Pancreatic CancerPhase 2NCT06475326
Adebrelimab in Combination With NALIRIFOX in Locally Advanced Pancreatic Cancer
A Phase 2 study testing Adebrelimab, Oxaliplatin 100 MG and Irinotecan liposome in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Adebrelimab, Oxaliplatin 100 MG and Irinotecan liposome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2024to Dec 2025
- Phase
- Phase 2
- 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
- Age 18-75 years old;
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (preferably histologically confirmed);
- Judged by the investigator to be unresectable locally advanced (unresectable criteria refer to the guidelines for the diagnosis and treatment of pancreatic cancer);
- Total bilirubin ≤ 2 mg/dL (subjects with bile duct stents can be enrolled if bilirubin ≤ 2 mg/dL and no cholangitis after stent placement);
- Have not received previous treatment for pancreatic cancer, including radiotherapy, chemotherapy, surgery, etc;
- Have at least one measurable lesion (per RECIST 1.1 criteria). ECOG score is 0~1 points within 28 days before the first dose, laboratory tests with adequate organ function: Blood routine: WBC ≥3.0×109/L; ANC≥1.5×109/L；PLT≥100×109/L； HGB≥90 g/L; Liver function: AST≤2.5×ULN; ALT≤2.5×ULN； TBIL≤1.5×ULN; Renal function: Cr≤1.5×ULN or CrCl ≥60 mL/min; Coagulation function: INR≤1.5, APTT≤1.5×ULN ; There was no obvious abnormality in ECG.
- Male subjects, as well as females of childbearing potential, must use contraception for 3 months from the start of the first dose to the last use of the study drug.
Who cannot join
- Occurrence of distant metastases (for imaging suspicion of peritoneal cancer or ascites, histological or cytological verification such as laparoscopic exploration is required)
- Medical history and complications: Subject has contraindications to surgical resection of pancreatic cancer; Subject has any known active autoimmune disease; Subject has any complications requiring systemic treatment with glucocorticoids such as prednisone (>10mg/day) or has used immunosuppressive drugs within 14 days prior to the first dose; Subject has received tumor vaccine or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin or immune cell therapy) within 1 month before the first dose; Subjects are participating in other clinical trials or have received drug intervention from other clinical trials within 4 weeks prior to the first dose.; Subject has other malignancies requiring treatment; Subject has had a significant prior cardiovascular disease; Subject has a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Laboratory tests: Subject tested positive for HIV serologically; Active hepatitis B (HbsAg positive and HBV-DNA ≥103copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive with the need for antiviral therapy).
- Presence of allergies and adverse drug reactions: Presence of allergy or hypersensitivity to monoclonal antibodies; Presence of allergic reactions to leucovorin, 5-FU, irinotecan, oxaliplatin
- Diseases or abnormal laboratory indicators that in the opinion of the investigator will affect the results of the study, or are not in the interest of the subjects, should be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Weijing Zhang, M.D., Ph.D., 21-64175590, andwater@163.com
About this study
Official title: A Phase II Trial of Adebrelimab in Combination With NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.
Read the detailed description
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.
To assess the surgical resection conversion rate of chemotherapy in addition to immunotherapy for unresectable locally advanced pancreatic cancer (LAPC).
To evaluate the changes in CA19-9 levels, objective response rate (ORR), R0/R1 resection rate, pathologic response (pCR/MPR), event-free survival (EFS), 1 year and 2 years and overall survival (1y-OS, 2y-OS, OS) before and after conversion therapy for unresectable locally advanced pancreatic cancer.
To assess perioperative safety (including surgical morbidity and mortality within 60 days). To evaluate the safety and tolerability of immunotherapy in combination with chemotherapy for conversion therapy for unresectable locally advanced pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Adebrelimab, Oxaliplatin 100 MG, Irinotecan liposome, Calcium Folinate, Fluorouracil
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called PD-L1
Adebrelimab ,20mg/Kg per time, Q4W
Oxaliplatin 100 MGDrug
Oxaliplatin: 60mg/m2, Q2W
Irinotecan liposomeDrug
Irinotecan Liposome: 50mg/m2, Q2W
Calcium FolinateDrug
Also called LV
Calcium Folinate: 400mg/m2, Q2W
FluorouracilDrug
Fluorouracil: 2400mg/m2, Q2W
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab Combined with NALIRIFOX | Experimental | Adebrelimab: 20 mg/kg, intravenous infusion, administered on day 1, every four weeks as a cycle (Q4W)
Chemotherapy:
Oxaliplatin: 60mg/m2, intravenous infusion for 2 hours, administered on day 1 Irinotecan liposome: 50mg/m2, intravenous infusion for more than 90min, administered on the first day LV: 400mg/m2, intravenous infusion for 2 hours, administered on the first day 5-FU: 2400mg/m2, continuous intravenous infusion for 46h, every two weeks as a cycle (Q2W) Receives: Drug: Adebrelimab; Drug: Oxaliplatin 100 MG; Drug: Irinotecan liposome; Drug: Calcium Folinate; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Conversion Rate
The surgery is scheduled to take place after a minimum of 4 weeks from the last dose to allow the effects of the drug to wear off. The eligible subjects can undergo surgery within 8 weeks from the last dose.
Measured: 8 weeks
Secondary outcomes (4)
Pathologic response rate (pCR/MPR)
pCR is defined as the proportion of subjects with complete disappearance of cancer cells from tumor lesions and lymph nodes. MPR is defined as the proportion of cancer cells in tumor lesions and lymph nodes < 10% of subjects, and the viable cells of carcinoma in situ are not included in the calculation of pCR. All tumor tissue and associated lymph node tissue samples should be grossly examined. Tissue samples should be sectioned at a thickness of 0.5 cm. Pathological evaluation should be performed for more extensive tumors with at least 1.0 cm thick sections.
Measured: up to approximately 1 years
Objective response rate (ORR)
ORR=(CR+PR)/ITT*100%, and the binomial distribution was used to calculate its 95%CI.
Measured: up to approximately 1 years
Event-free survival (EFS)
defined as the time from the start of treatment to the occurrence of any disease progression affecting surgery, postoperative disease progression or recurrence (per RECIST v1.1), or death due to any cause, whichever occurs first.
Measured: up to approximately 1 years
Overall survival (OS)
defined as the time from the first dose to death from any cause, whichever occurs first. Participants who were still alive at the last follow-up had OS as data censored at the time of the last follow-up. For participants lost to follow-up, OS was counted as data censored as the time to last confirmed survival before loss-to-follow.
Measured: up to approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start5 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 87 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
- Weijing Zhang, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475326
- Sponsor's protocol ID
- CSPAC-29
- Status last verified
- Aug 2024
- First submitted
- 20 Jun 2024
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Adebrelimab in Combination With NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06475326
- Acronym / sponsor ID
- CSPAC-29
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jun 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.
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.
Detailed description
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.
To assess the surgical resection conversion rate of chemotherapy in addition to immunotherapy for unresectable locally advanced pancreatic cancer (LAPC).
To evaluate the changes in CA19-9 levels, objective response rate (ORR), R0/R1 resection rate, pathologic response (pCR/MPR), event-free survival (EFS), 1 year and 2 years and overall survival (1y-OS, 2y-OS, OS) before and after conversion therapy for unresectable locally advanced pancreatic cancer.
To assess perioperative safety (including surgical morbidity and mortality within 60 days). To evaluate the safety and tolerability of immunotherapy in combination with chemotherapy for conversion therapy for unresectable locally advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab Combined with NALIRIFOX | Experimental | Drug: Adebrelimab, Drug: Oxaliplatin 100 MG, Drug: Irinotecan liposome, Drug: Calcium Folinate, Drug: FluorouracilAdebrelimab: 20 mg/kg, intravenous infusion, administered on day 1, every four weeks as a cycle (Q4W) Chemotherapy: Oxaliplatin: 60mg/m2, intravenous infusion for 2 hours, administered on day 1 Irinotecan liposome: 50mg/m2, intravenous infusion for more than 90min, administered on the first day LV: 400mg/m2, intravenous infusion for 2 hours, administered on the first day 5-FU: 2400mg/m2, continuous intravenous infusion for 46h, every two weeks as a cycle (Q2W) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years old;
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (preferably histologically confirmed);
- Judged by the investigator to be unresectable locally advanced (unresectable criteria refer to the guidelines for the diagnosis and treatment of pancreatic cancer);
- Total bilirubin ≤ 2 mg/dL (subjects with bile duct stents can be enrolled if bilirubin ≤ 2 mg/dL and no cholangitis after stent placement);
- Have not received previous treatment for pancreatic cancer, including radiotherapy, chemotherapy, surgery, etc;
Key exclusion criteria (5 listed)
- Occurrence of distant metastases (for imaging suspicion of peritoneal cancer or ascites, histological or cytological verification such as laparoscopic exploration is required)
- Medical history and complications: Subject has contraindications to surgical resection of pancreatic cancer; Subject has any known active autoimmune disease; Subject has any complications requiring systemic treatment with glucocorticoids such as prednisone (>10mg/day) or has used immunosuppressive drugs within 14 days prior to the first dose; Subject has received tumor vaccine or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin or immune cell therapy) within 1 month before the first dose; Subjects are participating in other clinical trials or have received drug intervention from other clinical trials within 4 weeks prior to the first dose.; Subject has other malignancies requiring treatment; Subject has had a significant prior cardiovascular disease; Subject has a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Laboratory tests: Subject tested positive for HIV serologically; Active hepatitis B (HbsAg positive and HBV-DNA ≥103copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive with the need for antiviral therapy).
- Presence of allergies and adverse drug reactions: Presence of allergy or hypersensitivity to monoclonal antibodies; Presence of allergic reactions to leucovorin, 5-FU, irinotecan, oxaliplatin
- Diseases or abnormal laboratory indicators that in the opinion of the investigator will affect the results of the study, or are not in the interest of the subjects, should be excluded.
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 |
|---|---|---|
| AdebrelimabAlso: PD-L1Adebrelimab ,20mg/Kg per time, Q4W | Drug | Adebrelimab Combined with NALIRIFOX |
| Oxaliplatin 100 MGOxaliplatin: 60mg/m2, Q2W | Drug | Adebrelimab Combined with NALIRIFOX |
| Irinotecan liposomeIrinotecan Liposome: 50mg/m2, Q2W | Drug | Adebrelimab Combined with NALIRIFOX |
| Calcium FolinateAlso: LVCalcium Folinate: 400mg/m2, Q2W | Drug | Adebrelimab Combined with NALIRIFOX |
| FluorouracilFluorouracil: 2400mg/m2, Q2W | Drug | Adebrelimab Combined with NALIRIFOX |
Primary outcome
Surgical Conversion Rate
Time frame: 8 weeks
The surgery is scheduled to take place after a minimum of 4 weeks from the last dose to allow the effects of the drug to wear off. The eligible subjects can undergo surgery within 8 weeks from the last dose.
4 secondary outcomes
Pathologic response rate (pCR/MPR)
Time frame: up to approximately 1 years
Objective response rate (ORR)
Time frame: up to approximately 1 years
Event-free survival (EFS)
Time frame: up to approximately 1 years
Overall survival (OS)
Time frame: up to approximately 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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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.
Weijing Zhang study chair
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 2 study testing Adebrelimab, Oxaliplatin 100 MG and Irinotecan liposome in people with Pancreatic Cancer, 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 7 inclusion and 5 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 9 Aug 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Si Shi, PHD (+86-021-64179375, shisi@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Conversion Rate (time frame: 8 weeks). 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 9 Aug 2024.