Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Chlorphenesin Carbamate, Hydroxychloroquine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine<br> | Drug: Chlorphenesin Carbamate, Hydroxychloroquine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |