Adebrelimab in Combination With NALIRIFOX in Locally Advanced Pancreatic Cancer

NCT06475326 | Recruiting Phase 2

• 1 other identifier: CSPAC-29
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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 therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (4)

• Pathologic response rate (pCR/MPR)

  up to approximately 1 years

• Objective response rate (ORR)

  up to approximately 1 years

• Event-free survival (EFS)

  up to approximately 1 years

• Overall survival (OS)

  up to approximately 1 years

Study Arms (1)

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)

Drug: Adebrelimab; Drug: Oxaliplatin 100 MG; Drug: Irinotecan liposome; Drug: Calcium Folinate; Drug: Fluorouracil

Interventions

Adebrelimab DRUG

Adebrelimab ,20mg/Kg per time, Q4W

Also known as: PD-L1

Adebrelimab Combined with NALIRIFOX

Oxaliplatin 100 MG DRUG

Oxaliplatin: 60mg/m2, Q2W

Adebrelimab Combined with NALIRIFOX

Irinotecan liposome DRUG

Irinotecan Liposome: 50mg/m2, Q2W

Adebrelimab Combined with NALIRIFOX

Calcium Folinate DRUG

Calcium Folinate: 400mg/m2, Q2W

Also known as: LV

Adebrelimab Combined with NALIRIFOX

Fluorouracil DRUG

Fluorouracil: 2400mg/m2, Q2W

Adebrelimab Combined with NALIRIFOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; irinotecan sucrosofate; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Weijing Zhang

  Fudan University

  STUDY CHAIR

Central Study Contacts

Si Shi, PHD

CONTACT

+86-021-64179375; shisi@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 5, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)