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Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer


2021-11-30


2025-12-28


2026-12-30


40

Study Overview

Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

Pancreatic cancer is the 8th most prevalent cancer in Korea, and its 5-year overall survival rate has shown less than 10% due to its dismal prognosis. To date, the only curative treatment of pancreatic cancer is surgical resection. However, about 60% of patients with pancreatic cancer have been diagnosed as a locally advanced unresectable or metastatic disease at diagnosis owning to its difficulty in the early detection of cancer. The 5-year survival rate has been reported to be less than 25% even with surgical resection. Considering the high rate of metastasis and recurrence, systemic chemotherapy is essential to prolong survival. Therefore, Using AI platforms of RAPTOR (RNA expression-based Anti-symmetrical Pairing Tool for On-demand Response) and ReDRUG (Restoration using the drug for targeting unbalanced gene) developed by Oncocross, Chlorphenesin carbamate, and Hydroxychloroquine were discovered as candidate drugs having anti-metastatic effects. This study aimed to evaluate the efficacy and safety of hydroxychloroquine and chlorphenesin carbamate in combination with mFOLFIRINOX in patients with inoperable locally advanced or metastatic pancreatic cancer.

N/A

  • Pancreatic Cancer
  • DRUG: Chlorphenesin Carbamate, Hydroxychloroquine
  • OC-201/202-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-10-06  

N/A  

2025-04-12  

2021-10-18  

N/A  

2025-04-16  

2021-10-19  

N/A  

2025-04  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine

DRUG: Chlorphenesin Carbamate, Hydroxychloroquine

  • In addition to the mFOLFIRINOX therapy(backbone therapy), chlorphenesin carbamate 250 mg, and hydroxychloroquine 200 mg will be administered orally twice daily for up to 48 weeks.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of participants with treatment-related adverse events assessed by CTCAE v5.0up to 3 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Rate of Progression-Free Survival6, 12 months
Rate of Distant Metastasis-Free Survival6, 12 months
Overall SurvivalTime between study treatment and deathup to 3 years
Objective Response Rateup to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Adults of age ≥ 19 and < 80 years 2. A patient who meets any of the following criteria at the time of screening or before, and who is scheduled to receive chemotherapy with modified FOLFIRINOX for the first time after screening

  • Locally advanced inoperable pancreatic cancer
  • Metastatic pancreatic cancer 3. One or more measurable lesions by RECIST v 1.1 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 pr 1 5. Estimated life expectancy of at least 12 weeks or more at the discretion of the investigator

  • Exclusion Criteria:
    1. History of major surgery within 4 weeks at the time of screening 2. Symptomatic, uncontrolled brain metastasis or meningeal carcinomatosis 3. History of malignancy within 5 years at the time of screening 4. History of human immunodeficiency virus (HIV) or active hepatitis 5. Active infection requiring systemic antibiotic therapy 6. Patients who have maculopathy or are receiving treatment for corneal or retinal disease, or under follow-up 7. History of acute or subacute intestinal obstruction or paralytic ileus, or a history of chronic diarrhea considered clinically significant at the discretion of the investigator 8. Serious neurological, psychiatric condition including drug abuse or alcoholism, which would prevent the subject from participating in the study 9. Patients with any condition who are considered unsuitable for participation in the study in the judgment of the investigator

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Oncocross Co. Ltd.
  • CytoGen, Inc.

  • PRINCIPAL_INVESTIGATOR: Changhoon Yoo, MD, PhD, Asan Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available