Neoadjuvant ChemotherapyPhase 2CAPT-02NCT06172036
Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab
A Phase 2 study testing irinotecan liposome + oxaliplatin + 5-FU / LV and Adebellizumab in people with Neoadjuvant Chemotherapy and Resectable Pancreatic Cancer, run by Zhejiang University.
Trial summary
To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoadjuvant Chemotherapy, Resectable Pancreatic Cancer
- What is being tested?
- irinotecan liposome + oxaliplatin + 5-FU / LV and Adebellizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2024to 20 Jan 2027
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years old, male or female;
- According to the NCCN clinical practice guidelines (2023.V2 version), multidisciplinary and imaging evaluation for patients with resectable pancreatic cancer, resectable defined as: by imaging examination, the criteria of radical resection of tumor is no distant metastasis, the artery (trunk celiac, superior mesenteric artery or common hepatic artery), and the tumor did not invade the superior mesenteric vein and portal vein, or invasion but not more than 180 and the venous contour is normal.
- Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or research drug therapy; 4. At least one measurable lesion must be used as the target lesion (according to the RECIST v1.1 criteria);
- 5. ECOG：0～1； 6. Expected survival period of 3 months; 7. Main organ function, meeting the following criteria (without receiving any blood components, cell growth factors within the 14 days prior to randomization):
- Neutrophils 1.5 * 109 / L; platelets 80 * 109 / L; 9 g/dl hemoglobin and 3 g/dl serum albumin;
- The upper limit of total bilirubin is 1.5 times (biliary obstruction allows biliary drainage); the upper limit of ALT and AST is 3 times (for patients of liver metastasis, it can be relaxed to 5 times the upper limit of normal);
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- The upper limit of normal serum creatinine is 1.5 times, and the creatinine clearance is 60ml / min;
- The upper limit of INR is 1.5 times and the upper limit of APTT is 1.5 times (for stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin and INR can be screened within the expected treatment range of anticoagulant);
- ECG: QTcF 450ms (male), 470ms (female);
- Cardiac color ultrasound: LVEF (left ventricular ejection fraction) 50%; 8. Women of childbearing age must have a negative blood pregnancy test within 3 days before randomization and be willing to use appropriate contraception during the trial and within 6 months of treatment. For men, it should be surgical sterilization, or consent to use appropriate methods of contraception during the study period and within 3 months after the end of treatment; 9. Subjects volunteered to join the study and signed the informed consent form.
Who cannot join
- Patients with pancreatic cancer arising from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic pancreoblastoma, and solid-pseudopapillary tumors;
- Patients with known central nervous system metastases;
- Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);
- Within 2 weeks before randomization, the third space effusion (such as a large amount of pleural fluid) (no intervention after removing the drainage tube);
- Patients with clinical symptoms of ascites, requiring puncture, drainage, who have received ascites drainage within the previous 3 months (only a small amount of ascites on imaging and controllable, except those without clinical symptoms);
- Current subjects with interstitial pneumonia or interstitial lung disease, or a history requiring hormonal therapy, or other pulmonary fibrosis, mechanical pneumonia (e. g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, idiopathic pneumonia or active CT during screening that may interfere with the judgment and management of immune-related pulmonary toxicity; active tuberculosis;
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- Patients with active autoimmune disease or a history of autoimmune disease that may relapse [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, optis, enteritis, vasculitis, nephritis, hyperthyroidism, reduced thyroid function (only controlled by hormone replacement therapy can be enrolled)]; skin diseases without systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes or asthma in childhood has been completely alleviated in adults without any intervention;
- Known peripheral neuropathy (CTCAE Grade 3);
- Known dihydropyrimidine dehydrogenase (low activity) or deficiency;
- Severe infection (CTCAE> 2), such as severe pneumonia, bacteremia, infectious complications, requiring hospitalization, occurred within 4 weeks of randomization; symptoms and signs of infection within 2 weeks of randomization (except in cases of prophylactic antibiotics);
- Received any of the following treatments:
- (1)Concomitant medication containing CYP3A4, CYP2C8 strong inhibitor / strong inducer or strong UGT1A1 inhibitor within 2 weeks before randomization; (2)Immunosuppressants or systemic hormone therapy within 2 weeks prior to randomization to achieve immunosuppressive purposes (dose> 10mg prednisone / day or other efficacy hormones); (3)Received radiation therapy within 2 weeks before randomization; (4)Receiving major surgery (such as thoracotomy, laparotomy, etc.) within 4 weeks before randomization; (5)Have received any other clinical study drug treatment within 4 weeks before randomization, except for an observational (non-interventional) clinical study or interventional clinical study follow-up.
- 12. Abnormal coagulation, bleeding tendency or undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (100mg / day), low molecular weight heparin (enoxaparin 40mg / day and other low molecular weight heparin at its equivalent doses) is allowed; 13. cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure; (2) unstable angina; (3) myocardial infarction within 6 months; (4) patients with clinically significant supraventricular or ventricular arrhythmias who need treatment or intervention; 14. Malignant tumors other than pancreatic cancer within 5 years before randomization, except for adequately treated cervical carcinoma in situ, skin basal cell, or squamous epithelial cell carcinoma; 15. Those known to be allergic to PD-L1, irinotecan liposomal, other liposomal products, oxaliplatin, 5-FU, leucovorin and any of the components of the above products; 16. Those known to have acquired immune deficiency syndrome (AIDS) or HIV test positive, active syphilis; 17. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 18. By the judgment of the investigator, the subject has other factors that may be forced to terminate the study, such as non-compliance protocol, with other serious diseases (including mental illness) need to combine treatment, clinical significant laboratory value seriously abnormal, family or social factors, may affect the safety or trial data collection of subjects.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Multi-cohort, Randomized, Phase II Study of Irinotecan Liposome Combined With 5-FU / LV and Oxaliplatin for Resectable Pancreatic Cancer With or Without Addebelizumab
To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate
Read the detailed description
For patients with surgically resectable pancreatic cancer who have not received any anti-tumor therapy. To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate.
- Being tested
- irinotecan liposome + oxaliplatin + 5-FU / LV, Adebellizumab
- Keywords
- resectable pancreatic cancer, irinotecan liposomes, Adebellizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecan liposome + oxaliplatin + 5-FU / LVDrug
Efficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer
AdebellizumabDrug
Efficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Preoperative adliberlizumab + irinotecan liposome + oxaliplatin + 5-FU / LV (28 days as one cycle, 2 treatment cycles). Surgery was performed within 2 to 4 weeks after completion of neoadjuvant therapy and addebelizumab + irinotecan liposomes + oxaliplatin + 5-FU / LV (28 days as one cycle, 4 treatment cycles) within 4 to 6 weeks after surgery, followed by maintenance therapy with addebelizumab until disease progression or intolerable toxicity. The cumulative postoperative duration of adbelizumab should not exceed 1 year. Tumor recurrence, safety and survival follow-up was evaluated after completion of the drug. Receives: Drug: irinotecan liposome + oxaliplatin + 5-FU / LV; Drug: Adebellizumab |
| Arm B | Experimental | Irinotecan liposome + oxaliplatin + 5-FU / LV (28 days one cycle, 2 treatment cycles), 2-4 weeks after completion of neoadjuvant therapy and 4-6 weeks after surgery, adjuvant irinotecan liposome + oxaliplatin + 5-FU / LV (28 days one cycle, 4 treatment cycles). Tumor recurrence, safety and survival follow-up were performed after the end of the adjuvant treatment phase. Receives: Drug: irinotecan liposome + oxaliplatin + 5-FU / LV |
| Arm C | Active comparator | Upfront surgery, and postoperative adjuvant regimen as with ArmB. Tumor recurrence, safety and survival follow-up were performed after the end of the adjuvant treatment phase. Receives: Drug: irinotecan liposome + oxaliplatin + 5-FU / LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month EFS rate
the proportion of subjects with EFS events within one year.
Measured: Up to 2 years.
Secondary outcomes (6)
Overall Survival
Defined as the time from random to death from any cause
Measured: Up to 2 years.
Event free survival
Defined as the time from randomization to disease progression, disease recurrence or death from any cause.
Measured: Up to 2 years.
Disease free survival
Defined as the time from randomization to disease recurrence or death from any cause.
Measured: Up to 2 years.
Objective response rate
Evaluation of the ORR by the investigator per RECIST v1.1 criteria means the proportion of subjects with the best overall efficacy of CR or PR. If the efficacy reaches CR and PR, the subject must be reviewed 4 weeks after the initial evaluation.
Measured: Up to 2 years.
R0 resection rate
Defined as the proportion of subjects assessed as R0 resection.
Measured: Up to 2 years.
Incidence of Treatment-Emergent Adverse Events
Incidence of Adverse events (AEs) / serious adverse events (SAEs) (as per NCI-CTCAE 5.0)
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start20 Jan 2024 (estimated)
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant ChemotherapyStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172036
- Sponsor's protocol ID
- CAPT-02
- Acronym
- CAPT-02
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 15 Dec 2023
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multi-cohort, Randomized, Phase II Study of Irinotecan Liposome Combined With 5-FU / LV and Oxaliplatin for Resectable Pancreatic Cancer With or Without Addebelizumab
- ClinicalTrials.gov ID
- NCT06172036
- Acronym / sponsor ID
- CAPT-02 / CAPT-02
- Keywords
- resectable pancreatic cancer, irinotecan liposomes, Adebellizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 15 Dec 2023 (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.
To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate
Detailed description
For patients with surgically resectable pancreatic cancer who have not received any anti-tumor therapy. To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: irinotecan liposome + oxaliplatin + 5-FU / LV, Drug: AdebellizumabPreoperative adliberlizumab + irinotecan liposome + oxaliplatin + 5-FU / LV (28 days as one cycle, 2 treatment cycles). Surgery was performed within 2 to 4 weeks after completion of neoadjuvant therapy and addebelizumab + irinotecan liposomes + oxaliplatin + 5-FU / LV (28 days as one cycle, 4 treatment cycles) within 4 to 6 weeks after surgery, followed by maintenance therapy with addebelizumab until disease progression or intolerable toxicity. The cumulative postoperative duration of adbelizumab should not exceed 1 year. Tumor recurrence, safety and survival follow-up was evaluated after completion of the drug. |
| Arm B | Experimental | Drug: irinotecan liposome + oxaliplatin + 5-FU / LVIrinotecan liposome + oxaliplatin + 5-FU / LV (28 days one cycle, 2 treatment cycles), 2-4 weeks after completion of neoadjuvant therapy and 4-6 weeks after surgery, adjuvant irinotecan liposome + oxaliplatin + 5-FU / LV (28 days one cycle, 4 treatment cycles). Tumor recurrence, safety and survival follow-up were performed after the end of the adjuvant treatment phase. |
| Arm C | Active comparator | Drug: irinotecan liposome + oxaliplatin + 5-FU / LVUpfront surgery, and postoperative adjuvant regimen as with ArmB. Tumor recurrence, safety and survival follow-up were performed after the end of the adjuvant treatment phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 years old, male or female;
- According to the NCCN clinical practice guidelines (2023.V2 version), multidisciplinary and imaging evaluation for patients with resectable pancreatic cancer, resectable defined as: by imaging examination, the criteria of radical resection of tumor is no distant metastasis, the artery (trunk celiac, superior mesenteric artery or common hepatic artery), and the tumor did not invade the superior mesenteric vein and portal vein, or invasion but not more than 180 and the venous contour is normal.
- Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or research drug therapy; 4. At least one measurable lesion must be used as the target lesion (according to the RECIST v1.1 criteria);
- 5. ECOG：0～1； 6. Expected survival period of 3 months; 7. Main organ function, meeting the following criteria (without receiving any blood components, cell growth factors within the 14 days prior to randomization):
- Neutrophils 1.5 * 109 / L; platelets 80 * 109 / L; 9 g/dl hemoglobin and 3 g/dl serum albumin;
Key exclusion criteria (13 listed)
- Patients with pancreatic cancer arising from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic pancreoblastoma, and solid-pseudopapillary tumors;
- Patients with known central nervous system metastases;
- Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);
- Within 2 weeks before randomization, the third space effusion (such as a large amount of pleural fluid) (no intervention after removing the drainage tube);
- Patients with clinical symptoms of ascites, requiring puncture, drainage, who have received ascites drainage within the previous 3 months (only a small amount of ascites on imaging and controllable, except those without clinical symptoms);
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 liposome + oxaliplatin + 5-FU / LVEfficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer | Drug | Arm A, Arm B, Arm C |
| AdebellizumabEfficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer | Drug | Arm A |
Primary outcome
12-month EFS rate
Time frame: Up to 2 years.
the proportion of subjects with EFS events within one year.
6 secondary outcomes
Overall Survival
Time frame: Up to 2 years.
Event free survival
Time frame: Up to 2 years.
Disease free survival
Time frame: Up to 2 years.
Objective response rate
Time frame: Up to 2 years.
R0 resection rate
Time frame: Up to 2 years.
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 2 years.
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 15 Dec 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irinotecan liposome + oxaliplatin + 5-FU / LV and Adebellizumab in people with Neoadjuvant Chemotherapy and Resectable Pancreatic Cancer, run by Zhejiang 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 13 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: opening soon, as of the sponsor's last update on 15 Dec 2023. 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 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 Tingbo Liang, PhD (+86 19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month EFS rate (time frame: Up to 2 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 15 Dec 2023.