Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer

NCT06571461 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HE072-006
• Study Type: interventional
• Target: 408
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Disease-free survival is defined as the time from the date of randomization to the date of disease recurrence or death from any cause (whichever occurs first). Disease recurrence is defined as evidence of disease recurrence demonstrated by imaging assessment with CT or MRI scan and/or pathological diagnosis indicated by biopsy.

  Approximately 3 years.

Secondary Outcomes (1)

• Overall survival (OS)

  Approximately 5 years.

Study Arms (2)

NASOX：Liposomal Irinotecan; Oxaliplatin; S-1

EXPERIMENTAL

Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles.

Drug: Liposomal Irinotecan; Drug: Oxaliplatin; Drug: S-1

GX：Gemcitabine; Capecitabine

ACTIVE COMPARATOR

Gemcitabine at a dose of 1000mg/m² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg/m² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles.

Drug: Gemcitabine; Drug: Capecitabine

Interventions

Liposomal Irinotecan DRUG

Liposomal Irinotecan：i.v. infusion

NASOX：Liposomal Irinotecan; Oxaliplatin; S-1

Oxaliplatin DRUG

Oxaliplatin;：i.v. infusion

NASOX：Liposomal Irinotecan; Oxaliplatin; S-1

S-1 DRUG

S-1: Oral

NASOX：Liposomal Irinotecan; Oxaliplatin; S-1

Gemcitabine DRUG

Gemcitabine: i.v. infusion

GX：Gemcitabine; Capecitabine

Capecitabine DRUG

Capecitabine: Oral

GX：Gemcitabine; Capecitabine

Eligibility Criteria

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

You may qualify if:

• Patients able and willing to provide a written informed consent aged 18-75 years.
• Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
• Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
• Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• The main organs function well.

You may not qualify if:

• Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
• Macroscopic incomplete tumor removal (R2 resection).
• Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
• Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
• CA 19-9\> 180 U / ml within 21 days before randomization.
• The toxicity of previous therapy has not recovered to Grade 1 or below.
• Known peripheral neuropathy (CTCAE ≥ Grade 2).
• Known deficiency of dihydropyrimidine dehydrogenase (DPD)
• Subjects with a confirmed diagnosis of Gilbert's syndrome

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofate; Oxaliplatin; S 1 (combination); Gemcitabine; Capecitabine

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; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a phase III, two-arm, open-label, multi-center, randomized clinical trial comparing combination liposomal irinotecan, oxaliplatin and S-1 with gemcitabine + capecitabine when used as adjuvant therapy following resection for pancreatic ductal adenocarcinoma.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 27, 2024

Record last verified: 2024-08