Nanoliposomal IrinotecanPhase 2NCT06405490
NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC
A Phase 2 study testing Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab in people with Nanoliposomal Irinotecan and Cadonilimab, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nanoliposomal Irinotecan, Cadonilimab, Oxaliplatin
- What is being tested?
- Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab
- 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
- 17 Apr 2024to 30 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, male or female;
- Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
- Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
- Has a life expectancy of at least 3 months;
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- Has adequate organ function;
- If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
- If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.
Who cannot join
- Untreated active CNS metastasis or leptomeningeal metastasis.
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
- Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
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- Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
- History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
- Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；
- Is pregnant or breastfeeding;
- Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
Official title: Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study
This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.
- Conditions
- Nanoliposomal Irinotecan, Cadonilimab, Oxaliplatin, Capecitabine, First-Line, Advanced Cancer
- Being tested
- Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab
- Keywords
- Pancreatic Adenocarcinoma, Nanoliposomal Irinotecan, Cadonilimab, First-Line Treatment, Advanced Pancreatic Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+CadonilimabDrug
Use the above medications on a regular basis
| Study group | Role | What they receive |
|---|---|---|
| NALIRI-XELOX+AK104 | Experimental | Every 2 weeks as a cycle:
1. Nanoliposomal Irinotecan: 47.1mg/m2, iv, d1;
2. Cadonilimab: 6mg/kg, iv, d3;
3. Oxaliplatin: 70mg/m2, iv, d1;
4. Capecitabine: 1000mg/m2, bid, po, d1-d7; Re-evaluate patients every three cycles. If the patient has been treated for more than 9 cycles, they will enter maintenance therapy, and the regimen is capecitabine +Cadonilimab. Receives: Drug: Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR of regimen of NALIRI-XELOX+AK104
Measured: 2 years
Secondary outcomes (6)
Duration of Response (DoR)
Measured: 2 years
Disease Control Rate (DCR)
Measured: 2 years
Median Progression-Free Survival (mPFS)
Measured: 1 years
12-month PFS rate
Measured: 12 months
Median Overall Survival (mOS)
Measured: 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Adverse Events (AEs) Incidence, Serious Adverse Events (SAE) Incidence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start17 Apr 2024
- Primary completion30 Aug 2026 (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 Nanoliposomal IrinotecanStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405490
- Sponsor's protocol ID
- NCC4398
- Status last verified
- Dec 2024
- First submitted
- 5 May 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT06405490
- Acronym / sponsor ID
- NCC4398
- Conditions
- Nanoliposomal Irinotecan, Cadonilimab, Oxaliplatin, Capecitabine, First-Line, Advanced Cancer
- Keywords
- Pancreatic Adenocarcinoma, Nanoliposomal Irinotecan, Cadonilimab, First-Line Treatment, Advanced Pancreatic Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 May 2024 (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 study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NALIRI-XELOX+AK104 | Experimental | Drug: Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+CadonilimabEvery 2 weeks as a cycle: 1. Nanoliposomal Irinotecan: 47.1mg/m2, iv, d1; 2. Cadonilimab: 6mg/kg, iv, d3; 3. Oxaliplatin: 70mg/m2, iv, d1; 4. Capecitabine: 1000mg/m2, bid, po, d1-d7; Re-evaluate patients every three cycles. If the patient has been treated for more than 9 cycles, they will enter maintenance therapy, and the regimen is capecitabine +Cadonilimab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18, male or female;
- Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
- Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
Key exclusion criteria (12 listed)
- Untreated active CNS metastasis or leptomeningeal metastasis.
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
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 |
|---|---|---|
| Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+CadonilimabUse the above medications on a regular basis | Drug | NALIRI-XELOX+AK104 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
ORR of regimen of NALIRI-XELOX+AK104
6 secondary outcomes
Duration of Response (DoR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Median Progression-Free Survival (mPFS)
Time frame: 1 years
12-month PFS rate
Time frame: 12 months
Median Overall Survival (mOS)
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Adverse Events (AEs) Incidence, Serious Adverse Events (SAE) Incidence
Time frame: 2 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 24 Dec 2024.
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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.
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 Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab in people with Nanoliposomal Irinotecan and Cadonilimab, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 9 inclusion and 12 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 24 Dec 2024. 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 lin yang (13611267380, linyangcicams@126.com), 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: 2 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 24 Dec 2024.