Pancreatic Cancer Metastatic to LiverPhase 2NCT06531278
Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety
A Phase 2 study testing Irinotecan liposome, Adebrelimab and Oxaliplatin in people with Pancreatic Cancer Metastatic to Liver, run by Jiang Long at 1 site in China.
Trial summary
1. Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Metastatic to Liver
- What is being tested?
- Irinotecan liposome, Adebrelimab and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2024to 31 Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily join this study and sign the informed consent form
- Age: 18-75 years old (inclusive), male or female
- Histologically confirmed pancreatic cancer liver metastases and no previous treatment of any systemic anti-swelling tumor treatment
- No central nervous system metastases
- No adjuvant therapy within 6 months prior to enrollment
- ECOG PS: 0~1 points
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- Estimated survival ≥ 12 weeks
- Normal function of major organs, meeting the following requirements (7 prior to initiation of study treatment days): (1) Routine blood examination: (No blood transfusion and no use of granules within 14 days before screening.) Cell colony-stimulating factor [G-CSF], not corrected with medication):1) Hemoglobin [HB]≥90g/L; 2) Absolute neutrophil count [ANC] ≥1.5×10 9 /L； 3) Platelets [PLT] ≥80×10 9 /L； (2) Blood biochemistry tests must meet the following criteria (no transfusion in the 14 days before screening Protein): 1) Serum total bilirubin [TBIL] ≤ 1.5 times the upper limit of normal (ULN); 2) Alanine aminotransferase [ALT], aspartate aminotransferase [AST]<2.5×ULN ； If there is liver metastasis, ALT and AST≤5×ULN； 3) Blood creatinine [Cr]≤1×ULN or endogenous creatinine clearance rate > 50ml/min (Cockcroft-Gault formula); (3) International normalized ratio [INR] ≤ 2.3 or prothrombin time [PT] exceeding Over the range of normal controls≤6 seconds: (4) Urine protein < 2+ (if urine protein ≥ 2+, you can urinate eggs for 24 hours White quantitative, 24-hour urine protein quantification <1.0g can be enrolled);
- Women of childbearing potential must have a pregnancy test (serum or urine) within 7 days prior to enrollment The result is negative and voluntarily during the observation period and after the last dose of study drug8 Use of appropriate methods of contraception within a week; For males, it should be surgically sterile, or Agrees to adopt appropriate during the observation period and for 8 weeks after the last dose of study drug method contraception
- Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol.
Who cannot join
- Other active malignancies within 5 years or concomitantly
- Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) in accordance with: New York Heart Association (NYHA) criteria grade II or greater cardiac insufficiency or Cardiac ultrasonography: LVEF (left ventricular ejection fraction) <50%; (2) Instability Stereotyped angina; (3) Myocardial infarction within 1 year prior to the start of study treatment Die; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention: (5) QTc>450ms (male); QTc>470ms (Women) (The QTc interval is calculated by Fridericia's formula; If the QTc is abnormal, interval can be used Approximately 2 minutes for three consecutive tests, taking the average);
- Those who have high blood pressure and cannot be reduced to the normal range by antihypertensive drug treatment (admitted Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (based on 2 measurements of ≥ The mean of the BP readings obtained), which is allowed to be achieved through the use of antihypertensive therapy above parameters
- Coagulation abnormalities (INR>1.5×ULN, APTT>1.5×ULN), with: Bleeding tendency
- Active bleeding
- Uncontrolled active infection, chronic infectious disease, immunodeficiency syndrome
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- Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥10 3 copy number or ≥1000 U/ml)
- Presence of active autoimmune disease or history of autoimmune disease with possible recurrence 9. Known history of severe allergy to the study drug
- Uncontrolled infection at screening
- Other patients who are considered by the treating physician to be unsuitable for inclusion
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
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200040
Jiang Long, MD, +86 18017317460, jiang.long@shgh.cn
Jiang Long, MD
About this study
- Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer
- Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis
Read the detailed description
Pancreatic cancer is a cancer of the digestive system with a very high degree of malignancy and a very poor prognosis. In recent years, morbidity and death. The rate shows a clear upward trend at home and abroad. Global cancer statistics in 2020 show that there are new pancreas cases worldwide each year. There are about 495,000 cases of adenocarcinoma and about 466,000 deaths from pancreatic cancer each year. Statistical tables for 2020. In the United States, there are about 57,600 new cases of pancreatic cancer every year, and about 47,050 deaths due to pancreatic cancer each year. Data from pancreatic cancer collected by the National Cancer Center of China in 2019. show that the incidence of pancreatic cancer in Chinese is:6.92 per 100,000, with new cases accounting for about 4.31% of all malignant tumors; The case fatality rate is 6.16 per 100,000 and deaths per year Cases account for about 3.78% of all malignancies. The specific etiology and pathogenesis of pancreatic cancer are unclear, and most (85%). It is an adenocarcinoma originating from the ductal epithelium. Early symptoms are atypical, and most patients are diagnosed locally advanced or out. Now distant metastasis. In the past decade, the first-line treatment regimen for pancreatic cancer has been AG, FOLFIRINOX, GS as the commonly used chemotherapy regimens, and the median OS was 8.5 months, 11.1 months, and 10.1 months, respectively. First-line treatment for pancreatic cancer still needs to be explored. The advent of plastid Iriconia has changed the landscape of first-line treatments, and the NAPOLI-3 study compared NALIRINOX (liposome irinotecan, oxaliplatin, fluorouracil, leucovorin) and AG regimens in the first-line treatment of metastatic pancreatic cancer and safety, with a median follow-up of 16.1 months, showed that the median OS of NALIRINOX versus AG was respectively 11.1 versus 9.2 months (HR 0.83 [95% CI 0.70-0.99]; p=0.036), and the median PFS was 7.4 vs. 5.6, respectively months (HR 0.69 [0.58-0.83]; p<0.0001), the ORR was 42% and 36%, respectively. Based on this research The FDA approved liposomal irinotecan in combination with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreas Indications for adenocarcinoma.
Jiangsu Hengrui Pharmaceutical Co., Ltd. developed irinotecan hydrochloride liposome injection (HR070803) has both protection Protective, long-term cyclic and passively targeted. HR070803 combination with 5-FU/LV for second-line treatment of locally advanced or metastatic pancreas after failure of gemcitabine therapy Adenocarcinoma. Significantly prolonged the subject's OS compared to placebo in combination with 5-FU/LV, with a clinically meaningful difference, Significantly lower risk of death. In addition, HR070803 in combination with 5-FU/LV may also prolong the subject's PFS and TTF, and improve ORR and CA19-9 response rates. At the same time, HR070803 combined with 5-FU/LV in advanced pancreas. The type of AE observed in the treatment of adenocarcinoma is consistent with that of regular irinotecan, and there are gastrointestinal reactions, hematotoxic. It is less sexual, well tolerated, and safe and controllable.
Based on the above evidence, this study explored the efficacy and safety of adebelimab, irinotecan liposome, oxaliplatin, fluorouracil, and leucovorin in the first-line treatment of advanced metastatic pancreatic cancer.
- Conditions
- Pancreatic Cancer Metastatic to Liver
- Being tested
- Irinotecan liposome, Adebrelimab, Oxaliplatin, Fluorouracil, Calcium folinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposomeDrug
- Patients are planned to receive irinotecan liposomal (60 mg/m2; d1) of every cycle.
- 27 days a cycle
AdebrelimabDrug
- Patients are planned to receive Adebrelimab (20 mg/kg; d1) of every cycle.
- 27 days a cycle
OxaliplatinDrug
- Patients are planned to receive Oxaliplatin (85 mg/m2; d1) of every cycle.
- 27 days a cycle
FluorouracilDrug
- Patients are planned to receive fluorouracil (2400mg/m2; d1) of every cycle.
- 27 days a cycle
Calcium folinateDrug
- Patients are planned to receive Calcium folinate (400mg/m2; d1) of every cycle.
- 27 days a cycle
| Study group | Role | What they receive |
|---|---|---|
| first-line treatment of pancreatic cancer liver metastasis efficacy and safety | Experimental | Adebelimab combined with irinotecan liposomal injection, oxaliplatin, Fluorouracil and calcium folinate Receives: Drug: Irinotecan liposome; Drug: Adebrelimab; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Calcium folinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The proportion of patients whose tumors shrink to a certain amount for a certain period of time and include cases of complete response (CR) and partial response (PR). Calculated as: (CR cases + PR cases) / FAS × 100 (%); FAS (full analysis set) refers to the case of qualified patients, administered more than one case.
Tumor remission rates are calculated according to the RECIST guidelines (version 1.1)
Measured: Up to 1 year after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start16 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Metastatic to LiverStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiang Long
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiang Long, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531278
- Sponsor's protocol ID
- MR-31-24-025345
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety
- ClinicalTrials.gov ID
- NCT06531278
- Acronym / sponsor ID
- MR-31-24-025345
- Conditions
- Pancreatic Cancer Metastatic to Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiang LongUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jul 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.
- Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer
- Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis
Detailed description
Pancreatic cancer is a cancer of the digestive system with a very high degree of malignancy and a very poor prognosis. In recent years, morbidity and death. The rate shows a clear upward trend at home and abroad. Global cancer statistics in 2020 show that there are new pancreas cases worldwide each year. There are about 495,000 cases of adenocarcinoma and about 466,000 deaths from pancreatic cancer each year. Statistical tables for 2020. In the United States, there are about 57,600 new cases of pancreatic cancer every year, and about 47,050 deaths due to pancreatic cancer each year. Data from pancreatic cancer collected by the National Cancer Center of China in 2019. show that the incidence of pancreatic cancer in Chinese is:6.92 per 100,000, with new cases accounting for about 4.31% of all malignant tumors; The case fatality rate is 6.16 per 100,000 and deaths per year Cases account for about 3.78% of all malignancies. The specific etiology and pathogenesis of pancreatic cancer are unclear, and most (85%). It is an adenocarcinoma originating from the ductal epithelium. Early symptoms are atypical, and most patients are diagnosed locally advanced or out. Now distant metastasis. In the past decade, the first-line treatment regimen for pancreatic cancer has been AG, FOLFIRINOX, GS as the commonly used chemotherapy regimens, and the median OS was 8.5 months, 11.1 months, and 10.1 months, respectively. First-line treatment for pancreatic cancer still needs to be explored. The advent of plastid Iriconia has changed the landscape of first-line treatments, and the NAPOLI-3 study compared NALIRINOX (liposome irinotecan, oxaliplatin, fluorouracil, leucovorin) and AG regimens in the first-line treatment of metastatic pancreatic cancer and safety, with a median follow-up of 16.1 months, showed that the median OS of NALIRINOX versus AG was respectively 11.1 versus 9.2 months (HR 0.83 [95% CI 0.70-0.99]; p=0.036), and the median PFS was 7.4 vs. 5.6, respectively months (HR 0.69 [0.58-0.83]; p<0.0001), the ORR was 42% and 36%, respectively. Based on this research The FDA approved liposomal irinotecan in combination with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreas Indications for adenocarcinoma.
Jiangsu Hengrui Pharmaceutical Co., Ltd. developed irinotecan hydrochloride liposome injection (HR070803) has both protection Protective, long-term cyclic and passively targeted. HR070803 combination with 5-FU/LV for second-line treatment of locally advanced or metastatic pancreas after failure of gemcitabine therapy Adenocarcinoma. Significantly prolonged the subject's OS compared to placebo in combination with 5-FU/LV, with a clinically meaningful difference, Significantly lower risk of death. In addition, HR070803 in combination with 5-FU/LV may also prolong the subject's PFS and TTF, and improve ORR and CA19-9 response rates. At the same time, HR070803 combined with 5-FU/LV in advanced pancreas. The type of AE observed in the treatment of adenocarcinoma is consistent with that of regular irinotecan, and there are gastrointestinal reactions, hematotoxic. It is less sexual, well tolerated, and safe and controllable.
Based on the above evidence, this study explored the efficacy and safety of adebelimab, irinotecan liposome, oxaliplatin, fluorouracil, and leucovorin in the first-line treatment of advanced metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| first-line treatment of pancreatic cancer liver metastasis efficacy and safety | Experimental | Drug: Irinotecan liposome, Drug: Adebrelimab, Drug: Oxaliplatin, Drug: Fluorouracil, Drug: Calcium folinateAdebelimab combined with irinotecan liposomal injection, oxaliplatin, Fluorouracil and calcium folinate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients voluntarily join this study and sign the informed consent form
- Age: 18-75 years old (inclusive), male or female
- Histologically confirmed pancreatic cancer liver metastases and no previous treatment of any systemic anti-swelling tumor treatment
- No central nervous system metastases
- No adjuvant therapy within 6 months prior to enrollment
Key exclusion criteria (10 listed)
- Other active malignancies within 5 years or concomitantly
- Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) in accordance with: New York Heart Association (NYHA) criteria grade II or greater cardiac insufficiency or Cardiac ultrasonography: LVEF (left ventricular ejection fraction) <50%; (2) Instability Stereotyped angina; (3) Myocardial infarction within 1 year prior to the start of study treatment Die; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention: (5) QTc>450ms (male); QTc>470ms (Women) (The QTc interval is calculated by Fridericia's formula; If the QTc is abnormal, interval can be used Approximately 2 minutes for three consecutive tests, taking the average);
- Those who have high blood pressure and cannot be reduced to the normal range by antihypertensive drug treatment (admitted Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (based on 2 measurements of ≥ The mean of the BP readings obtained), which is allowed to be achieved through the use of antihypertensive therapy above parameters
- Coagulation abnormalities (INR>1.5×ULN, APTT>1.5×ULN), with: Bleeding tendency
- Active bleeding
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* Patients are planned to receive irinotecan liposomal (60 mg/m2; d1) of every cycle. * 27 days a cycle | Drug | first-line treatment of pancreatic cancer liver metastasis efficacy and safety |
| Adebrelimab* Patients are planned to receive Adebrelimab (20 mg/kg; d1) of every cycle. * 27 days a cycle | Drug | first-line treatment of pancreatic cancer liver metastasis efficacy and safety |
| Oxaliplatin* Patients are planned to receive Oxaliplatin (85 mg/m2; d1) of every cycle. * 27 days a cycle | Drug | first-line treatment of pancreatic cancer liver metastasis efficacy and safety |
| Fluorouracil* Patients are planned to receive fluorouracil (2400mg/m2; d1) of every cycle. * 27 days a cycle | Drug | first-line treatment of pancreatic cancer liver metastasis efficacy and safety |
| Calcium folinate* Patients are planned to receive Calcium folinate (400mg/m2; d1) of every cycle. * 27 days a cycle | Drug | first-line treatment of pancreatic cancer liver metastasis efficacy and safety |
Primary outcome
ORR
Time frame: Up to 1 year after the treatment
The proportion of patients whose tumors shrink to a certain amount for a certain period of time and include cases of complete response (CR) and partial response (PR). Calculated as: (CR cases + PR cases) / FAS × 100 (%); FAS (full analysis set) refers to the case of qualified patients, administered more than one case. Tumor remission rates are calculated according to the RECIST guidelines (version 1.1)
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 31 Jul 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.
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 Irinotecan liposome, Adebrelimab and Oxaliplatin in people with Pancreatic Cancer Metastatic to Liver, run by Jiang Long 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 10 inclusion and 10 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 31 Jul 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?
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 Long Jiang, MD (18017317460, jiang.long@shgh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Up to 1 year after the treatment). 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 31 Jul 2024.