Borderline Resectable Pancreatic CancerPhase 3NCT04617821
AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic Cancer
A Phase 3 study testing Nab paclitaxel plus gemcitabine and mFOLFIRINOX in people with Borderline Resectable Pancreatic Cancer and Locally Advanced Pancreatic Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, single-center, randomized, controlled phase Ⅲ study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Borderline Resectable Pancreatic Cancer, Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Nab paclitaxel plus gemcitabine and mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to Sep 2024
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed content obtained prior to treatment
- Age ≥18 years and ≤ 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Radiographically confirmed after borderline resectable or locally advanced pancreatic adenocarcinoma.
- No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
- No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
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- No serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards)
- White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb)≥ 9 g/dL
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
- Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 ×ULN
- Comply with research visit plans and other program requirements.
Who cannot join
- with other systemic malignancies
- Patients who were treated with any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
- used any other study drug within 7 days prior to enrollment;
- Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled
- History of allergic reactions attributed to compounds of similar chemical or biological composition to study drug and alike.
- Patients who are using and expected to use warfarin in long term
- Patients may leave the observation for 14 days or more during the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
XianJun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
Xianjun Yu, M.D., Ph.D.
About this study
Official title: A Phase Ⅲ, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine Versus mFOLFIRINOX in Treating Patients With Borderline Reseactable and Locally Advanced Pancreatic Cancer
This is a prospective, single-center, randomized, controlled phase Ⅲ study.
Read the detailed description
Three hundred patients with borderline resectable and locally advanced pancreatic cancer will be randomized 1:1 (150 :150) to the AG and mFOLFIRINOX chemotherapy groups and to observe the overall survival.
The AG regimen: albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles.
MFOLFIRINOX: Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.
After neoadjuvant chemotherapy, the surgery will be evaluated according to the patient's tumor and systemic condition.
The first cycle of adjuvant chemotherapy begins 4-8 weeks after radical resection, and the choice of adjuvant chemotherapy regimen depends on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy maintains the original regimen.Adjuvant chemotherapy has 4 cycles of treatment.
Relevant examinations were performed before and after each cycle of medication to assess safety events, imaging review was performed every 2 cycles during the treatment period and every 3 months during the follow-up period.
- Being tested
- Nab paclitaxel plus gemcitabine, mFOLFIRINOX
- Keywords
- neoadjuvant chemotherapy, albumin bound paclitaxel, mFOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxel plus gemcitabineDrug
Also called AG regimen
Albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycle.
mFOLFIRINOXDrug
Also called modified FOLFIRINOX regimen
Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| albumin bound paclitaxel plus gemcitabine | Experimental | Albumin-bound paclitaxel and gemcitabine were given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles. Receives: Drug: Nab paclitaxel plus gemcitabine |
| mFOFLIRINOX | Active comparator | Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles. Receives: Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
To evaluate the overall survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy
Measured: from randomization to death, up to 36 months
Secondary outcomes (5)
recurrence free survival
To evaluate the recurrence free survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy
Measured: from randomization to recurrence, up to 36 months
objective response rate
To evaluate the objective response rate of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy
Measured: up to 36 months
resection rate
The proportion of patients who become operable from inoperable after neoadjuvant chemotherapy.
Measured: up to 36 months
R0 resection
The proportion of R0 resection among patients who undergo operations.
Measured: up to 36 months
postoperative complications
The incidence of postoperative complications
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Sep 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (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 Fudan UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three hundred patients with borderline resectable and locally advanced pancreatic cancer are randomized 1:1 to the AG and mFOLFIRINOX chemotherapy groups and to observe the total survival.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xian-Jun Yu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617821
- Sponsor's protocol ID
- CSPAC-28
- Status last verified
- Jan 2022
- First submitted
- 2 Nov 2020
- Last updated
- 28 Jan 2022
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine Versus mFOLFIRINOX in Treating Patients With Borderline Reseactable and Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04617821
- Acronym / sponsor ID
- CSPAC-28
- Keywords
- neoadjuvant chemotherapy, albumin bound paclitaxel, mFOLFIRINOX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Nov 2020 (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.
This is a prospective, single-center, randomized, controlled phase Ⅲ study.
Detailed description
Three hundred patients with borderline resectable and locally advanced pancreatic cancer will be randomized 1:1 (150 :150) to the AG and mFOLFIRINOX chemotherapy groups and to observe the overall survival.
The AG regimen: albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles.
MFOLFIRINOX: Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.
After neoadjuvant chemotherapy, the surgery will be evaluated according to the patient's tumor and systemic condition.
The first cycle of adjuvant chemotherapy begins 4-8 weeks after radical resection, and the choice of adjuvant chemotherapy regimen depends on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy maintains the original regimen.Adjuvant chemotherapy has 4 cycles of treatment.
Relevant examinations were performed before and after each cycle of medication to assess safety events, imaging review was performed every 2 cycles during the treatment period and every 3 months during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Three hundred patients with borderline resectable and locally advanced pancreatic cancer are randomized 1:1 to the AG and mFOLFIRINOX chemotherapy groups and to observe the total survival.
| Arm | Type | Receives |
|---|---|---|
| albumin bound paclitaxel plus gemcitabine | Experimental | Drug: Nab paclitaxel plus gemcitabineAlbumin-bound paclitaxel and gemcitabine were given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles. |
| mFOFLIRINOX | Active comparator | Drug: mFOLFIRINOXIntravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed content obtained prior to treatment
- Age ≥18 years and ≤ 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Radiographically confirmed after borderline resectable or locally advanced pancreatic adenocarcinoma.
- No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
Key exclusion criteria (7 listed)
- with other systemic malignancies
- Patients who were treated with any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
- used any other study drug within 7 days prior to enrollment;
- Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled
- History of allergic reactions attributed to compounds of similar chemical or biological composition to study drug and alike.
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 |
|---|---|---|
| Nab paclitaxel plus gemcitabineAlso: AG regimenAlbumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycle. | Drug | albumin bound paclitaxel plus gemcitabine |
| mFOLFIRINOXAlso: modified FOLFIRINOX regimenIntravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles. | Drug | mFOFLIRINOX |
Primary outcome
overall survival
Time frame: from randomization to death, up to 36 months
To evaluate the overall survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy
5 secondary outcomes
recurrence free survival
Time frame: from randomization to recurrence, up to 36 months
objective response rate
Time frame: up to 36 months
resection rate
Time frame: up to 36 months
R0 resection
Time frame: up to 36 months
postoperative complications
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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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.
Xian-Jun Yu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nab paclitaxel plus gemcitabine and mFOLFIRINOX in people with Borderline Resectable Pancreatic Cancer and Locally Advanced Pancreatic Adenocarcinoma, run by Fudan University 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 11 inclusion and 7 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 28 Jan 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xian-Jun Yu, MD, PhD (+86 21 64175590, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: from randomization to death, up to 36 months). 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 28 Jan 2022.