ClinicalTrials.gg
RecruitingNCT06531278Updated Jul 31, 2024

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 interventional study of Irinotecan liposome and Adebrelimab in Pancreatic Cancer Metastatic to Liver, sponsored by Jiang Long. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Jiang Long · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pancreatic Cancer Metastatic to Liver
03

In context

Lead sponsor

This is the only study on the registry with Jiang Long as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients voluntarily join this study and sign the informed consent form
  2. Age: 18-75 years old (inclusive), male or female
  3. Histologically confirmed pancreatic cancer liver metastases and no previous treatment of any systemic anti-swelling tumor treatment
  4. No central nervous system metastases
  5. No adjuvant therapy within 6 months prior to enrollment
  6. ECOG PS: 0\~1 points
  7. Estimated survival ≥ 12 weeks
  8. 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);
  9. 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
  10. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Other active malignancies within 5 years or concomitantly
  2. 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);
  3. 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
  4. Coagulation abnormalities (INR>1.5×ULN, APTT>1.5×ULN), with: Bleeding tendency
  5. Active bleeding
  6. Uncontrolled active infection, chronic infectious disease, immunodeficiency syndrome
  7. Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥10 3 copy number or ≥1000 U/ml)
  8. Presence of active autoimmune disease or history of autoimmune disease with possible recurrence 9. Known history of severe allergy to the study drug
  9. Uncontrolled infection at screening
  10. Other patients who are considered by the treating physician to be unsuitable for inclusion
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    first-line treatment of pancreatic cancer liver metastasis efficacy and safety

    Adebelimab combined with irinotecan liposomal injection, oxaliplatin, Fluorouracil and calcium folinate

    Drug: Irinotecan liposome · Drug: Adebrelimab · Drug: Oxaliplatin · Drug: Fluorouracil · Drug: Calcium folinate

Interventions

  • * Patients are planned to receive irinotecan liposomal (60 mg/m2; d1) of every cycle. * 27 days a cycle

  • * Patients are planned to receive Adebrelimab (20 mg/kg; d1) of every cycle. * 27 days a cycle

  • * Patients are planned to receive Oxaliplatin (85 mg/m2; d1) of every cycle. * 27 days a cycle

  • * Patients are planned to receive fluorouracil (2400mg/m2; d1) of every cycle. * 27 days a cycle

  • * Patients are planned to receive Calcium folinate (400mg/m2; d1) of every cycle. * 27 days a cycle

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Up to 1 year after the treatment

07

Study locations

1 of 1 sites recruiting
  • Shanghai General Hospital
    Shanghai, Shanghai Municipality 200040, China
    • Jiang Long, MD · Contact · jiang.long@shgh.cn · +86 18017317460
    • Jiang Long, MD · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2024
First posted
Jul 31, 2024
StartActual
Jul 16, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06531278
Lead sponsor
Jiang Long
Responsible party
Jiang Long (Chief physician of hepatobiliary and pancreatic surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
Jul 31, 2024
Start date
Jul 16, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 31, 2024

Study contacts

Long Jiang, MD
Contact
jiang.long@shgh.cn
18017317460

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Oxaliplatin · Fluorouracil · Leucovorin

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