A Phase 1/2 interventional study of High Dose Ascorbic Acid 25 g/m^2 and Nanoparticle Paclitaxel protein bound 125mg/m^2 in Pancreatic Cancer, Pancreas Cancer and Pancreatic Adenocarcinoma Resectable, sponsored by HonorHealth Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by HonorHealth Research Institute · Phase 1/2, Interventional, and Treatment
Among 15 studies testing Ascorbic Acid in Pancreatic Neoplasms — 2 open to participants now, 2 under way, none of them phase 3. Ascorbic Acid · Pancreatic Neoplasms.
Among the 15 studies testing Ascorbic Acid in Pancreatic Neoplasms, this one is the 6th largest by enrollment, is one of 2 that started in 2017, is one of 4 in phase 1/2, and was the 9th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
Browse Pancreatic Neoplasms studies →2 of the 15 studies testing Ascorbic Acid in Pancreatic Neoplasms are open now, in 1 country. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18–80
Zhongnan Hospital · Sites in China
Ages 18–70
By country, each count listing its studies:
Ascorbic Acid: first FDA approval 1947 (BEROCCA PN). What it is approved for, and how studies give it, is on its page →
Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 11
First in 2009; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 14 across the 15 interventional studies. Of the 9 that completed or were terminated, 6 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 15 has an industry lead sponsor. The 10 most frequent:
HonorHealth Research Institute is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
HonorHealth Research Institute has 7 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing Ascorbic Acid in Pancreatic Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to see if a treatment regimen with a combination of paclitaxel protein bound (also known as nab-paclitaxel), gemcitabine, and cisplatin when given with high dose Ascorbic Acid will be safe and effective in individuals with untreated metastatic pancreatic cancer.
Pancreatic cancer continues to be a very lethal disease. It was estimated that in 2016, 53,070 Americans would be diagnosed with pancreatic ductal adenocarcinoma (PDA), and 41,780 would die from the disease. This makes pancreatic cancer the third leading cause of death from cancer in the US.
PDA is the twelfth most common cancer in the world with 338,000 new cases diagnosed in 2012. It is estimated that worldwide there will be > 300,000 deaths from pancreatic cancer. Furthermore unfortunately PDA is projected to be the second leading cause of death from cancer in the US by 2030.
Detection of pancreatic cancer has notoriously been very late in the disease and therefore the 5-year survival rate is only 8%, which is actually a slight improvement over the last few years. Right now the only potential cure for pancreatic cancer is surgical resection (if the disease is caught early). However only about 20% of PDA patients are eligible for potentially curable resection and unfortunately most (> 80%) have recurrence of their cancer within 2 years of resection, and those recurrences are almost universally fatal.
Recently it has been shown that there are regimens that actually improve survival for patients with advanced stage IV PDA. Conroy and colleagues have developed the Folfirinox regimen, which in a large randomized trial improved survival over gemcitabine as a single agent. Von Hoff and colleagues developed the nanoparticle albumin (nab) associated paclitaxel plus gemcitabine regimen which improved survival over single agent gemcitabine. Even more recently Jameson and colleagues have presented a combined regimen of nab-paclitaxel + gemcitabine + cisplatin in a small 24 patient phase Ib/II trial which showed a response rate of 71% with 2 patients having complete response, a 1-year survival of 65% and a median survival of 16+ months.
While there have been multiple investigators and investigations into the use of ascorbic acid for patients with cancer (see ClinTrials.gov), its use has generally not been found to be of help for patients particularly when given orally - e.g. 10 grams daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet the following criteria to be included in the trial:
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
Exclusion Criteria:
Patients must not meet any of the following criteria in order to be eligible for the trial:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
25 grams/m\^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 \& 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Drug: High Dose Ascorbic Acid 25 g/m^2 · Drug: Nanoparticle Paclitaxel protein bound 125mg/m^2 · Drug: Cisplatin 25mg/m^2 · Drug: Gemcitabine 1000mg/m^2
37.5 g/m\^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 \& 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Drug: Nanoparticle Paclitaxel protein bound 125mg/m^2 · Drug: Cisplatin 25mg/m^2 · Drug: Gemcitabine 1000mg/m^2 · Drug: High Dose Ascorbic Acid 37.5 g/m^2
56.25 g/m\^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 \& 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Drug: Nanoparticle Paclitaxel protein bound 125mg/m^2 · Drug: Cisplatin 25mg/m^2 · Drug: Gemcitabine 1000mg/m^2 · Drug: High Dose Ascorbic Acid 56.25 g/m^2
75 g/m\^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 \& 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Drug: Nanoparticle Paclitaxel protein bound 125mg/m^2 · Drug: Cisplatin 25mg/m^2 · Drug: Gemcitabine 1000mg/m^2 · Drug: High Dose Ascorbic Acid 75 g/m^2
Drug page: Ascorbic Acid
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Also known as: AA
Drug page: Albumin-Bound Paclitaxel
30 minute IV infusions on days 1 and 8 repeated every 21 days
Also known as: Abraxane
Drug page: Cisplatin
Via 500mL of Normal Saline over 60 minute IV infusion on days 1 and 8 repeated every 21 days
Also known as: Platinol
Drug page: Gemcitabine
Via 500mL of Normal Saline over 30 minute IV infusion on days 1 and 8 repeated every 21 days
Also known as: Gemzar
Drug page: Ascorbic Acid
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Also known as: AA
Drug page: Ascorbic Acid
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Also known as: AA
Drug page: Ascorbic Acid
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Also known as: AA
Total Dose Received [Identifying Recommended Maximum Tolerated Dose (MTD)]
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the total dose received of ascorbic acid (g/m\^2) by participants was measured.
Time frame: From enrollment through end of treatment, up to 40 weeks
Duration of Dose in Days [Identifying Recommended Maximum Tolerated Dose (MTD)]
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the duration of ascorbic acid dose in days is reported.
Time frame: From enrollment through end of treatment, up to 40 weeks
Duration of Dose in Weeks [Identifying Recommended Maximum Tolerated Dose (MTD)]
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the duration of ascorbic acid dose in weeks is reported.
Time frame: From enrollment through end of treatment, up to 40 weeks
Disease Control Rate (CR+PR+SD at 18 Weeks)
Preliminary efficacy as measured by disease control rate (DCR), defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) at 18 weeks according to RECIST v1.1. CR = disappearance of all target lesions; PR = at least 30% decrease in sum of the longest diameters for target lesions, SD = insufficient change to qualify for PR or progressive disease \[defined as at least 20% increase in sum of the longest diameters for target lesions\].
Time frame: 18 weeks
Best Overall Response
Best overall response according to RECIST v1.1. Complete response (CR) = disappearance of all target lesions; Partial response (PD) = at least 30% decrease in sum of the longest diameters for target lesions; Stable disease (SD) = insufficient change to qualify for PR or PD; Progressive disease (PD) = at least 20% increase in sum of the longest diameters for target lesions.
Time frame: From enrollment through end of treatment, up to 36 weeks
Incidence of Toxicities
Incidence of adverse events reported according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: From enrollment through 30 days after the end of treatment, up to 40 weeks
Normalization of Tumor Markers by AA Treatment Group
The percentage of patients who had elevated levels of tumor marker CA 19-9 (or CA-125/CEA if not expressors of CA 19-9) and had their levels normalize. Elevated levels were defined as any value \>35 U/mL for CA 19-9, \>35 U/mL for CA-125, and \>3 ng/mL for CEA. Normalization was defined as any patient who had elevated tumor marker values at baseline and decreased to CA 19-9 value of 0.0-35 U/mL, CA-125 value of 0.0-35 U/mL, or CEA value of 0.0-3 ng/mL during treatment.
Time frame: From enrollment through study completion, up to 40 weeks
Overall Survival
Telephone follow-up conducted every 12 weeks from the last dose of treatment to determine survival status.
Time frame: Approximately 12 weeks from last study treatment, assessed up to 3 years
Progression-free Survival
Telephone follow-up conducted every 12 weeks from the last dose of treatment to determine status of disease progression.
Time frame: Approximately 12 weeks from last study treatment, assessed up to 3 years
Quality of Life: MD Anderson's Symptom Inventory-GI (MDASI-GI)
Changes in patient's self-reported quality of life as determined by administering the MD Anderson Symptom Inventory (MDASI-GI). This questionnaire asks patients to rank the severity of symptoms using a 0-10 scale (0 = not present to 10 = as bad as you can imagine) and averages the responses of 18 questions to produce an MDASI-GI score on a 0-10 scale. MDASI-GI scores measured at the start of Cycle 1 and at the end of treatment (EOT) are reported here.
Time frame: From Cycle 1 to end of treatment, up to 40 weeks
Quality of Life: Brief Pain Inventory (BPI) - Pain Intensity (PI)
Changes in patient's self-reported pain levels determined by administering the Brief Pain Inventory (BPI) - Pain Intensity (PI) assessment. This questionnaire asks about pain intensity using a 0-10 scale (0 = not present to 10 = as bad as you can imagine) and averages the responses of 4 questions to output a BPI-PI score on a 0-10 scale. BPI-PI scores measured at the start of Cycle 1 and at the end of treatment (EOT) are reported here.
Time frame: From start of Cycle 1 to end of treatment, up to 40 weeks
Tumor Texture on Radiologic Scans
Imaging completed to evaluate tumor texture on radiologic scans as a non-invasive imaging biomarker for response, biologic, pathologic and outcome measures.
Time frame: approximately 63 days
Correlation Between Peak Plasma Concentration of Ascorbic Acid and Response to Treatment
Lab testing will be completed to evaluate the correlation between peak plasma concentration of ascorbic acid and response to treatment
Time frame: approximately 63 days
Potential Tumor Biomarkers
Tumor biopsy testing will be completed to evaluate potential biomarkers in the tumor including tumor immune cell infiltration, stromal activation, stem cell enumeration, metabolic profiles, whole exome and whole genome CN, ChIP-seq/ATAQ seq, IHC and PCR assays on immune cell populations, CAFs, stem cell content (CD133, Aldh) and Musashi
Time frame: approximately 63 days
Potential Blood Biomarkers
Lab testing will be completed to evaluate potential biomarkers in the blood samples. Test may include CTCs/circCSC enumeration, Single CTC/circCSC transcription profiling, immune profiling \[CD4+CD8+ T cells, MDSC (IDO-1+HLR-DR-/lowCD33+CD11b+CD14+), Immunosuppressive plasmocytes (CD19+CD138+IgA+IL-10+PD-L1+), Th17 (CD3+gdTCR+IL-17A+), Treg (CD4+Foxp3+), Hypo-responsive NK cells (CD3-CD56+KIR-NKG2A-), cfDNA, GPC1+ exosomes.
Time frame: approximately 63 days
Changes in Circulating Tumor Stem Cells
Lab testing will be completed to evaluate changes in numbers of circulating tumor stem cells and macrophage lineage changes
Time frame: approximately 63 days
| Milestone | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Ascorbic Acid 75 g/m^2 |
|---|---|---|---|---|
| Started | 6 | 4 | 7 | 0 |
| Completed | 6 | 4 | 7 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the total dose received of ascorbic acid (g/m\^2) by participants was measured.
| Dose (g/m^2) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.5 g/m^2 | Ascorbic Acid 56.25 g/m^2 |
|---|---|---|---|
| Total Dose Received [Identifying Recommended Maximum Tolerated Dose (MTD)] | 235.3 ± 66.3 | 410.4 ± 62.0 | 589.1 ± 135.7 |
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the duration of ascorbic acid dose in days is reported.
| Days | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.5 g/m^2 | Ascorbic Acid 56.25 g/m^2 |
|---|---|---|---|
| Duration of Dose in Days [Identifying Recommended Maximum Tolerated Dose (MTD)] | 235.5 ± 51.9 | 165.9 ± 51.4 | 149.0 ± 54.2 |
Incidence of adverse events reported according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
| count of adverse event term | Ascorbic Acid |
|---|---|
| 25 g/m2 | 4.0 ± 3.4 |
| 37.5 g/m2 | 3.0 ± 1.4 |
| 56.25 g/m2 | 3.1 ± 2.3 |
The percentage of patients who had elevated levels of tumor marker CA 19-9 (or CA-125/CEA if not expressors of CA 19-9) and had their levels normalize. Elevated levels were defined as any value \>35 U/mL for CA 19-9, \>35 U/mL for CA-125, and \>3 ng/mL for CEA. Normalization was defined as any patient who had elevated tumor marker values at baseline and decreased to CA 19-9 value of 0.0-35 U/mL, CA-125 value of 0.0-35 U/mL, or CEA value of 0.0-3 ng/mL during treatment.
| Participants | Ascorbic Acid 25g/m^2 | Ascorbic Acid 37.5 gm^2 | Ascorbic Acid 56.25 g/m^2 |
|---|---|---|---|
| CA 19-9 Normalized | 1 | 0 | 3 |
| CEA Normalized | 1 | 0 | 0 |
| CA-125 Normalized | 3 | 1 | 0 |
Telephone follow-up conducted every 12 weeks from the last dose of treatment to determine survival status.
| months | Ascorbic Acid 25 g/m2 | Ascorbic Acid 37.50 gm/m2 | Ascorbic Acid 56.25 gm/m2 |
|---|---|---|---|
| Overall Survival | 14.2 (5.0 to —) | 7.7 (2.5 to —) | 15.9 (2.4 to —) |
Telephone follow-up conducted every 12 weeks from the last dose of treatment to determine status of disease progression.
| months | Ascorbic Acid 25 g/m2 | Ascorbic Acid 37.50 gm/m2 | Ascorbic Acid 56.25 gm/m2 |
|---|---|---|---|
| Progression-free Survival | 8.9 (3.6 to —) | 6.4 (2.1 to —) | 5.7 (1.5 to 10.1) |
Changes in patient's self-reported quality of life as determined by administering the MD Anderson Symptom Inventory (MDASI-GI). This questionnaire asks patients to rank the severity of symptoms using a 0-10 scale (0 = not present to 10 = as bad as you can imagine) and averages the responses of 18 questions to produce an MDASI-GI score on a 0-10 scale. MDASI-GI scores measured at the start of Cycle 1 and at the end of treatment (EOT) are reported here.
| MDASI-GI Score | Ascorbic Acid 25 g/m2 | Ascorbic Acid 37.50 gm/m2 | Ascorbic Acid 56.25 gm/m2 |
|---|---|---|---|
| Start of Cycle 1 | 1.8 ± 1.5 | 3.7 ± 2.8 | 1.9 ± 2.0 |
| End of Treatment (EOT) | 0.8 ± 0.4 | 1.4 ± 0.8 | 1.5 ± 2.0 |
Changes in patient's self-reported pain levels determined by administering the Brief Pain Inventory (BPI) - Pain Intensity (PI) assessment. This questionnaire asks about pain intensity using a 0-10 scale (0 = not present to 10 = as bad as you can imagine) and averages the responses of 4 questions to output a BPI-PI score on a 0-10 scale. BPI-PI scores measured at the start of Cycle 1 and at the end of treatment (EOT) are reported here.
| BPI-PI Score | Ascorbic Acid 25 g/m2 | Ascorbic Acid 37.50 gm/m2 | Ascorbic Acid 56.25 gm/m2 |
|---|---|---|---|
| Start of Cycle 1 | 1.90 ± 1.8 | 3.5 ± 1.2 | 2.4 ± 1.9 |
| End of Treatment (EOT) | 0.7 ± 0.9 | 3.0 ± 1.1 | 0.9 ± 1.9 |
Imaging completed to evaluate tumor texture on radiologic scans as a non-invasive imaging biomarker for response, biologic, pathologic and outcome measures.
Results for this outcome have not been posted.
Lab testing will be completed to evaluate the correlation between peak plasma concentration of ascorbic acid and response to treatment
Results for this outcome have not been posted.
Tumor biopsy testing will be completed to evaluate potential biomarkers in the tumor including tumor immune cell infiltration, stromal activation, stem cell enumeration, metabolic profiles, whole exome and whole genome CN, ChIP-seq/ATAQ seq, IHC and PCR assays on immune cell populations, CAFs, stem cell content (CD133, Aldh) and Musashi
Results for this outcome have not been posted.
Lab testing will be completed to evaluate potential biomarkers in the blood samples. Test may include CTCs/circCSC enumeration, Single CTC/circCSC transcription profiling, immune profiling \[CD4+CD8+ T cells, MDSC (IDO-1+HLR-DR-/lowCD33+CD11b+CD14+), Immunosuppressive plasmocytes (CD19+CD138+IgA+IL-10+PD-L1+), Th17 (CD3+gdTCR+IL-17A+), Treg (CD4+Foxp3+), Hypo-responsive NK cells (CD3-CD56+KIR-NKG2A-), cfDNA, GPC1+ exosomes.
Results for this outcome have not been posted.
Lab testing will be completed to evaluate changes in numbers of circulating tumor stem cells and macrophage lineage changes
Results for this outcome have not been posted.
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the duration of ascorbic acid dose in weeks is reported.
| Weeks | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.5 g/m^2 | Ascorbic Acid 56.25 g/m^2 |
|---|---|---|---|
| Duration of Dose in Weeks [Identifying Recommended Maximum Tolerated Dose (MTD)] | 33.6 ± 7.4 | 23.7 ± 7.3 | 21.3 ± 7.7 |
Preliminary efficacy as measured by disease control rate (DCR), defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) at 18 weeks according to RECIST v1.1. CR = disappearance of all target lesions; PR = at least 30% decrease in sum of the longest diameters for target lesions, SD = insufficient change to qualify for PR or progressive disease \[defined as at least 20% increase in sum of the longest diameters for target lesions\].
| Percentage of participants | Ascorbic Acid 25 g/m2 | Ascorbic Acid 37.50 gm/m2 | Ascorbic Acid 56.25 gm/m2 |
|---|---|---|---|
| Disease Control Rate (CR+PR+SD at 18 Weeks) | 83.3 (35.9 to 99.6) | 75.0 (19.4 to 99.4) | 57.1 (9.9 to 81.6) |
Best overall response according to RECIST v1.1. Complete response (CR) = disappearance of all target lesions; Partial response (PD) = at least 30% decrease in sum of the longest diameters for target lesions; Stable disease (SD) = insufficient change to qualify for PR or PD; Progressive disease (PD) = at least 20% increase in sum of the longest diameters for target lesions.
| Participants | Ascorbic Acid 25 g/m2 | Ascorbic Acid 37.50 gm/m2 | Ascorbic Acid 56.25 gm/m2 |
|---|---|---|---|
| Complete Response (CR) | 0 | 0 | 0 |
| Partial Response (PR) | 5 | 3 | 3 |
| Stable Disease (SD) | 1 | 0 | 2 |
| Progressive Disease (PD) | 0 | 1 | 2 |
Collected over Adverse events were collected from enrollment through 30 days after the end of treatment, up to 40 weeks. All-cause mortality was assessed from enrollment through follow-up, up to 3 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ascorbic Acid 25 g/m^2 | 6/6 (100%) | 0/6 (0%) | 6/6 (100%) |
| Ascorbic Acid 37.5 g/m^2 | 4/4 (100%) | 0/4 (0%) | 4/4 (100%) |
| Ascorbic Acid 56.25 g/m^2 | 6/7 (85.7%) | 2/7 (28.6%) | 7/7 (100%) |
| Event | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.5 g/m^2 | Ascorbic Acid 56.25 g/m^2 |
|---|---|---|---|
| Platelet count decreasedInvestigations | 0/6 | 0/4 | 1/7 |
| Neutrophil count decreasedInvestigations | 0/6 | 0/4 | 1/7 |
| ColitisHepatobiliary disorders | 0/6 | 0/4 | 1/7 |
| EnterocolitisGastrointestinal disorders | 0/6 | 0/4 | 1/7 |
| Event | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.5 g/m^2 | Ascorbic Acid 56.25 g/m^2 |
|---|---|---|---|
| HypomagnesemiaMetabolism and nutrition disorders | 4/6 | 4/4 | 4/7 |
| thrombocytopeniaVascular disorders | 5/6 | 4/4 | 6/7 |
| neutropeniaImmune system disorders | 5/6 | 0/4 | 2/7 |
| hypokalemiaBlood and lymphatic system disorders | 4/6 | 2/4 | 2/7 |
| AnemiaBlood and lymphatic system disorders | 2/6 | 1/4 | 3/7 |
| Age, Continuous(years) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Total |
|---|---|---|---|---|
| Age | 67.3 (47.7 to 72.2) | 59.9 (47.3 to 63.3) | 63.9 (48.2 to 75.9) | 63.9 (47.3 to 75.9) |
| Sex: Female, Male(Participants) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Total |
|---|---|---|---|---|
| Gender — Female | 4 | 2 | 6 | 12 |
| Gender — Male | 2 | 2 | 1 | 5 |
| Race (NIH/OMB)(Participants) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Total |
|---|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Race — Asian | 0 | 0 | 0 | 0 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Race — Black or African American | 0 | 0 | 0 | 0 |
| Race — White | 6 | 4 | 7 | 17 |
| Race — More than one race | 0 | 0 | 0 | 0 |
| Race — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Total |
|---|---|---|---|---|
| Ethnicity — Hispanic or Latino | 2 | 0 | 1 | 3 |
| Ethnicity — Not Hispanic or Latino | 4 | 4 | 6 | 14 |
| Ethnicity — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Total |
|---|---|---|---|---|
| United States | 6 | 4 | 7 | 17 |
| ECOG Score(Participants) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Total |
|---|---|---|---|---|
| ECOG Score 0 | 4 | 1 | 3 | 8 |
| ECOG Score 1 | 2 | 3 | 4 | 9 |
| Baseline CA 19-9(Participants) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Total |
|---|---|---|---|---|
| Normal | 1 | 1 | 1 | 3 |
| Elevated | 5 | 3 | 6 | 14 |
| Primary Site of Tumor(Participants) | Ascorbic Acid 25 g/m^2 | Ascorbic Acid 37.50 g/m^2 | Ascorbic Acid 56.25 g/m^2 | Total |
|---|---|---|---|---|
| Body of Pancreas | 1 | 1 | 1 | 3 |
| Head of Pancreas | 4 | 2 | 3 | 9 |
| Neck of Pancreas | 0 | 0 | 1 | 1 |
| Tail of Pancreas | 1 | 1 | 3 | 5 |
12 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — If the study site is a 'covered site' under the definitions of the Health Insurance Portability and Accounting Act (HIPAA), the Investigator will ensure that the patient consents to the use of data by HonorHealth and its designees for the purposes of regulatory submissions, study publications, and drug approval. SU2C will be notified of any outputs of the research such as guidelines, publications, presentation, changes in service delivery etc. prior to external submission or presentation. In any oral or written report or poster presentation of Results or otherwise relating to the Research, the support of CRUK, SU2C and the Lustgarten foundation will be acknowledged, displaying the relevant logs where possible. Any publications resulting from research funded in whole or in part by the Grant must be cited as required per signed confidentiality agreements.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: to be determined
Access criteria: The Investigator and any other study personnel involved in this study shall not disclose, or use for any purposes (other than for the performance of this study), any data, records, or other information (hereinafter collectively "information") disclosed to the Investigator or other study personnel. Such information shall remain the confidential and proprietary property of HonorHealth, and shall be disclosed only to the Investigator or other designated study personnel. The obligation of non-disclosure shall not apply to the following: relevant disclosure to potential study participants for the purpose of obtaining informed consent; information after such time that it is or becomes publicly available through no fault of the Investigator or other study personnel; and, information after such time that it is disclosed to the Investigator by a third party entitled to disclose such information.
Ran from Dec 2017 to primary completion in Sep 2021, 44 months.
Results were first posted in Jul 2026, 4 years 10 months after primary completion.
Of 94 non-industry phase 1/2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 95. This study's 44 months is below that.
Counting every sponsor, half of 209 studies reached it within 51 months; a quarter within 36 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ascorbic Acid
HonorHealth Research Institute