NCT05679050

Phase II Study on Sequential AG and FOLFIRINOX as Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Pancreatic cancer is known as the king of cancer and is one of the malignant tumors with a very high mortality rate in the digestive system, which is characterized by a high degree of malignancy and a poor prognosis. The current standard of care is surgical resection followed by adjuvant therapy. However, patients treated with standard surgery had a 2-year median overall survival of approximately 40%. Neoadjuvant therapy can reduce the tumor to a certain extent and downstage the tumor, so as to achieve more R0 resection, reduce the postoperative recurrence rate and prolong survival. SWOG S1505 published by ASCO in 2020 demonstrated adequate safety and high resectability rates for perioperative chemotherapy. The study concluded that perioperative chemotherapy has adequate safety and a high resectability rate. However, neither regimen in this study demonstrated an improvement in OS compared with prior standard therapies. Neoadjuvant treatment of pancreatic cancer therefore remains a long way to go. Recent results from the NEONAX perioperative randomized phase II study for pancreatic cancer presented at the ASCO meeting in 2022 confirmed the benefit of neoadjuvant therapy and demonstrated the OS benefit brought about by neoadjuvant therapy. Neoadjuvant regimens require regimens with good tumor shrinkage and high response rate, and there is no standard regimen for neoadjuvant therapy of pancreatic cancer, often referring to regimens with high response rate for advanced treatment. However, due to the high malignancy and disease particularity of pancreatic cancer, there is no advanced treatment regimen with high response rate. The mFOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin) and AG regimens (gemcitabine combined with nab-paclitaxel) are commonly used regimens in clinical practice. Therapeutic options for pancreatic cancer are limited, therefore, different combinations and application sequences of existing regimens are one of the directions explored in clinical research. In summary, 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 study exploration, 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

Type	Name	Description
DRUG	AG Followed by FOLFIRINOX	AG（every 28 days) Nab-paclitaxel 125 mg/m2 i.v. over 30 min, gemcitabine hydrochloride 1g/m2 i.v. over 30 min, D1, 8 and 15 ; FOLFIRINOX(every 42 days) Oxaliplatin: 65 mg/m2 i.v. over 2h on D1, 15, 29; Tetrahydrofolate: 400 mg/m2 i.v.2h on D1, 15, 29; Irinotecan: 150 mg/m2 i.v. over 90 min every 42 days on D1, 15, 29; 5-FU: 2400 mg/m2 i.v. over 46h /14 days on D1-3, 15-17, and 29-31; After one round of above therapy, patients achieving stable disease and above without disease progression or unacceptable toxicity underwent pancreatectomy within 4-8 weeks; Patients who did not achieve stable disease and above were treated another round , and patients who achieved stable disease and above underwent pancreatectomy at 4-8 weeks. Following pancreatectomy, patients underwent AG regimen (2 rounds, 56 days) followed by FOLFIRINOX regimen (42 days) in the absence of disease progression or unacceptable toxicity, and AG and FOLFIRINOX dosing as the preoperative therapy.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2023-01-10
• Last updated: 2023-01-10

Locations

1 site across 1 country: China