NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study

NCT06345300 | Unknown Phase 2

• 1 other identifier: NCC4309
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer

Conditions

Borderline Resectable Pancreatic Cancer

Keywords

Liposomal Irinotecan; borderline resectable pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Defined as the proportion of subjects with R0 resection assessed postoperatively

  1 years

Secondary Outcomes (5)

• Event free survival (EFS)

  1.5 years

• Overall survival (OS)

  2 years

• Objective Response Rate(ORR)

  2year

• Disease Control Rate（DCR）

  2 years

• Safety and tolerability by incidence, severity and outcome of adverse events

  2 years

Study Arms (2)

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab

EXPERIMENTAL

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab

Drug: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate

EXPERIMENTAL

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate

Drug: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate

Interventions

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab DRUG

The treatment regimen for this study is as follows: Intravenous infusion of Oxaliplatin at a dose of 85mg/m2 for 2 hours or according to clinical practice at the research center; Intravenous infusion of liposomal Irinotecan at a dose of 60mg/m2 for 90 minutes (±30 min); Intravenous drip of Calcium folinate at a dose of 400mg/m2 for 30 minutes or according to clinical practice at the research center; Intravenous infusion of 5-Fluorouracil at a dose of 2400mg/m2 (infused for 46-48 hours or according to clinical practice at the research center); Camrelizumab at a fixed dose of 200mg, administered via intravenous drip, with each infusion lasting no less than 30 min and no more than 60 min. Administered on day 1 of every 2-week cycle (d1, q2w). Each treatment cycle is 14 days, and all drugs are administered on day 1.

Also known as: NALIRIFOX+PD-1

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate DRUG

The treatment regimen for this study is as follows: Intravenous infusion of Oxaliplatin at a dose of 85mg/m2 for 2 hours or according to clinical practice at the research center; Intravenous infusion of liposomal Irinotecan at a dose of 60mg/m2 for 90 minutes (±30 min); Intravenous drip of Calcium folinate at a dose of 400mg/m2 for 30 minutes or according to clinical practice at the research center; Intravenous infusion of 5-Fluorouracil at a dose of 2400mg/m2 (infused for 46-48 hours or according to clinical practice at the research center); Each treatment cycle is 14 days, and all drugs are administered on day 1.

Also known as: NALIRIFOX

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, both males and females are eligible.
• Histologically or cytologically confirmed pancreatic cancer (originating from pancreatic duct epithelium) assessed by Multidisciplinary Team (MDT) as potentially resectable pancreatic cancer. (According to CSCO guidelines 2022, potentially resectable pancreatic cancer is defined as:Tumor involvement with the portal vein-mesenteric vein \>180° or contact ≤180° with irregular vein contour or vein thrombosis, but can be completely resected and safely reconstructed; tumor involvement with the inferior vena cava;(Tumor involving the pancreatic head/uncinate process) Tumor involvement with the hepatic artery distal to the celiac trunk, with no involvement of the celiac trunk or the origin of the left or right hepatic artery, can be completely resected and safely reconstructed; tumor involvement with the mesenteric artery ≤180°; tumor involvement with variant arteries (such as accessory right hepatic artery, replaced right hepatic artery, replaced common hepatic artery, etc.).(Tumor involving the body and tail of the pancreas) Tumor involvement with the mesenteric artery ≤180°; tumor involvement with the celiac trunk ≤180°).
• No prior treatment with local or systemic anti-tumor therapy, including chemotherapy, radiation therapy, targeted therapy, or immunotherapy.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival of ≥12 weeks.
• Adequate organ function as follows (no use of any blood components, growth factors, leukocyte-boosting agents, platelet-boosting agents, or anemia correction drugs within 14 days prior to the first use of study medication):
• Absolute neutrophil count (ANC) ≥1.5×10\*9/L;
• Platelets ≥85×10\*9/L;
• Hemoglobin ≥90 g/L;
• Serum albumin ≥30 g/L;
• Total bilirubin ≤2.0 × upper limit of normal (ULN) (patients with biliary obstruction after biliary drainage ≤2.5 × ULN), AST and ALT ≤3.0 × ULN (patients with liver metastasis ≤5 × ULN);
• Creatinine clearance \> 60 mL/min;
• Activated partial thromboplastin time (APTT) and International Normalized Ratio (INR) ≤1.5 × ULN (patients taking stable doses of anticoagulants such as low molecular weight heparin or warfarin and INR within the expected therapeutic range of the anticoagulant can be included).
• Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and agree to use appropriate contraception during the observation period and up to 8 weeks after the last administration of the study drug; for males, they must have undergone surgical sterilization or agree to use appropriate contraception during the observation period and up to 12 weeks after the last administration of the study drug.

You may not qualify if:

• Participants who meet any of the following criteria will not be allowed to enter this study:
• Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatic embryonal carcinoma, solid pseudo-papillary tumors.
• Patients with central nervous system metastasis.
• Severe gastrointestinal dysfunction (with bleeding, inflammation, obstruction, or diarrhea classified as grade 1 or higher).
• Existence of grade 3 or 4 peripheral neuropathy.
• Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage.
• Uncontrolled systemic infection (viral, bacterial, and fungal).
• Allergy to previous use of erlotinib liposomes, other liposomal products, oxaliplatin, 5-fluorouracil, calcium folinate, or any component of the mentioned products.
• Allergy to monoclonal antibodies, camrelizumab, or any component of the investigational drug.
• Use of any investigational drug within 4 weeks prior to the first use of the investigational drug in this study.
• Receipt of the last dose of anticancer therapy (including radiotherapy) within 4 weeks prior to the first use of the investigational drug.
• Underwent major surgery within 4 weeks prior to the first use of the investigational drug.
• Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study.
• Participants with poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past year.
• Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) or hepatitis C (positive anti-HCV or HCV-RNA above the detection limit of the assay).

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijin, China

RECRUITING

MeSH Terms

Interventions

irinotecan sucrosofate; Oxaliplatin; Fluorouracil; Leucovorin; camrelizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Yongkun Sun

CONTACT

13141276041; hsunyk@126.com

Yaguang Fan

CONTACT

18515845293; 315700902@qq.com

Study Design

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

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: March 10, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 24, 2025
• Last Updated: April 3, 2024

Record last verified: 2023-12

Locations

CN (1)