Pancreatic CancerPhase 2NCT06153368
Cadonilimab Plus mFOLFIRINOX as Conversion Therapy in LAPC
A Phase 2 study testing Cadonilimab+mFOLFIRINOX in people with Pancreatic Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a prospective, single arm, single center, phase II study of cadonilimab plus mFOLFIRINOX as conversion therapy in patients with locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cadonilimab+mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2023to 27 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
- Patients must have locally advanced pancreatic cancer (LAPC).
- Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
- Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with
- extension to the celiac axis or superior mesenteric artery,
- occlusion of the superior mesenteric-portal venous confluence
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- aortic, inferior vena cava (IVC) invasion or encasement
- invasion of superior mesenteric vein below transverse mesocolon or unresectable after surgical exploration.
- Those who had superior mesenteric vein impingement, superior mesenteric artery abutment were defined as borderline resectable.
- Those who had superior mesenteric vein occlusion, superior mesenteric artery encasement were defined as unresectable.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
- Age ≥18years and ≤75 years.
- Eastern Cooperative Oncology Group performance score of 0 or 1; see Appendix A.
- Patients must have normal organ and marrow function
- Patients who present with jaundice will be allowed to enroll after control with temporary or permanent internal/external drainage.
- The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with distant metastases are not eligible.
- Patients with endocrine or acinar pancreatic carcinoma.
- Patients may be receiving any steroid, immunologic or other investigational agents within 4 weeks prior to enrollment.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
- Patients who have above grade II peripheral neuropathy.
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- Patients who had non-curable second primary malignancy within five years, except for non-melanoma skin cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
- Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded from the study because of increased risk of lethal infections and possible pharmacokinetic interactions with study agent administered during the study.
Trial locations and contacts
1 site in 1 country.
Min Tu, MD contact
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Jiang K rong, +86-153-1299-5688, jiangkuirong@njmu.edu.cn
About this study
Official title: Cadonilimab Plus mFOLFIRINOX as Conversion Therapy in Patients With Locally Advanced Pancreatic Cancer：A Prospective, Single-arm, Phase II Trial
This is a prospective, single arm, single center, phase II study of cadonilimab plus mFOLFIRINOX as conversion therapy in patients with locally advanced pancreatic cancer.
Read the detailed description
Eligible patients with histologically/cytologically confirmed unresectable locally advanced pancreatic cancer (LAPC) will receive cadonilimab (6mg/kg，IVD，D1，Q2W) plus mFOLFIRINOX (oxaliplatin 85mg/m2 , D2 + leucovorin 400mg/m2 , D2 + irinotecan 150mg/m2 , D2 + 5-fluorouracil 2,400mg/m2 46h continuous infusion ) for 4 cycles (8 weeks).
After completing every 4 treatment cycles, the subjects will undergo imaging examinations of tumor lesions. If the subjects do not experience disease progression, they will continue to receive treatment until surgical resection, disease progression (RECIST 1.1), or intolerable toxic reactions occur, new anticancer drug treatment begins, withdrawal from the study, death, or loss of follow-up. All subjects who have received treatment are required to undergo efficacy evaluation every 8 weeks (± 7 days) after the start of treatment, until disease progression or study termination. After the 12th cycle of treatment, the maintenance treatment plan is to use capecitabine or S-1 combined with cadonilimab for maintenance treatment. During maintenance treatment, imaging efficacy evaluation is conducted every 12 weeks (± 7 days), and surgical resectability is still evaluated until surgical resection, disease progression (RECIST 1.1) or intolerable toxic reactions occur, new anticancer drug treatment begins, withdrawal from the study, death, or loss of follow-up.
- Conditions
- Pancreatic Cancer
- Being tested
- Cadonilimab+mFOLFIRINOX
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab+mFOLFIRINOXDrug
Also called Cadonilimab+Oxaliplatin+ Irinotecan+ Leucovorin+ 5-fluorouracil
Cadonilimab 6 mg/kg，IVD，D1，Q2W
+mFOLFIRINOX（Oxaliplatin 85 mg/m2 IV over 4 hours ; Irinotecan 150 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion.） on days 2 of a 14-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab | Experimental | Drug：Cadonilimab 6 mg/kg，IVD，D1，Q2W Drug：mFOLFIRINOX mFOLFIRINOX（Oxaliplatin 85 mg/m2 IV over 4 hours ; Irinotecan 150 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion.） on days 2 of a 14-day cycle. Receives: Drug: Cadonilimab+mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.
Measured: Up to 1 year
Secondary outcomes (3)
Progression free survival (PFS)
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Measured: Up to two years
Overall survival (OS)
The duration from the date of recruitment to the date of death from any cause.
Measured: Up to two years
Adverse events (safety)
Adverse events (safety ) will be evaluated according to the NCI CTCAE Version 5.0.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start19 Dec 2023 (estimated)
- Primary completion27 Nov 2024 (estimated)
- Study completion27 Nov 2025 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuirong Jiang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Rong K Jiang, MD, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153368
- Sponsor's protocol ID
- 2023-SR-566
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cadonilimab Plus mFOLFIRINOX as Conversion Therapy in Patients With Locally Advanced Pancreatic Cancer：A Prospective, Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT06153368
- Acronym / sponsor ID
- 2023-SR-566
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 19 Dec 2023 (estimated)
- Primary completion
- 27 Nov 2024 (estimated)
- Study completion
- 27 Nov 2025 (estimated)
- First posted
- 1 Dec 2023 (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.
This is a prospective, single arm, single center, phase II study of cadonilimab plus mFOLFIRINOX as conversion therapy in patients with locally advanced pancreatic cancer.
Detailed description
Eligible patients with histologically/cytologically confirmed unresectable locally advanced pancreatic cancer (LAPC) will receive cadonilimab (6mg/kg，IVD，D1，Q2W) plus mFOLFIRINOX (oxaliplatin 85mg/m2 , D2 + leucovorin 400mg/m2 , D2 + irinotecan 150mg/m2 , D2 + 5-fluorouracil 2,400mg/m2 46h continuous infusion ) for 4 cycles (8 weeks).
After completing every 4 treatment cycles, the subjects will undergo imaging examinations of tumor lesions. If the subjects do not experience disease progression, they will continue to receive treatment until surgical resection, disease progression (RECIST 1.1), or intolerable toxic reactions occur, new anticancer drug treatment begins, withdrawal from the study, death, or loss of follow-up. All subjects who have received treatment are required to undergo efficacy evaluation every 8 weeks (± 7 days) after the start of treatment, until disease progression or study termination. After the 12th cycle of treatment, the maintenance treatment plan is to use capecitabine or S-1 combined with cadonilimab for maintenance treatment. During maintenance treatment, imaging efficacy evaluation is conducted every 12 weeks (± 7 days), and surgical resectability is still evaluated until surgical resection, disease progression (RECIST 1.1) or intolerable toxic reactions occur, new anticancer drug treatment begins, withdrawal from the study, death, or loss of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab | Experimental | Drug: Cadonilimab+mFOLFIRINOXDrug：Cadonilimab 6 mg/kg，IVD，D1，Q2W Drug：mFOLFIRINOX mFOLFIRINOX（Oxaliplatin 85 mg/m2 IV over 4 hours ; Irinotecan 150 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion.） on days 2 of a 14-day cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
- Patients must have locally advanced pancreatic cancer (LAPC).
- Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
- Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with
- Those who had superior mesenteric vein impingement, superior mesenteric artery abutment were defined as borderline resectable.
Key exclusion criteria (10 listed)
- Patients with distant metastases are not eligible.
- Patients with endocrine or acinar pancreatic carcinoma.
- Patients may be receiving any steroid, immunologic or other investigational agents within 4 weeks prior to enrollment.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
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 |
|---|---|---|
| Cadonilimab+mFOLFIRINOXAlso: Cadonilimab+Oxaliplatin+ Irinotecan+ Leucovorin+ 5-fluorouracilCadonilimab 6 mg/kg，IVD，D1，Q2W +mFOLFIRINOX（Oxaliplatin 85 mg/m2 IV over 4 hours ; Irinotecan 150 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion.） on days 2 of a 14-day cycle. | Drug | Cadonilimab |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 1 year
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.
3 secondary outcomes
Progression free survival (PFS)
Time frame: Up to two years
Overall survival (OS)
Time frame: Up to two years
Adverse events (safety)
Time frame: Up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available to other researchers.
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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.
Min Tu, MD contact
Rong K Jiang, MD study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadonilimab+mFOLFIRINOX in people with Pancreatic Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 17 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong K Jiang, MD (+8615312995688, jiangkuirong@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 1 year). 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 7 Dec 2023.