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NCT Number: NCT06571461

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

liposomal irinotecan

Drug

Liposomal Irinotecan：i.v. infusion

Oxaliplatin

Drug

Oxaliplatin;：i.v. infusion

S-1

Drug

S-1: Oral

Gemcitabine

Drug

Gemcitabine: i.v. infusion

Capecitabine

Drug

Capecitabine: Oral

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: Approximately 3 years.

    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.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Approximately 5 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group officer

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Aug 26, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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