential benefits, though this specific regimen is being explored further.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin

• Rui Liu — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Rui Liu

Conditions Resectable Pancreatic Cancer