Advanced Pancreatic Cancer (Part 1)Phase 1/2NCT06782685
Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV
A Phase 1/2 study testing Irinotecan liposoma, oxaliplatin and bevacizumab in people with Advanced Pancreatic Cancer (Part 1), run by Dai, Guanghai at 2 sites in China.
Trial summary
Purpose of the study Phase I study: to explore the optimal dose combination of irinotecan liposome + oxaliplatin + bevacizumab regimen, irinotecan liposome + oxaliplatin Phase II study: to evaluate the safety and efficacy of the second-line treatment regimen of irinotecan liposome combined with oxaliplatin and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Cancer (Part 1)
- What is being tested?
- Irinotecan liposoma, oxaliplatin and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesChina
- Study dates
- 23 Jun 2024to Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age 18 to 75 years old;
- Patients with pancreatic cancer diagnosed by histopathology or cytology;
- Unresectable disease assessed by multidisciplinary and imaging;
- Subjects who have received prior failed first-line therapy, and recurrence within 6 months of the end of (neo)adjuvant therapy is considered a first-line treatment failure;
- Subjects who have not received platinum-containing or irinotecan drugs for prior first-line therapy;
- Patients with at least one evaluable lesion according to RECIST v1.1;
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- ECOG score of 0-2;
- Expected survival ≥ 3 months;
- Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, hemoglobin ≥90 g/dL, platelets (PLT) ≥100×10^9/L, and white blood cells (WBC) ≥3.0×10^9/L;
- Liver function: alanine aminotransferase (ALT), alanine aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), or ≤5×ULN if liver metastases are present, total bilirubin<1.5 ULN;
- Renal function: serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min (according to the Cockcroft-Gault formula);
- Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5 × ULN;
- Patients with biliary obstruction should receive adequate biliary drainage; and
- Adverse reactions arising from prior therapy must be restored to grade 1 or baseline according to CTCAE 5.0 (with the exception of toxicities such as alopecia, grade 2 or lower peripheral neuropathy, which can be enrolled with no safety risk in the judgment of the investigator);
- Non-pregnant or lactating females; females/males of childbearing potential should use effective contraception during the study and for 6 months after completion of study treatment;
- Patients are compliant, understand the study procedures, and sign a written informed consent form.
Who cannot join
- Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and basal cell carcinoma of the skin);
- Uncontrollable pleural effusion or ascites;
- Any known brain metastasis or meningeal metastasis;
- Concomitant use of a potent CYP3A4 inducer within 3 weeks prior to the first dose, or concurrent use of a potent CYP3A4 inhibitor or potent UGT1A1 inhibitor within 3 weeks prior to the first dose;
- Patients undergoing major organ surgery (except needle biopsy, central venous catheterization, port catheterization, stent placement for relief of biliary obstruction, percutaneous hepato-biliary drainage, cholecystostomy) or elective surgical procedures scheduled within 4 weeks prior to the first dose of study drug;
- Systemically treated active, uncontrolled bacterial, viral, or fungal infections, defined as persistent signs/symptoms associated with the infection that do not improve despite appropriate antibiotics, antiviral therapy, and/or other treatments;
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- Subjects with congenital or acquired immunodeficiency, such as HIV-infected individuals or active hepatitis (transaminases do not meet the inclusion criteria, Hepatitis B : HBV DNA ≥ 1000 IU/ml; Hepatitis C : HCV RNA ≥ 1000 IU/ml); chronic hepatitis B viral carriers, with HBV DNA < 2000 IU/ml, who must be concurrently receiving antiviral during the trial period treatment before enrollment;
- Presence of serious concomitant diseases: those with diabetes mellitus that cannot be well controlled by glucose-lowering drugs, difficult-to-control hypertension, severe cardiovascular and cerebral vascular disease, renal failure, hepatic failure, uncontrolled epilepsy, central nervous system disease or history of mental disorders, those with a clear tendency to gastrointestinal bleeding, intestinal paralysis, intestinal obstruction, etc;
- >grade 1 diarrhea with an increase in the number of bowel movements >4 times per day compared to baseline; moderate to severe increase in stoma discharge; limited instrumental activities of daily living or even limited spontaneous activities of daily living; life-threatening; requiring urgent treatment;
- Those with serum albumin ≤ 3 g/dL;
- Those who had participated in other clinical studies within 4 weeks prior to enrollment;
- Patients assessed by the investigator to be unsuitable for participation in the trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing
Beijing
- Recruiting
Chinese PLA General Hospital
Beijing
Guanghai Dai, 13801232381, daigh60@sohu.com
About this study
Official title: Liposomal Irinotecan in Combination With Oxaliplatin and Bevacizumab Versus Liposomal Irinotecan in Combination With 5-FU/LV for the Second-line Treatment of Advanced Pancreatic Cancer
Purpose of the study Phase I study: to explore the optimal dose combination of irinotecan liposome + oxaliplatin + bevacizumab regimen, irinotecan liposome + oxaliplatin Phase II study: to evaluate the safety and efficacy of the second-line treatment regimen of irinotecan liposome combined with oxaliplatin and bevacizumab compared to the second-line treatment regimen of irinotecan liposome combined with 5-FU/LV in advanced pancreatic cancer Sample size 138 cases Phase I Crawl, sample size 9-18 cases. Phase II randomized controlled clinical study, historical data NAPOLI-1 study, ORR of 8.8% for irinotecan liposome + 5-FU/LV, planned trial arm ORR upgrade to 25%, calculated at 60 cases in each arm.
Subject population Patients with advanced pancreatic cancer diagnosed after failure of first-line therapy, confirmed by histopathology or cytopathology, who meet the inclusion criteria and do not meet the exclusion criteria.
Read more
Phase I design:
Liposomal irinotecan + oxaliplatin + bevacizumab, 2-week regimen Liposomal irinotecan: start exploring with 50mg/m2 dose, preset 50mg/m2, 60mg/m2, 2 dose groups, 90min IV infusion, d1; Oxaliplatin: explored from 60mg/m2 dose, preset 60mg/m2, 85mg/m2, 2 dose groups, IV infusion, d1; Bevacizumab: 5 mg/kg, i.v., d1; Phase II study design.
Trial group:
Irinotecan liposomal: RP2D, i.v., 90min, d1; Oxaliplatin: RP2D, i.v., d1; Bevacizumab: 5mg/kg, i.v., d1; Cycles every 2 weeks until disease progression or intolerable; imaging every 3 treatment cycles/1.5 months.
Control:
Liposomal irinotecan: 70 mg/m2 IV for 90 min, d1; Calcium folinate: 400 mg/m2, IV infusion over 30 min, d1; 5-FU: 2400 mg/m2, continuous IV infusion over 46h; Cycles every 2 weeks until disease progression or intolerable; imaging every 3 treatment cycles/1.5 months.
Notes:
If the duration of irinotecan liposome infusion can be extended appropriately based on the patient\'s clinical response; if the patient withdraws from the trial due to intolerance of toxicity (e.g., neurotoxicity or myelotoxicity) induced by one of the drugs, follow up is required until PFS and OS.
Translated with DeepL.com (free version)
- Conditions
- Advanced Pancreatic Cancer (Part 1)
- Being tested
- Irinotecan liposoma, oxaliplatin, bevacizumab, 5-FU, LV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposomaDrug
Exploration started with 50mg/m^2 dose, preset 50mg/m^2, 60mg/m^2, 2 dose groups, IV infusion 90min, d1
oxaliplatinDrug
Exploration started with 60mg/m^2 dose, preset 60mg/m^2, 85mg/m^2, 2 dose groups, IV infusion, d1
bevacizumabDrug
5mg/kg，i.v.，d1
5-FUDrug
2400mg/m^2, i.v.，46h
LVDrug
400mg/m^2, i.v.，d1
Irinotecan LiposomalDrug
70mg/m^2, i.v.，d1
Irinotecan LiposomalDrug
Phase II recommended dose
OxaliplatinDrug
Phase II recommended dose
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposomal combination of oxaliplatin and bevacizumab | Experimental | To explore the optimal dose combination of irinotecan liposomes plus oxaliplatin in the regimen of irinotecan liposomes plus oxaliplatin in bevacizumab and determine the recommended dose for phase II Receives: Drug: Irinotecan liposoma; Drug: oxaliplatin; Drug: bevacizumab |
| Irinotecan liposomal combination of 5-FU/LV | Active comparator | Standard treatment Receives: Drug: 5-FU; Drug: LV; Drug: Irinotecan Liposomal |
| Irinotecan liposomal +oxaliplatin +bevacizumab | Experimental | Phase II recommended dose Receives: Drug: bevacizumab; Drug: Irinotecan Liposomal; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the optimal dose combination of irinotecan liposomes plus oxaliplatin in the regimen of irinotecan liposomes plus oxaliplatin in bevacizumab
The DLT determination criteria are as follows:
- Hematologic toxicity：
- Grade 4 neutropenia with application of granulocyte colony-stimulating factor still persisting for >3 days ;
- Grade 3 or above FN;
- Grade 3 thrombocytopenia with bleeding and/or need for blood transfusion;
- Grade 4 thrombocytopenia;
- Grade 4 anemia.
- Non-hematologic toxicity： ≥ Grade 3 non-hematologic toxicity, except: ① Transient (≤24 hours) Grade 3 fever (>40°C), Grade 3 malaise, Grade 3 headache, Grade 3 nausea, which recovers to Grade 1 or baseline after treatment; Grade 3 vomiting, Grade 3 electrolyte disorders (including hypokalemia, hypophosphatemia, hypocalcemia, etc.), recovery to Grade 1 or baseline within 48 hours after treatment.
Measured: At the end of Cycle 1 (each cycle is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start23 Jun 2024
- Primary completionJul 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic Cancer (Part 1)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dai, Guanghai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dai, Guanghai, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782685
- Sponsor's protocol ID
- CSPC-DNY-PC-B01
- Status last verified
- Jan 2025
- First submitted
- 10 Oct 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Irinotecan in Combination With Oxaliplatin and Bevacizumab Versus Liposomal Irinotecan in Combination With 5-FU/LV for the Second-line Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06782685
- Acronym / sponsor ID
- CSPC-DNY-PC-B01
- Conditions
- Advanced Pancreatic Cancer (Part 1)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Dai, GuanghaiUniversity, hospital or other
- Study start
- 23 Jun 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Jan 2025 (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.
Purpose of the study Phase I study: to explore the optimal dose combination of irinotecan liposome + oxaliplatin + bevacizumab regimen, irinotecan liposome + oxaliplatin Phase II study: to evaluate the safety and efficacy of the second-line treatment regimen of irinotecan liposome combined with oxaliplatin and bevacizumab compared to the second-line treatment regimen of irinotecan liposome combined with 5-FU/LV in advanced pancreatic cancer Sample size 138 cases Phase I Crawl, sample size 9-18 cases. Phase II randomized controlled clinical study, historical data NAPOLI-1 study, ORR of 8.8% for irinotecan liposome + 5-FU/LV, planned trial arm ORR upgrade to 25%, calculated at 60 cases in each arm.
Subject population Patients with advanced pancreatic cancer diagnosed after failure of first-line therapy, confirmed by histopathology or cytopathology, who meet the inclusion criteria and do not meet the exclusion criteria.
Phase I design:
Liposomal irinotecan + oxaliplatin + bevacizumab, 2-week regimen Liposomal irinotecan: start exploring with 50mg/m2 dose, preset 50mg/m2, 60mg/m2, 2 dose groups, 90min IV infusion, d1; Oxaliplatin: explored from 60mg/m2 dose, preset 60mg/m2, 85mg/m2, 2 dose groups, IV infusion, d1; Bevacizumab: 5 mg/kg, i.v., d1; Phase II study design.
Trial group:
Irinotecan liposomal: RP2D, i.v., 90min, d1; Oxaliplatin: RP2D, i.v., d1; Bevacizumab: 5mg/kg, i.v., d1; Cycles every 2 weeks until disease progression or intolerable; imaging every 3 treatment cycles/1.5 months.
Control:
Liposomal irinotecan: 70 mg/m2 IV for 90 min, d1; Calcium folinate: 400 mg/m2, IV infusion over 30 min, d1; 5-FU: 2400 mg/m2, continuous IV infusion over 46h; Cycles every 2 weeks until disease progression or intolerable; imaging every 3 treatment cycles/1.5 months.
Notes:
If the duration of irinotecan liposome infusion can be extended appropriately based on the patient\'s clinical response; if the patient withdraws from the trial due to intolerance of toxicity (e.g., neurotoxicity or myelotoxicity) induced by one of the drugs, follow up is required until PFS and OS.
Translated with DeepL.com (free version)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposomal combination of oxaliplatin and bevacizumab | Experimental | Drug: Irinotecan liposoma, Drug: oxaliplatin, Drug: bevacizumabTo explore the optimal dose combination of irinotecan liposomes plus oxaliplatin in the regimen of irinotecan liposomes plus oxaliplatin in bevacizumab and determine the recommended dose for phase II |
| Irinotecan liposomal combination of 5-FU/LV | Active comparator | Drug: 5-FU, Drug: LV, Drug: Irinotecan LiposomalStandard treatment |
| Irinotecan liposomal +oxaliplatin +bevacizumab | Experimental | Drug: bevacizumab, Drug: Irinotecan Liposomal, Drug: OxaliplatinPhase II recommended dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18 to 75 years old;
- Patients with pancreatic cancer diagnosed by histopathology or cytology;
- Unresectable disease assessed by multidisciplinary and imaging;
- Subjects who have received prior failed first-line therapy, and recurrence within 6 months of the end of (neo)adjuvant therapy is considered a first-line treatment failure;
- Subjects who have not received platinum-containing or irinotecan drugs for prior first-line therapy;
Key exclusion criteria (12 listed)
- Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and basal cell carcinoma of the skin);
- Uncontrollable pleural effusion or ascites;
- Any known brain metastasis or meningeal metastasis;
- Concomitant use of a potent CYP3A4 inducer within 3 weeks prior to the first dose, or concurrent use of a potent CYP3A4 inhibitor or potent UGT1A1 inhibitor within 3 weeks prior to the first dose;
- Patients undergoing major organ surgery (except needle biopsy, central venous catheterization, port catheterization, stent placement for relief of biliary obstruction, percutaneous hepato-biliary drainage, cholecystostomy) or elective surgical procedures scheduled within 4 weeks prior to the first dose of study drug;
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 |
|---|---|---|
| Irinotecan liposomaExploration started with 50mg/m^2 dose, preset 50mg/m^2, 60mg/m^2, 2 dose groups, IV infusion 90min, d1 | Drug | Irinotecan liposomal combination of oxaliplatin and bevacizumab |
| oxaliplatinExploration started with 60mg/m^2 dose, preset 60mg/m^2, 85mg/m^2, 2 dose groups, IV infusion, d1 | Drug | Irinotecan liposomal combination of oxaliplatin and bevacizumab |
| bevacizumab5mg/kg，i.v.，d1 | Drug | Irinotecan liposomal +oxaliplatin +bevacizumab, Irinotecan liposomal combination of oxaliplatin and bevacizumab |
| 5-FU2400mg/m^2, i.v.，46h | Drug | Irinotecan liposomal combination of 5-FU/LV |
| LV400mg/m^2, i.v.，d1 | Drug | Irinotecan liposomal combination of 5-FU/LV |
| Irinotecan Liposomal70mg/m^2, i.v.，d1 | Drug | Irinotecan liposomal combination of 5-FU/LV |
| Irinotecan LiposomalPhase II recommended dose | Drug | Irinotecan liposomal +oxaliplatin +bevacizumab |
| OxaliplatinPhase II recommended dose | Drug | Irinotecan liposomal +oxaliplatin +bevacizumab |
Primary outcome
To explore the optimal dose combination of irinotecan liposomes plus oxaliplatin in the regimen of irinotecan liposomes plus oxaliplatin in bevacizumab
Time frame: At the end of Cycle 1 (each cycle is 14 days)
The DLT determination criteria are as follows: 1. Hematologic toxicity： * Grade 4 neutropenia with application of granulocyte colony-stimulating factor still persisting for >3 days ; * Grade 3 or above FN; * Grade 3 thrombocytopenia with bleeding and/or need for blood transfusion; * Grade 4 thrombocytopenia; * Grade 4 anemia. 2. Non-hematologic toxicity： ≥ Grade 3 non-hematologic toxicity, except: ① Transient (≤24 hours) Grade 3 fever (>40°C), Grade 3 malaise, Grade 3 headache, Grade 3 nausea, which recovers to Grade 1 or baseline after treatment; Grade 3 vomiting, Grade 3 electrolyte disorders (including hypokalemia, hypophosphatemia, hypocalcemia, etc.), recovery to Grade 1 or baseline within 48 hours after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Related InfoLink provided by the sponsor.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Irinotecan liposoma, oxaliplatin and bevacizumab in people with Advanced Pancreatic Cancer (Part 1), run by Dai, Guanghai at 2 sites 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 12 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guanghai Dai (13801232381, daigh60@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the optimal dose combination of irinotecan liposomes plus oxaliplatin in the regimen of irinotecan liposomes plus oxaliplatin in bevacizumab (time frame: At the end of Cycle 1 (each cycle is 14 days)). 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 20 Jan 2025.