Pancreas CancerPhase 1/2CISPD-7NCT06572813
Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer
A Phase 1/2 study testing Bortezomib Injection, Sintilimab and mFOLFIRINOX in people with Pancreas Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is an single-center, prospective, open-label clinical trial, to explore the safty and efficacy of combination of Bortezomib, Sindilizumab, and mFOLFIRINOX Chemotherapy (oxaliplatin, fluorouracil, irinotecan, leucovorin) in metastatic pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Bortezomib Injection, Sintilimab and mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to Mar 2028
- 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
- Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
- Recurrent disease or metastatic disease (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
- Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy
- ECOG score 0 or 1.
- Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
- ALT and AST are less than 2 x ULN.
- Signed informed consent.
Who cannot join
- History of participation of other clinical trails within 4 weeks
- History of autoimmune disease or other condition receiving glucocorticoid treatment
- History of receiving chemotherapy within 2 weeks
- History of radiotherapy and molecular target therapy within 2 weeks
- History if active tuberculosis
- History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
Show all 15Show fewer
- Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
- Hematological precancerous diseases, such as myelodysplastic syndromes.
- Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
- Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
- Preexisting neuropathy > 1 (NCI CTCAE).
- Immune deficiency syndrome, such as active tuberculosis and HIV infection.
- Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
- Severe serious wounds, ulcers or fractures.
- Clinical evaluation is unacceptable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, 310000
Yiwen Chen, MD, 86+15088682641, cherry0705@zju.edu.cn
About this study
Official title: Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for First-line Treatment of Metastatic Pancreatic Cancer：An Exploratory Clinical Trial
This is an single-center, prospective, open-label clinical trial, to explore the safty and efficacy of combination of Bortezomib, Sindilizumab, and mFOLFIRINOX Chemotherapy (oxaliplatin, fluorouracil, irinotecan, leucovorin) in metastatic pancreatic cancer
Read the detailed description
Phase 1 (Evaluation of Drug Tolerance) Primary objective: To evaluate the tolerability of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer, and to determine the dose of bortezomib in the combination regimen; Secondary objectives: To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Phase 2 (Dose Expansion) Primary objective: To evaluate the tolerability and efficacy of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Secondary Objective: ORR; PFS; OS; and to evaluate the immunogenicity and safety of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; and to explore biomarkers related to combination therapy.
- Conditions
- Pancreas Cancer
- Being tested
- Bortezomib Injection, Sintilimab, mFOLFIRINOX
- Keywords
- metastatic pancreatic cancer, bortezomib, PD-1 antibody, chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib InjectionDrug
Bortezomib Injection, a kind of chemotherapy drug
SintilimabDrug
PD-1 antibody
mFOLFIRINOXDrug
Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (Drug Tolerance Evaluation) | Experimental | Using a 3 + 3 trial design, bortezomib dose exploration was performed to determine the stage 2 bortezomib dose. The number of participants at this stage is 6-9. Receives: Drug: Bortezomib Injection; Drug: Sintilimab; Drug: mFOLFIRINOX |
| Phase 2 (Dose extension) | Experimental | Phase 2: This phase will adopt competitive enrollment, and the Bayesian prediction probability method will be used to monitor the main efficacy index of the trial ORR in real time to determine the early termination or continue the trial. A maximum number of 57 patients were enrolled in this stage. Receives: Drug: Bortezomib Injection; Drug: Sintilimab; Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0，including Complete Blood Count, liver function, renal function lab test and other blood test will be evaluated by using CTCAE 5.0 during study.
Measured: Up to 2 years.
Phase 2: Objective reponse rate (ORR)
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase 2
Measured: Up to 2 years
Secondary outcomes (4)
Disease control rate (DCR)
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during phase 2
Measured: Up to 2 years
Duration of remission （DoR）
The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause during phase 2
Measured: Up to 2 years
Progression-free survival （PFS）
The time from enrolled to disease pregression or death from any cause during phase 2
Measured: Up to 2 years
Overall survival (OS)
The time from enrolled to death from any cause during phase 2
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 posted27 Aug 2024
- Study start15 Nov 2024
- Primary completion1 Sep 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 (Evaluation of Drug Tolerance) Primary objective: To evaluate the tolerability of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer, and to determine the dose of bortezomib in the combination regimen; Secondary objectives: To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Phase 2 (Dose Expansion) Primary objective: To evaluate the tolerability and efficacy of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; Secondary Objective: To evaluate the immunogenicity and safety of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; and to explore biomarkers related to combination therapy.
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, First Affiliated Hospital of Zhejiang University
- Investigators
- Tingbo Liang, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572813
- Sponsor's protocol ID
- CISPD-7
- Acronym
- CISPD-7
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 10 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for First-line Treatment of Metastatic Pancreatic Cancer：An Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT06572813
- Acronym / sponsor ID
- CISPD-7 / CISPD-7
- Conditions
- Pancreas Cancer
- Keywords
- metastatic pancreatic cancer, bortezomib, PD-1 antibody, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Aug 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.
This is an single-center, prospective, open-label clinical trial, to explore the safty and efficacy of combination of Bortezomib, Sindilizumab, and mFOLFIRINOX Chemotherapy (oxaliplatin, fluorouracil, irinotecan, leucovorin) in metastatic pancreatic cancer
Detailed description
Phase 1 (Evaluation of Drug Tolerance) Primary objective: To evaluate the tolerability of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer, and to determine the dose of bortezomib in the combination regimen; Secondary objectives: To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Phase 2 (Dose Expansion) Primary objective: To evaluate the tolerability and efficacy of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Secondary Objective: ORR; PFS; OS; and to evaluate the immunogenicity and safety of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; and to explore biomarkers related to combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 (Evaluation of Drug Tolerance) Primary objective: To evaluate the tolerability of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer, and to determine the dose of bortezomib in the combination regimen; Secondary objectives: To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Phase 2 (Dose Expansion) Primary objective: To evaluate the tolerability and efficacy of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; Secondary Objective: To evaluate the immunogenicity and safety of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; and to explore biomarkers related to combination therapy.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (Drug Tolerance Evaluation) | Experimental | Drug: Bortezomib Injection, Drug: Sintilimab, Drug: mFOLFIRINOXUsing a 3 + 3 trial design, bortezomib dose exploration was performed to determine the stage 2 bortezomib dose. The number of participants at this stage is 6-9. |
| Phase 2 (Dose extension) | Experimental | Drug: Bortezomib Injection, Drug: Sintilimab, Drug: mFOLFIRINOXPhase 2: This phase will adopt competitive enrollment, and the Bayesian prediction probability method will be used to monitor the main efficacy index of the trial ORR in real time to determine the early termination or continue the trial. A maximum number of 57 patients were enrolled in this stage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
- Recurrent disease or metastatic disease (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
- Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy
- ECOG score 0 or 1.
- Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
Key exclusion criteria (15 listed)
- History of participation of other clinical trails within 4 weeks
- History of autoimmune disease or other condition receiving glucocorticoid treatment
- History of receiving chemotherapy within 2 weeks
- History of radiotherapy and molecular target therapy within 2 weeks
- History if active tuberculosis
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 |
|---|---|---|
| Bortezomib InjectionBortezomib Injection, a kind of chemotherapy drug | Drug | Phase 1 (Drug Tolerance Evaluation), Phase 2 (Dose extension) |
| SintilimabPD-1 antibody | Drug | Phase 1 (Drug Tolerance Evaluation), Phase 2 (Dose extension) |
| mFOLFIRINOXCombination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium | Drug | Phase 1 (Drug Tolerance Evaluation), Phase 2 (Dose extension) |
Primary outcome
Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 2 years.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0，including Complete Blood Count, liver function, renal function lab test and other blood test will be evaluated by using CTCAE 5.0 during study.
Phase 2: Objective reponse rate (ORR)
Time frame: Up to 2 years
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase 2
4 secondary outcomes
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of remission （DoR）
Time frame: Up to 2 years
Progression-free survival （PFS）
Time frame: Up to 2 years
Overall survival (OS)
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 10 Jan 2025.
- 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.
Tingbo Liang principal investigator
First Affiliated Hospital of Zhejiang University
1 site 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 Bortezomib Injection, Sintilimab and mFOLFIRINOX in people with Pancreas Cancer, run by First Affiliated Hospital of Zhejiang 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 7 inclusion and 15 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 10 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 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 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 Tingbo Liang (+8619941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: Up to 2 years.). The study lists 2 primary outcomes in all. 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 10 Jan 2025.