The Combination Chemotherapy of SIRIOX as First- or Second-Line Chemotherapy for Pancreatic Cancer

NCT03403101 | Unknown Phase 2

• 1 other identifier: CSPAC-020
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

Pancreatic cancer represents the most lethal of the common malignancies with a 5-year survival rate of less than 5%. For patients who are eligible for potentially curative resection, despite mortality and morbidity rates after surgery have improved, the recurrence rate is up to 85% within 2 years. FOLFIRINOX (fluoropyrimidine/leucovorin plus irinotecan and oxaliplatin) has been proved to significantly improve the prognosis and is recommended as first line treatment in patients with advanced pancreatic cancer. However, the regimen is limited due to the severe adverse effects. Thus, the investigators replaced 5-FU and leucovorin in the FOLFIRINOX regimen with oral S-1, a new oral fluoropyrimidine derivative which was proved to be the well-tolerated and effectively in large III phase randomized clinical trial, to form the SIRIOX regimen. A phase I clinical trial from Japan found that SOXIRI (S-1, oxaliplatin and irinotecan) works in patients with advanced pancreatic cancer. In this study, the researchers intend to investigate the activity and safety of the combination of this regimen in patients with advanced pancreatic cancer, as first- or second-line chemotherapy.

Conditions

Carcinoma, Pancreatic Ductal

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  The time from the beginning of randomization to the earliest date of confirmation of tumor progression or the patient death for any reason. If the above criteria are not reached, the date of the last evaluation will be used.

  6 weeks (1.5 cycle)

Secondary Outcomes (3)

• objective response rate (ORR)

  6 weeks (1.5 cycle)

• overall survival (OS)

  through study completion, an average of 18 months

• Toxicity evaluated according to the Common Terminology Criteria Adverse Events

  every week

Study Arms (1)

SIRIOX regimen

EXPERIMENTAL

5-FU and leucovorin in the FOLFIRINOX regimen were replaced with oral S-1, forming the SIRIOX regimen(S1 plus irinotecan and oxaliplatin)

Drug: S1; Drug: Oxaliplatin; Drug: Irinotecan

Interventions

S1 DRUG

Patients are planned to receive the SIRIOX regimen including S-1 (BSA \< 1.2m2, 40 mg/day; BSA = 1.2\~1.4 m2, 60 mg/day; BSA = 1.4\~1.6 m2, 80 mg/day; BSA \> 1.6 m2, 100 mg/day; oral twice daily on days 1-7, days 15-21）of every cycle. • 28 days a cycle.

SIRIOX regimen

Oxaliplatin DRUG

Patients are planned to receive the SIRIOX regimen including Oxaliplatin (OXA, 85 mg/m2; d1,d15) of every cycle. • 28 days a cycle

SIRIOX regimen

Irinotecan DRUG

Patients are planned to receive the SIRIOX regimen including Irinotecan (IRI, 180mg/m2; day 1,day 15) of every cycle. • 28 days a cycle

SIRIOX regimen

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 aged 18 - 75 years old at the time of signing the ICF.
• Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant are acceptable without Irinotecan, Oxaliplatin, or S1).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Adequate hematologic function defined as: absolute neutrophil count (ANC) \>= 2,000/μL; platelets count \>= 100,000/μL; hemoglobin must be \>= 10 g/dL (can be corrected by growth factor or transfusion).
• Adequate hepatic function defined as: serum bilirubin =\< 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =\< 3-fold ULN (5-fold ULN if liver metastasis is observed).
• Adequate renal function with: serum creatinine =\< 1.3 mg/dL or calculated creatinine clearance \>= 60 mL/minute according to the Cockcroft and Gault formula.
• At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Life expectancy over 12 weeks.
• Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months.
• Willing and able to comply with all aspects of the treatment protocol.
• Provide written informed consent.

You may not qualify if:

• Patients who are unwilling or unable to comply with the study protocol;
• Existing anticancer treatment-related toxicities of Grades \>= 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).
• Simultaneously using targeted therapies, such as Erlotinib, Nimotuzumab etc;
• Any severe or uncontrolled systemic disease (e.g., unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, hypertension, severe arrhythmia, diabetes mellitus, massive active bleeding);
• Large operations were performed within 14 days before entering the study, or there were surgical incisions that were not completely healed;
• Women who are pregnant or breastfeeding;
• Ascertained hypersensitivity to investigational product, Oxaliplatin, Irinotecan, and S1 or any of the excipients used in the study.
• History of other malignancies within 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ;
• Obvious gastrointestinal injury history, the researchers estimate may significantly affect the absorption of S1 on the whole, including the ability to swallow drugs;
• Other combinations of anticancer therapies (including LHRH agonists, anticancer herbs, immunotherapy), except steroid hormones;
• Patients with UGT1A1 mutations or congenital disease lack of UGT1A1 expression (e.g. Crigler-Najjar syndrome and Gilbert syndrome);
• Patients with DPD enzyme deficiency.
• Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Interventions

S 1 (combination); Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Xianjun Yu, M.D., Ph.D.

  270 Dong An Road, Shanghai 200032, China

  STUDY CHAIR

Central Study Contacts

Xianjun Yu, M.D., Ph.D.

CONTACT

+86 21 64175590; yuxianjun88@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Otolaryngology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: January 18, 2018
• Study Start: July 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

CN (2)