NCT05083780Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 16 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 6 Oct 2021
- Start date
- 30 Nov 2021
- Primary completion date
- 28 Dec 2025
- Lead sponsor
- Changhoon Yoo
- Diseases
- Pancreatic cancer
- NCT number
- NCT05083780
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 40
- From 30 Nov 2021 to the primary completion date, 28 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have maculopathy or are receiving treatment for corneal or retinal disease, or under follow-up
Other illness
- History of major surgery within 4 weeks at the time of screening
- 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
- 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
Other
- Symptomatic, uncontrolled brain metastasis or meningeal carcinomatosis
Who the study is looking for
- 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
Age in the registry: 19 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.