NALIRIFOX as Induction Therapy in LAPC

NCT06467565 | Recruiting Phase 2

• 1 other identifier: 2023-SR-254
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.

  Up to 1 year

Secondary Outcomes (3)

• Progression free survival (PFS)

  Up to two years

• Overall survival (OS)

  Up to two years

• Adverse events (safety)

  Up to two years

Study Arms (1)

NALIRIFOX

EXPERIMENTAL

NALIRIFOX（Oxaliplatin 60 mg/m2 IV over 2 hours ; Liposomal Irinotecan 50 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion） on days 1 of a 14-day cycle.

Drug: Liposomal irinotecan

Interventions

Liposomal irinotecan DRUG

NALIRIFOX（Oxaliplatin 60 mg/m2 IV over 2 hours ; Liposomal Irinotecan 50 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion） on days 1 of a 14-day cycle.

NALIRIFOX

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, ≤ 70 years old, male or female;
• Understand the objectives and benefits and risks of the clinical trial, voluntarily participate in and sign the informed consent form;
• ECOG score 0-1;
• The subject had histopathologically or cytologically confirmed type of pancreatic ductal adenocarcinoma
• Local progression according to the 2022 CSCO guidelines;
• Initial subjects with locally advanced pancreatic cancer who have not undergone resection of pancreatic tumor (except open exploration or internal drainage surgery), chemotherapy, targeted, or immunotherapy.
• At least one measurable pancreatic lesion per RECIST 1.1 criteria;
• Expected survival time ≥ 3 months.
• Heart, lung, liver, kidney and other major organ functions are basically normal.
• Hematology tests should meet the following criteria (no blood transfusion, no use of blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to hematology):
• White blood cell count ≥ 3.0 × 109/L and neutrophil count ≥ 1.5 × 109/L.
• Platelet count ≥ 100 × 109/L.
• Hemoglobin ≥ 90 g/L.
• If component blood transfusions (red blood cells, platelets, etc.) are received at screening, reexamination of hematology must be performed at 1-week intervals before further screening can be considered.
• Blood chemistry tests should meet the following criteria:

You may not qualify if:

• Known allergy or intolerance to the ingredients or excipients of this investigational product.
• Any metastatic lesions.
• Patients with unresolved acute or chronic infection
• Other malignancies within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• Active hepatitis.
• Patients with portal hypertension or cavernous transformation of the portal vein; patients with gastrointestinal bleeding caused by tumor involving the digestive tract; patients with intra-abdominal fistula or abscess due to tumor involvement of digestive tract; the tumor encircles the celiac trunk or SMA and causes significant vascular wall involvement (worm-like changes);
• Presence of third space effusion that cannot be controlled by drainage or other means (e.g., moderate-large pleural effusion, moderate-large pericardial effusion, ascites); a small amount of pleural effusion or ascites that is not clinically symptomatic and does not require clinical intervention should be strictly controlled before enrollment.
• Mental illness or mental disorder, poor compliance, unable to cooperate with treatment
• Patients with severe organic diseases or major organ failure, such as decompensated heart and lung failure, which lead to intolerance to chemotherapy.
• Abnormal coagulation (INR \> 1.5, APTT \> 1.5 ULN), bleeding tendency (e.g., active ulcer lesions in the stomach, occult blood in stool (+ +), melena and/or hematemesis within 3 months, hemoptysis) or near the location of the lesion to major vessels.
• Patients with Grade I or higher coronary heart disease, arrhythmia (including QTc prolongation \> 450 ms in males and \> 470 ms in females), taking arrhythmic drugs, or associated underlying heart disease and cardiac insufficiency.
• Patients with renal insufficiency, previous renal disease, and positive urine protein (urine protein test 2 + or more, or 24-hour urineprotein quantitation \> 1.0 g).
• Organ transplant recipients.
• There are drug addicts and other adverse drug addicts, long-term alcoholics and AIDS and other infectious diseases.
• Long-term use of corticosteroids or immunosuppressants.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 025, China

RECRUITING

MeSH Terms

Interventions

irinotecan sucrosofate

Central Study Contacts

Rong K Jiang, MD

CONTACT

+8615312995688; jiangkuirong@njmu.edu.cn

Min Tu, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 21, 2024
• Study Start: December 25, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)