Trial Title:
NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study
NCT ID:
NCT06345300
Condition:
Borderline Resectable Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Calcium, Dietary
Leucovorin
Oxaliplatin
Fluorouracil
Irinotecan
Calcium
Levoleucovorin
Conditions: Keywords:
Liposomal Irinotecan
borderline resectable pancreatic cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab
Description:
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.
Arm group label:
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab
Other name:
NALIRIFOX+PD-1
Intervention type:
Drug
Intervention name:
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate
Description:
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.
Arm group label:
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate
Other name:
NALIRIFOX
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
Detailed description:
This study plans to include 40 patients with borderline resectable pancreatic cancer who
are evaluated by a multidisciplinary team (MDT). These patients will receive 3 cycles of
neoadjuvant therapy before surgery. The immunotherapy combination chemotherapy regimen
consists of liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate, and
Camrelizumab, with a 14-day dosing cycle. The chemotherapy regimen consists of liposomal
Irinotecan, Oxaliplatin, and 5-Fluorouracil/Calcium folinate.
Clinical tumor imaging evaluation will be conducted based on the RECIST 1.1 criteria
after the completion of neoadjuvant therapy. The MDT will assess whether patients are
eligible for surgery based on the imaging results. The criteria for operability include:
no evidence of implantation metastasis during laparoscopic exploration, absence of new
metastatic lesions, and the tumor's relationship with blood vessels meeting the criteria
for R0/R1 resection.
Patients eligible for surgery will undergo pancreatic cancer surgery 4-6 weeks later.
Postoperative treatment will be determined by the researchers based on the neoadjuvant
treatment effectiveness and the patients'actual conditions. Imaging evaluations will
follow the standard diagnostic and treatment guidelines for pancreatic cancer.
For patients deemed ineligible for surgery, the subsequent treatment plan will be
determined by the researchers based on the neoadjuvant treatment effectiveness and the
patients' actual conditions
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years, both males and females are eligible.
2. 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°).
3. No prior treatment with local or systemic anti-tumor therapy, including
chemotherapy, radiation therapy, targeted therapy, or immunotherapy.
4. At least one measurable lesion according to Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Expected survival of ≥12 weeks.
7. 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):
1. Absolute neutrophil count (ANC) ≥1.5×10*9/L;
2. Platelets ≥85×10*9/L;
3. Hemoglobin ≥90 g/L;
4. Serum albumin ≥30 g/L;
5. 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);
6. Creatinine clearance > 60 mL/min;
7. 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).
8. 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.
9. Participate in the study and signing of an informed consent form.
Exclusion Criteria:
- Participants who meet any of the following criteria will not be allowed to enter
this study:
1. Pancreatic cancer originating from non-pancreatic ductal epithelium, including
pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatic
embryonal carcinoma, solid pseudo-papillary tumors.
2. Patients with central nervous system metastasis.
3. Severe gastrointestinal dysfunction (with bleeding, inflammation, obstruction,
or diarrhea classified as grade 1 or higher).
4. Existence of grade 3 or 4 peripheral neuropathy.
5. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites
requiring drainage.
6. Uncontrolled systemic infection (viral, bacterial, and fungal).
7. Allergy to previous use of erlotinib liposomes, other liposomal products,
oxaliplatin, 5-fluorouracil, calcium folinate, or any component of the
mentioned products.
8. Allergy to monoclonal antibodies, camrelizumab, or any component of the
investigational drug.
9. Use of any investigational drug within 4 weeks prior to the first use of the
investigational drug in this study.
10. Receipt of the last dose of anticancer therapy (including radiotherapy) within
4 weeks prior to the first use of the investigational drug.
11. Underwent major surgery within 4 weeks prior to the first use of the
investigational drug.
12. Concurrent participation in another clinical study, unless it is an
observational (non-interventional) clinical study or follow-up of an
interventional clinical study.
13. 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.
14. 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).
15. Diagnosed with any other malignant tumor within 5 years prior to the first use
of the investigational drug, excluding malignant tumors with low risk of
metastasis and death (5-year survival rate > 90%), such as adequately treated
basal or squamous cell skin cancer or carcinoma in situ of the cervix.
16. Pregnant or lactating women.
17. Participant judged by the investigator to have other factors that may
necessitate premature termination of the study, such as the presence of other
serious diseases (including mental illnesses) requiring concurrent treatment,
or family or social factors that may affect participant safety or data
collection in the study.
18. Other factors deemed by the investigator to make the participant unsuitable for
participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijin
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongkun Sun
Phone:
13141276041
Email:
hsunyk@126.com
Start date:
March 10, 2024
Completion date:
December 24, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06345300
