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NCT Number: NCT05083780

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults of age ≥ 19 and < 80 years
  • 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
  • One or more measurable lesions by RECIST v 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 pr 1
  • Estimated life expectancy of at least 12 weeks or more at the discretion of the investigator

Exclusion criteria

  • History of major surgery within 4 weeks at the time of screening
  • Symptomatic, uncontrolled brain metastasis or meningeal carcinomatosis
  • History of malignancy within 5 years at the time of screening
  • History of human immunodeficiency virus (HIV) or active hepatitis
  • Active infection requiring systemic antibiotic therapy
  • Patients who have maculopathy or are receiving treatment for corneal or retinal disease, or under follow-up
  • 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
  • Serious neurological, psychiatric condition including drug abuse or alcoholism, which would prevent the subject from participating in the study
  • Patients with any condition who are considered unsuitable for participation in the study in the judgment of the investigator

Treatment and study plan

Chlorphenesin Carbamate, Hydroxychloroquine

Drug

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 outcomes

  1. Number of participants with treatment-related adverse events assessed by CTCAE v5.0

    Time frame: up to 3 years

Secondary outcomes

  1. Rate of Progression-Free Survival

    Time frame: 6, 12 months

  2. Rate of Distant Metastasis-Free Survival

    Time frame: 6, 12 months

  3. Overall Survival

    Time frame: up to 3 years

    Time between study treatment and death

  4. Objective Response Rate

    Time frame: up to 3 years

Sponsors and collaborators

Lead sponsor

Changhoon Yoo

Other

Collaborators

  • CytoGen, Inc.
  • Oncocross Co. Ltd.

Registry information

Official study title

A Study of Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Inoperable Locally Advanced or Metastatic Pancreatic Cancer

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Oct 19, 2021
Registry last updated
Apr 16, 2025

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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