Adebrelimab Combined With Irinotecan Liposomal (II), Oxaliplatin, and 5-FU/LV Conversion Therapy for Locally Advanced Pancreatic Cancer

NCT06766019 | Active Not Recruiting Phase 2

• 1 other identifier: PC-IIT-003
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a prospective, single-arm, single-center, phase II clinical study, mainly targeting subjects with locally advanced pancreatic cancer, to explore the efficacy and safety of adebrelimab combined with irinotecan liposome (II), oxaliplatin, and 5-FU/LV conversion in the treatment of locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

Locally advanced pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Surgical conversion rate

  Refers to the proportion of subjects with successful conversion to all subjects receiving conversion therapy. Achievement of R0/R1 resection after conversion therapy was defined as successful conversion.

  Up to 6 months

Secondary Outcomes (7)

• Overall Survival (OS)

  5 years

• 1-year OS rate

  1 year

• Objective response rate (ORR)

  Up to 3 years

• Event-free survival (EFS)

  Up to 3 years

• Disease Control Rate (DCR)

  Up to 3 years

Other Outcomes (2)

• Treatment-related adverse events

  Up to 3 years

• CA19-9 Response Rate

  Up to 3 years

Study Arms (1)

Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV

EXPERIMENTAL

Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV

Drug: Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV

Interventions

Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV DRUG

1. adebrelimab 1200mg, i.v. D1, q28d 2. irinotecan liposomal (II) 60mg/m\^2, i.v. D1, Q2W 3. oxaliplatin 85mg/m\^2, i.v. D1, Q2W 4. 5-FU/LV 2400mg/400mg/m\^2, i.v. D1, Q2W 4-week cycles, 6 cycles

Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written informed consent before implementing any trial-related procedures;
• Age ≥ 18 years old and ≤ 70 years old, regardless of gender;
• Locally advanced pancreatic cancer confirmed by histopathological/cytopathological examination;
• Patients with locally advanced stage and no previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.);
• Definition of locally advanced pancreatic cancer:
• The tumor has no distant metastasis;
• Pancreatic head/uncinate process: the tumor contacts the superior mesenteric artery \> 180 ˚;
• Body and tail of pancreas: the tumor contacts the superior mesenteric artery or trunk celiac artery \> 180 ˚; The tumor contacted the celiac trunk artery and infiltrated the abdominal aorta;
• The tumor invaded the jejunal branch of the superior mesenteric artery. The portal vein-superior mesenteric vein cannot be safely reconstructed due to tumor invasion, venous occlusion or involvement of a large area of the jejunal branch of the superior mesenteric vein;
• According to the efficacy evaluation criteria of solid tumors (RECIST version 1.1) with at least one radiographically measurable lesion;
• ECOG score 0-1;
• If the biliary obstruction needs to be lifted, the expected survival time is \> 3 months;
• Sufficient organ function, subjects must meet the following laboratory indicators:
• Absolute neutrophil value (ANC) ≥ 1.5 × 109/L in the absence of granulocyte colony-stimulating factor in the past 14 days;
• platelets ≥ 100 × 109/L in the absence of blood transfusion in the past 14 days;

You may not qualify if:

• Subjects who meet any of the following criteria will not be allowed to enter the study:
• Patients with portal hypertension or cavernous degeneration of portal vein; Patients with gastrointestinal bleeding caused by tumors that have involved the gastrointestinal tract; Patients with tumor involvement of digestive tract causing intra-abdominal fistula or abscess; The tumor surrounds the celiac trunk or superior mesenteric artery (SMA) and causes significant involvement of the vascular wall (worm-like changes); Presence of distant metastatic lesions;
• There is a third space effusion that cannot be controlled by drainage or other methods (such as medium-massive pleural effusion, medium-massive pericardial effusion, ascites); A small amount of pleural effusion or ascites that has no clinical symptoms and does not require clinical intervention should be strictly controlled before enrollment;
• Those with poor compliance and inability to cooperate and describe treatment responses;
• Other malignant diseases other than pancreatic cancer diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ);
• Currently participating in interventional clinical study treatment, or received other study drugs or treatment with study devices within 4 weeks prior to the first dose;
• Have previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs directed at another stimulation or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137);
• Have received systemic systemic treatment with ready-for-use traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications (including thymosin, interferon, interleukin, except for local use to control ascites) within 2 weeks before the first dose;
• Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g. thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy;
• Were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiological doses of glucocorticoids (≤ 10 mg/d of prednisone or equivalent) are allowed;
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• Those who are known to be allergic to the active ingredients or excipients of the study drug adebelimab, leucovorin, 5-fluorouracil, irinotecan and oxaliplatin;
• People who are addicted to bad drugs such as drug abuse, long-term alcoholics, and people with infectious diseases such as AIDS (i.e. HIV 1/2 antibody positive);
• Uncontrolled active hepatitis B (defined as HBsAg positive and detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the study center);
• Note: Subjects with hepatitis B who meet the following criteria can also be enrolled:

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 025, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofate; Oxaliplatin

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: October 16, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)