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AzTrials

Pancreatic CancerPhase 2PTCA199-10NCT06249321

mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy

A Phase 2 study testing mFOLFIRINOX plus IMRT in people with Pancreatic Cancer and Radiotherapy, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer refractory to chemotherapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreatic Cancer, Radiotherapy
What is being tested?
mFOLFIRINOX plus IMRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Apr 2024to 1 Mar 2028
Phase
Phase 2
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and the willingness to sign a written informed consent document.
  • Age ≥ 18 years and ≤ 80 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
  • Patients who are refractory to at least one line of chemotherapy and who have not received radiotherapy.
  • Locally advanced or distant metastatic pancreatic cancer.
Show all 11Show fewer
  • Baseline serum CA19-9 ≤ 37 U/mL, CEA≤ 5.2 ng/mL, and CA125 ≤ 35 U/mL.
  • Presence of at least of one measurable lesion in agreement to RECIST criteria.
  • The expected survival ≥ 3 months.
  • Adequate organ performance based on laboratory blood tests.
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Who cannot join

  • Pregnant or nursing women.
  • Primary pancreatic cancer.
  • Baseline serum CA19-9 > 37 U/mL, CEA > 5.2 ng/mL, or CA125 > 35 U/mL.
  • The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
  • Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
  • Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
Show all 10Show fewer
  • Renal insufficiency or dialysis
  • Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
  • Patients who are allergic to oxaplatin or other chemotherapy drugs.
  • Patients who are unwilling or unable to comply with study procedures.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Yang, MD contact

86 64175590 ext. 1307

yangying@fudanpci.org

China1 site, 1 recruiting

  • Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Ying Yang, MD, 86 21 64175590 ext. 1307, yangying@fudanpci.org

    Guopei Luo, MD

    Recruiting

Other trials in China

About this study

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer refractory to chemotherapy.

Read the detailed description

Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity.

Carbohydrate antigen 19-9 (CA19-9) is the most widely used biomarker in pancreatic cancer. Circulating CA19-9 levels are positively correlated with tumor burden and stage in pancreatic cancer with a diagnostic sensitivity of approximately 80%, suggesting that approximately 20% of patients have normal CA19-9 levels. It is well recognized that Lewis (-) individuals, constituting approximately 10% of the population, have low or no secretion of CA19-9 due to the lack of critical enzyme involved in CA19-9 biosynthesis. Thus, approximately 10% of patients with pancreatic cancer have normal CA19-9 levels regardless of tumor stage. Our previously retrospective study has shown that CA19-9-normal advanced pancreatic cancer may be more sensitive to chemotherapy combined with radiotherapy.

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to patients with CA19-9-normal advanced pancreatic cancer who are refractory to chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every four weeks.

Being tested
mFOLFIRINOX plus IMRT
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mFOLFIRINOX plus IMRTDrug

    Chemotherapy will be administered according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline and a modified FOLFIRINOX regimen will be the first choice. Patients with advanced pancreatic adenocarcinoma will receive the modified FOLFIRINOX regimen (oxaliplatin [70 mg per square meter of body surface area], irinotecan [130 mg per square meter], leucovorin [200 mg per square meter], and fluorouracil [2000 mg per square meter] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy. The following treatment after radiotherapy will be applied according to the newest edition of NCCN guideline.

Study groups in NCT06249321
Study groupRoleWhat they receive
mFOLFIRINOX plus radiotherapyExperimentalPatients with advanced pancreatic adenocarcinoma will receive the modified FOLFIRINOX regimen (oxaliplatin [70 mg per square meter of body surface area], irinotecan [130 mg per square meter], leucovorin [200 mg per square meter], and fluorouracil [2000 mg per square meter] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy.
Receives: Drug: mFOLFIRINOX plus IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival, PFS

    PFS of subjects from recruiting to the time of disease progression

    Measured: At the end of Cycle 1 (each cycle is 28 days)

Secondary outcomes (3)

  1. Overall survival，OS

    OS of subjects from recruiting to the time of death from any cause

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. objective response rate (ORR)

    CR + PR

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. disease control rate (DCR)

    CR + PR + SD

    Measured: At the end of Cycle 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249321
Sponsor's protocol ID
PTCA199-10
Acronym
PTCA199-10
Status last verified
Mar 2025
First submitted
31 Jan 2024
Last updated
7 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Luo G, Liu C, Guo M, Long J, Liu Z, Xiao Z, Jin K, Cheng H, Lu Y, Ni Q, Yu X. CA19-9-Low&Lewis (+) pancreatic cancer: A unique subtype. Cancer Lett. 2017 Jan 28;385:46-50. doi: 10.1016/j.canlet.2016.10.046. Epub 2016 Nov 10.

    PubMed 27840089

  • Luo G, Liu C, Guo M, Cheng H, Lu Y, Jin K, Liu L, Long J, Xu J, Lu R, Ni Q, Yu X. Potential Biomarkers in Lewis Negative Patients With Pancreatic Cancer. Ann Surg. 2017 Apr;265(4):800-805. doi: 10.1097/SLA.0000000000001741.

    PubMed 28267695

  • Luo G, Jin K, Guo M, Cheng H, Liu Z, Xiao Z, Lu Y, Long J, Liu L, Xu J, Liu C, Gao Y, Ni Q, Yu X. Patients with normal-range CA19-9 levels represent a distinct subgroup of pancreatic cancer patients. Oncol Lett. 2017 Feb;13(2):881-886. doi: 10.3892/ol.2016.5501. Epub 2016 Dec 14.

    PubMed 28356973

  • Zhu X, Xiao Z, Liu H, Zhang P, Deng S, Ding L, Feng J, Luo J, Ni Q, Luo G, Yu X. Pancreatic Cancer: An Exocrine Tumor With Endocrine Characteristics. Ann Surg. 2024 Dec 1;280(6):e17-e25. doi: 10.1097/SLA.0000000000006168. Epub 2023 Dec 5.

    PubMed 38050737

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mFOLFIRINOX plus IMRT in people with Pancreatic Cancer and Radiotherapy, run by Fudan University at 1 site in China.

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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 7 Aug 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Ying Yang, MD (86 64175590 ext. 1307, yangying@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival, PFS (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06249321, which also lists 4 linked publications.

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 7 Aug 2025.

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