Combining Adebrelimab with NALIRIFOX for advanced pancreatic cancer treatment

A Phase II Trial of Adebrelimab in Combination With NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer

This study is testing if combining a new immunotherapy called Adebrelimab with a chemotherapy treatment called NALIRIFOX can help people with advanced pancreatic cancer turn their tumors into ones that can be surgically removed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, Adebrelimab, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06475326 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of combining Adebrelimab, an immunotherapy, with NALIRIFOX, a chemotherapy regimen, in patients with locally advanced pancreatic cancer. The approach aims to convert unresectable tumors into resectable ones through a combination of therapies, followed by various treatment options such as surgery and advanced systemic therapy based on individual patient responses. Key outcomes include surgical resection rates, changes in tumor markers, and overall survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed unresectable locally advanced pancreatic ductal adenocarcinoma who have not received prior treatment.

Not a fit: Patients with resectable pancreatic cancer or those who have previously undergone treatment for pancreatic cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with locally advanced pancreatic cancer.

How similar studies have performed: While the combination of immunotherapy and chemotherapy is a novel approach in this specific context, similar strategies have shown promise in other cancer types.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years old;
2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (preferably histologically confirmed);
3. Judged by the investigator to be unresectable locally advanced (unresectable criteria refer to the guidelines for the diagnosis and treatment of pancreatic cancer);
4. Total bilirubin ≤ 2 mg/dL (subjects with bile duct stents can be enrolled if bilirubin ≤ 2 mg/dL and no cholangitis after stent placement);
5. Have not received previous treatment for pancreatic cancer, including radiotherapy, chemotherapy, surgery, etc;
6. 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.
7. 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.

Exclusion Criteria:

1. Occurrence of distant metastases (for imaging suspicion of peritoneal cancer or ascites, histological or cytological verification such as laparoscopic exploration is required)
2. 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
3. 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).
4. 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
5. 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.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Si Shi, PHD

Conditions Pancreatic Cancer