Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Chlorphenesin Carbamate, Hydroxychloroquine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events assessed by CTCAE v5.0	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Progression-Free Survival		6, 12 months
Rate of Distant Metastasis-Free Survival		6, 12 months
Overall Survival	Time between study treatment and death	up to 3 years
Objective Response Rate		up to 3 years

Collaborators and Investigators

• Sponsor: Changhoon Yoo
• Collaborators: Oncocross Co. Ltd.; CytoGen, Inc.
• Investigators: Principal Investigator: Changhoon Yoo, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Estimated): December 28, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 12, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Neuromuscular Agents; Muscle Relaxants, Central; Hydroxychloroquine; Chlorphenesin
• Other Study ID Numbers: OC-201/202-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No