Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

NCT ID: NCT05083780

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2026-12-30

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine

Group Type: EXPERIMENTAL

Chlorphenesin Carbamate, Hydroxychloroquine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncocross Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

CytoGen, Inc.

INDUSTRY

Sponsor Role: collaborator

Changhoon Yoo

OTHER

Sponsor Role: lead

Responsible Party

Changhoon Yoo

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Changhoon Yoo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

OC-201/202-001

Identifier Type: -

Identifier Source: org_study_id