Pancreatic AdenocarcinomaPhase 3NCT04835064
Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy.
A Phase 3 study testing Nab paclitaxel, Gemcitabine and mFOLFIRINOX in people with Pancreatic Adenocarcinoma, run by Fudan University.
Trial summary
The main purpose of To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy A secondary purpose To observe relapse-free survival in patients with resectable pancreatic cancer with elevated serum CA125 versus without neoadjuvant… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Nab paclitaxel, Gemcitabine and mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign the informed consent;
- Age ≥18 years old and ≤75 years old, no gender limitation;
- ECOG score ≤1;
- Imaging evaluation of resectable pancreatic cancer, serum CA125≥35 U/mL;
- pancreatic adenocarcinoma confirmed by pathology after pancreatic puncture or surgery;
- No distant metastasis, malignant abdominal effusion or pleural effusion before neoadjuvant chemotherapy;Postoperative baseline chest, abdomen and pelvis CT showed no tumor metastasis/recurrence.
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- Expected survival ≥3 months;
- No serious hematopoietic dysfunction, abnormal functions of heart, lung, liver and kidney and immune deficiency were observed. The laboratory test results met the following criteria: blood routine indicators: white blood cell (WBC) ≥3×109/L;Absolute neutrophils count (ANC) ≥1.5×109/L;Platelet (PLT) ≥100×109/L;Hemoglobin (HGB) ≥9g/dL;Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤2.5× upper limit of normal value (ULN);Total bilirubin (TBil) ≤ULN;Serum creatinine (CRE) ≤1.5×ULN;Coagulation function: Prothrombin time (PT), international standardized ratio (INR) ≤1.5×ULN;
- the willingness of women with potential fertility to use medically approved contraceptives in the trial;
- Able to follow the research visit plan and other program requirements.
Who cannot join
- Patients had received any type of anti-tumor therapy before enrolment, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;
- have central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other uncontrollable serious diseases;
- Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications at baseline;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) cannot be corrected;
- Have a history of other malignant tumor diseases;
- Have a history of allergy to the study drug or similar drug structure;
- Pregnant and lactating women;
- Other reasons why the investigator considers it inappropriate to participate in the clinical study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase III, Multicenter, Prospective, Randomized, Patients With Resectable Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy.
The main purpose of
- To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy A secondary purpose
- To observe relapse-free survival in patients with resectable pancreatic cancer with elevated serum CA125 versus without neoadjuvant chemotherapy
- To observe the resectable rate of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy
- To observe the safety parameters of patients with resectable pancreatic cancer with or without neoadjuvant chemotherapy with elevated serum CA125
Read the detailed description
This study is a prospective, multicenter, randomized, controlled Ⅲ period clinical trials.A total of 600 patients with resectable pancreatic cancer assessed by imaging and serum CA125≥35 U/mL were randomly assigned according to the ratio of 1:1 (300 cases: 300 cases) between the direct surgical resection group and the neoadjuvant chemotherapy group, to observe the efficacy and safety of patients with resectable pancreatic cancer with elevated serum CA125 with or without neoadjuvant chemotherapy.Neoadjuvant chemotherapy and adjuvant chemotherapy can use albumin-binding paclitaxel combined with gemcitabine (AG) regimen or mFOLFirinox (5-FU, calcium leucofolate [LV], irinotecan, oxaliplatin) regimen. AG regimen was given on day 1, 8, 15, and repeated every 4 weeks.The mFOLFIRINOX regimen was administered on days 1 and 15 and repeated every 4 weeks.Patients in the neoadjuvant chemotherapy group were treated with 4 courses of neoadjuvant chemotherapy (AG regimen or mFOLFIRINOX regimen) immediately after the pathologic diagnosis of pancreatic adenocarcinoma was confirmed by puncture.Patients receiving neoadjuvant chemotherapy will undergo surgical exploration to assess the resectability of the tumor.Four to eight weeks after radical resection, the patients were treated with adjuvant chemotherapy from the recovery of surgical trauma. The choice of adjuvant chemotherapy after surgery depended on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy will maintain the original regimen;If neoadjuvant chemotherapy is ineffective but radical surgery is still feasible, adjuvant chemotherapy will be used with a crossover regimen.Neoadjuvant chemotherapy group received adjuvant chemotherapy for 2 courses.In the direct surgical resection group, 6 courses of adjuvant chemotherapy were started 4 to 8 weeks after radical resection.Relevant examinations should be conducted before and after each course of medication to evaluate safety events. Imaging reexaminations should be conducted every 2 courses of medication, and imaging reexaminations should be conducted every 3 months during follow-up to evaluate disease recurrence.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Nab paclitaxel, Gemcitabine, mFOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxelDrug
Also called Abraxane
Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15
GemcitabineDrug
Also called Gemzar
Intravenous infusion of 1000 mg/m2 was given for more than 30min on days 1, 8, and 15, and repeated every 4 weeks
mFOLFIRINOXDrug
Also called modified FOLFIRINOX regimen
Oxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel and Gemcitabine | Experimental | Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15;Gemcitabine 1000 mg/m2 was given intravenously for more than 30min on days 1, 8, and 15, and repeated every 4 weeks. Receives: Drug: Nab paclitaxel; Drug: Gemcitabine |
| mFOLFIRINOX | Experimental | Oxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks. Receives: Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
- To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy
Measured: from randomization to death, up to 36 months
Secondary outcomes (3)
Relapse-free survival
To observe the relapse-free survival of patients with resectable pancreatic cancer with elevated serum CA125 versus without neoadjuvant chemotherapy
Measured: from randomization to recurrence, up to 36 months
Surgical excision rate
- To observe the resectable rate of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy
Measured: from randomization to recurrence, up to 36 months
Incidence of adverse events
- To observe the Incidence of adverse events of patients with resectable pancreatic cancer with or without neoadjuvant chemotherapy with elevated serum CA125
Measured: from randomization to recurrence, 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 posted8 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 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 Jun, M.D., Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835064
- Sponsor's protocol ID
- CSPAC-4
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Prospective, Randomized, Patients With Resectable Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy.
- ClinicalTrials.gov ID
- NCT04835064
- Acronym / sponsor ID
- CSPAC-4
- Conditions
- Pancreatic Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Apr 2021 (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 main purpose of
- To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy A secondary purpose
- To observe relapse-free survival in patients with resectable pancreatic cancer with elevated serum CA125 versus without neoadjuvant chemotherapy
- To observe the resectable rate of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy
- To observe the safety parameters of patients with resectable pancreatic cancer with or without neoadjuvant chemotherapy with elevated serum CA125
Detailed description
This study is a prospective, multicenter, randomized, controlled Ⅲ period clinical trials.A total of 600 patients with resectable pancreatic cancer assessed by imaging and serum CA125≥35 U/mL were randomly assigned according to the ratio of 1:1 (300 cases: 300 cases) between the direct surgical resection group and the neoadjuvant chemotherapy group, to observe the efficacy and safety of patients with resectable pancreatic cancer with elevated serum CA125 with or without neoadjuvant chemotherapy.Neoadjuvant chemotherapy and adjuvant chemotherapy can use albumin-binding paclitaxel combined with gemcitabine (AG) regimen or mFOLFirinox (5-FU, calcium leucofolate [LV], irinotecan, oxaliplatin) regimen. AG regimen was given on day 1, 8, 15, and repeated every 4 weeks.The mFOLFIRINOX regimen was administered on days 1 and 15 and repeated every 4 weeks.Patients in the neoadjuvant chemotherapy group were treated with 4 courses of neoadjuvant chemotherapy (AG regimen or mFOLFIRINOX regimen) immediately after the pathologic diagnosis of pancreatic adenocarcinoma was confirmed by puncture.Patients receiving neoadjuvant chemotherapy will undergo surgical exploration to assess the resectability of the tumor.Four to eight weeks after radical resection, the patients were treated with adjuvant chemotherapy from the recovery of surgical trauma. The choice of adjuvant chemotherapy after surgery depended on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy will maintain the original regimen;If neoadjuvant chemotherapy is ineffective but radical surgery is still feasible, adjuvant chemotherapy will be used with a crossover regimen.Neoadjuvant chemotherapy group received adjuvant chemotherapy for 2 courses.In the direct surgical resection group, 6 courses of adjuvant chemotherapy were started 4 to 8 weeks after radical resection.Relevant examinations should be conducted before and after each course of medication to evaluate safety events. Imaging reexaminations should be conducted every 2 courses of medication, and imaging reexaminations should be conducted every 3 months during follow-up to evaluate disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel and Gemcitabine | Experimental | Drug: Nab paclitaxel, Drug: GemcitabineAlbumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15;Gemcitabine 1000 mg/m2 was given intravenously for more than 30min on days 1, 8, and 15, and repeated every 4 weeks. |
| mFOLFIRINOX | Experimental | Drug: mFOLFIRINOXOxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily participate and sign the informed consent;
- Age ≥18 years old and ≤75 years old, no gender limitation;
- ECOG score ≤1;
- Imaging evaluation of resectable pancreatic cancer, serum CA125≥35 U/mL;
- pancreatic adenocarcinoma confirmed by pathology after pancreatic puncture or surgery;
Key exclusion criteria (7 listed)
- Patients had received any type of anti-tumor therapy before enrolment, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;
- have central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other uncontrollable serious diseases;
- Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications at baseline;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) cannot be corrected;
- Have a history of other malignant tumor diseases;
- Have a history of allergy to the study drug or similar drug structure;
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 paclitaxelAlso: AbraxaneAlbumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15 | Drug | Nab-paclitaxel and Gemcitabine |
| GemcitabineAlso: GemzarIntravenous infusion of 1000 mg/m2 was given for more than 30min on days 1, 8, and 15, and repeated every 4 weeks | Drug | Nab-paclitaxel and Gemcitabine |
| mFOLFIRINOXAlso: modified FOLFIRINOX regimenOxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks. | Drug | mFOLFIRINOX |
Primary outcome
overall survival
Time frame: from randomization to death, up to 36 months
• To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy
3 secondary outcomes
Relapse-free survival
Time frame: from randomization to recurrence, up to 36 months
Surgical excision rate
Time frame: from randomization to recurrence, up to 36 months
Incidence of adverse events
Time frame: from randomization to recurrence, 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 8 Apr 2021.
- Individual participant dataSharing planned: No
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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 Jun, M.D., Ph.D. principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nab paclitaxel, Gemcitabine and mFOLFIRINOX in people with Pancreatic Adenocarcinoma, run by Fudan University.
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 10 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Jun, M.D., Ph.D. (86 21 64175590, xiahuanyu@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 8 Apr 2021.