mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy

Phase 2

Recruiting

• Conditions: Pancreatic Cancer; Radiotherapy
• Interventions: Drug: mFOLFIRINOX plus IMRT

• Registration Number: NCT06249321
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer refractory to chemotherapy.

Detailed Description

Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity.

Carbohydrate antigen 19-9 (CA19-9) is the most widely used biomarker in pancreatic cancer. Circulating CA19-9 levels are positively correlated with tumor burden and stage in pancreatic cancer with a diagnostic sensitivity of approximately 80%, suggesting that approximately 20% of patients have normal CA19-9 levels. It is well recognized that Lewis (-) individuals, constituting approximately 10% of the population, have low or no secretion of CA19-9 due to the lack of critical enzyme involved in CA19-9 biosynthesis. Thus, approximately 10% of patients with pancreatic cancer have normal CA19-9 levels regardless of tumor stage. Our previously retrospective study has shown that CA19-9-normal advanced pancreatic cancer may be more sensitive to chemotherapy combined with radiotherapy.

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to patients with CA19-9-normal advanced pancreatic cancer who are refractory to chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every four weeks.

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-08
• Status Verified: 2024-03
• Study Start: 2024-04-01
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2026-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Ability to understand and the willingness to sign a written informed consent document.
• Age ≥ 18 years and ≤ 80 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
• Patients who are refractory to at least one line of chemotherapy and who have not received radiotherapy.
• Locally advanced or distant metastatic pancreatic cancer.
• Baseline serum CA19-9 ≤ 37 U/mL, CEA≤ 5.2 ng/mL, and CA125 ≤ 35 U/mL.
• Presence of at least of one measurable lesion in agreement to RECIST criteria.
• The expected survival ≥ 3 months.
• Adequate organ performance based on laboratory blood tests.
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria

• Pregnant or nursing women.
• Primary pancreatic cancer.
• Baseline serum CA19-9 > 37 U/mL, CEA > 5.2 ng/mL, or CA125 > 35 U/mL.
• The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
• Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
• Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
• Renal insufficiency or dialysis
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
• Patients who are allergic to oxaplatin or other chemotherapy drugs.
• Patients who are unwilling or unable to comply with study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mFOLFIRINOX plus radiotherapy	mFOLFIRINOX plus IMRT	Patients with advanced pancreatic adenocarcinoma will receive the modified FOLFIRINOX regimen (oxaliplatin \[70 mg per square meter of body surface area\], irinotecan \[130 mg per square meter\], leucovorin \[200 mg per square meter\], and fluorouracil \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy.

Primary Outcome Measures

Name	Time	Method
progression-free survival, PFS	At the end of Cycle 1 (each cycle is 28 days)	PFS of subjects from recruiting to the time of disease progression

Secondary Outcome Measures

Name	Time	Method
objective response rate (ORR)	At the end of Cycle 1 (each cycle is 28 days)	CR + PR
Overall survival，OS	At the end of Cycle 1 (each cycle is 28 days)	OS of subjects from recruiting to the time of death from any cause
disease control rate (DCR)	At the end of Cycle 1 (each cycle is 28 days)	CR + PR + SD

Trial Locations

Locations (1)

Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China