Pancreatic CancerPhase 1NCT05083780
Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer
A Phase 1 study testing Chlorphenesin Carbamate, Hydroxychloroquine in people with Pancreatic Cancer, run by Changhoon Yoo at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Chlorphenesin Carbamate, Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2021to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Chlorphenesin Carbamate, Hydroxychloroquine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorphenesin Carbamate, HydroxychloroquineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine | Experimental | Not described Receives: Drug: Chlorphenesin Carbamate, Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events assessed by CTCAE v5.0
Measured: up to 3 years
Secondary outcomes (4)
Rate of Progression-Free Survival
Measured: 6, 12 months
Rate of Distant Metastasis-Free Survival
Measured: 6, 12 months
Overall Survival
Time between study treatment and death
Measured: up to 3 years
Objective Response Rate
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start30 Nov 2021
- Primary completion28 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhoon Yoo
- Sponsor type
- University, hospital or other
- Collaborators
- Oncocross Co. Ltd., CytoGen, Inc.
- Responsible party
- Sponsor-investigator, Changhoon Yoo, Asan Medical Center
- Investigators
- Changhoon Yoo, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083780
- Sponsor's protocol ID
- OC-201/202-001
- Status last verified
- Apr 2025
- First submitted
- 6 Oct 2021
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Inoperable Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05083780
- Acronym / sponsor ID
- OC-201/202-001
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Changhoon YooUniversity, hospital or other
- Collaborators
- Oncocross Co. Ltd., CytoGen, Inc.
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 28 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine | Experimental | Drug: Chlorphenesin Carbamate, Hydroxychloroquine |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorphenesin Carbamate, HydroxychloroquineIn 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. | Drug | mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine |
Primary outcome
Number of participants with treatment-related adverse events assessed by CTCAE v5.0
Time frame: up to 3 years
4 secondary outcomes
Rate of Progression-Free Survival
Time frame: 6, 12 months
Rate of Distant Metastasis-Free Survival
Time frame: 6, 12 months
Overall Survival
Time frame: up to 3 years
Objective Response Rate
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changhoon Yoo, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chlorphenesin Carbamate, Hydroxychloroquine in people with Pancreatic Cancer, run by Changhoon Yoo at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events assessed by CTCAE v5.0 (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.