Borderline Resectable Pancreatic CancerPhase 2NCT06345300
NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study
A Phase 2 study testing Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab and Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in people with Borderline Resectable Pancreatic Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Resectable Pancreatic Cancer
- What is being tested?
- Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab and Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2024to 24 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Participate in the study and signing of an informed consent form.
Who cannot join
- 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.
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- 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).
- 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.
- Pregnant or lactating women.
- 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.
- Other factors deemed by the investigator to make the participant unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijin
Yongkun Sun, 13141276041, hsunyk@126.com
About this study
Official title: Liposomal Irinotecan，Oxaliplatin, 5-Fluorouracil/Calcium Folinate in Combination With Camrelizumab for Borderline Resectable Pancreatic Cancer: a Prospective, Exploratory Study
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
Read the 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
- Conditions
- Borderline Resectable Pancreatic Cancer
- Being tested
- Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab, Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate
- Keywords
- Liposomal Irinotecan, borderline resectable pancreatic cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with CamrelizumabDrug
Also called NALIRIFOX+PD-1
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.
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinateDrug
Also called NALIRIFOX
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.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab | Experimental | Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab Receives: 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 Receives: Drug: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Defined as the proportion of subjects with R0 resection assessed postoperatively
Measured: 1 years
Secondary outcomes (5)
Event free survival (EFS)
The time from randomization to the occurrence of any of the following events, whichever comes first:
Radiographic tumor progression evaluated according to RECIST 1.1 criteria. Tumor recurrence assessed by imaging, including local recurrence or distant metastasis.
Death due to any cause.
Measured: 1.5 years
Overall survival (OS)
The time from the initiation of the first dose of medication in a patient to death from any cause.
Measured: 2 years
Objective Response Rate(ORR)
The proportion of patients with a confirmed complete response or partial response using RECIST 1.1
Measured: 2year
Disease Control Rate（DCR）
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
Measured: 2 years
Safety and tolerability by incidence, severity and outcome of adverse events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start10 Mar 2024
- Primary completion12 Dec 2024 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345300
- Sponsor's protocol ID
- NCC4309
- Status last verified
- Dec 2023
- First submitted
- 28 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Irinotecan，Oxaliplatin, 5-Fluorouracil/Calcium Folinate in Combination With Camrelizumab for Borderline Resectable Pancreatic Cancer: a Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT06345300
- Acronym / sponsor ID
- NCC4309
- Conditions
- Borderline Resectable Pancreatic Cancer
- Keywords
- Liposomal Irinotecan, borderline resectable pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab | Experimental | Drug: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with CamrelizumabLiposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab |
| Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate | Experimental | Drug: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinateLiposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (19 listed)
- Participants who meet any of the following criteria will not be allowed to enter this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with CamrelizumabAlso: NALIRIFOX+PD-1The 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. | Drug | Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab |
| Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinateAlso: NALIRIFOXThe 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. | Drug | Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate |
Primary outcome
R0 resection rate
Time frame: 1 years
Defined as the proportion of subjects with R0 resection assessed postoperatively
5 secondary outcomes
Event free survival (EFS)
Time frame: 1.5 years
Overall survival (OS)
Time frame: 2 years
Objective Response Rate(ORR)
Time frame: 2year
Disease Control Rate（DCR）
Time frame: 2 years
Safety and tolerability by incidence, severity and outcome of adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab and Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in people with Borderline Resectable Pancreatic Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongkun Sun (13141276041, hsunyk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.