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

NCT05679050 | Unknown Phase 2

• 1 other identifier: TJGI-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• R0 Resection Rate

  Percentage of patients who achieved R0 resection

  Within 4-8 weeks of last dose of pre-operative chemotherapy

• Disease-free Survival(DFS)

  Duration of patients alive without recurrence of disease

  4 years

Secondary Outcomes (5)

• Operation Rate

  Within 4-8 weeks of last dose of pre-operative chemotherapy

• Objective Response Rate

  Within 4-8 weeks of last dose of pre-operative chemotherapy

• 2-year Overall Survival Rate

  from treatment initiation until death due to any cause, assessed up to 2 year

• Local or distant recurrence after R0 or R1 resection Rates

  4 years

• Treatment-Emergent Adverse Event Rate

  1 year

Study Arms (1)

AG Regimen Followed by FOLFIRINOX Regimen

EXPERIMENTAL

AG Regimen Followed by FOLFIRINOX Regimen

Drug: AG Followed by FOLFIRINOX

Interventions

AG Followed by FOLFIRINOX DRUG

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.

AG Regimen Followed by FOLFIRINOX Regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed pancreatic cancer.
• ECOG performance status must be 0-1.
• years
• 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.
• 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.
• Patients must receive surgical consultation within 21 days before registration to verify whether the patient is eligible for surgery;
• Patients must have normal hematological function within 14 days before registration, including: ANC \> 1,500/mcL; platelets \> 100,000/mcL; hemoglobin \> 9 g/dL.
• 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.
• Patients must have normal renal function as indicated by serum creatinine ≤ 1 ULN within 14 days prior to enrollment.

You may not qualify if:

• Previous surgery, radiotherapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer.
• Histology other than adenocarcinoma or any mixed histological features.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Rui Liu

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Central Study Contacts

Rui Liu

CONTACT

13602139003; liurui9003@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: January 10, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: January 10, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)