Pancreatic CancerPhase 1/2NCT06513455
Irinotecan Liposome，Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer
A Phase 1/2 study testing Irinotecan liposome（40mg/m2）, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by Harbin Medical University.
Trial summary
This is a Phase I/II , Open-label , Investigator-initiated Trail of liposomal irinotecan,nab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect… 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?
- Irinotecan liposome（40mg/m2）, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Dec 2027
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 75 years old, male or female;
- Patients with pancreatic cancer diagnosed by histology or cytology;
- Not received anti-tumor system treatment (if received neoadjuvant or adjuvant therapy, need to ensure that the last time is more than 6 months)；
- With measurable tumor lesions (spiral CT scan ≥10mm, meet RECIST 1.1 standard);
- ECOG PS: 0-1 points;
- Expected survival time> 3 months;
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- The functions of important organs meet the following requirements:
- Absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥9g/dL;
- Bilirubin ≤ 1.5 times ULN (patients drained by retrograde technique may be included); ALT and AST ≤ 3 times ULN;
- Creatinine ≤ 1.5 times, or MDRD creatinine clearance rate> 50 mL/min;
- Women of childbearing age must undergo a negative pregnancy test (βHCG) before starting treatment. Women and men of childbearing age (sexual relationships with women of childbearing age) must agree to use them effectively during treatment and 6 months after the last dose of treatment Contraceptive measures;
- Signature of patient information and informed consent.
Who cannot join
- Previous allergy to irinotecan liposome, other liposome products, fluorouracil and other therapeutic drugs;
- previous or concurrent history of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Participated in other drug clinical trials within 4 weeks before randomization;
- Severe gastrointestinal dysfunction;
- The presence of third space effusion (e.g., massive pleural effusion) in addition to ascites that could not reach a stable state within 2 weeks before randomization;
- Peripheral neuropathy (CTCAE≥ grade 3);
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- Patients with a history of bleeding, with any bleeding event of CTCAE 5.0 grade 3 or higher within 4 weeks before screening; Gastrointestinal bleeding of CTCAE grade 3 or higher was reported within 6 months before randomization or within 1 month before randomization；
- Interstitial lung disease, except interstitial changes only on imaging;
- Screening patients with known or history of central nervous system metastases;
- Concomitant medication containing a strong inhibitor/strong inducer of CYP3A4, CYP2C8, or a strong inhibitor of UGT1A1 within 2 weeks before randomization;
- Severe infection (CTCAE > grade 2) within 4 weeks before treatment; Signs and symptoms of infection requiring treatment with intravenous antibiotics within 2 weeks before the initiation of treatment (except for prophylactic antibiotics);
- Judging by the researchers, the participants have other factors that could lead to the forced midway termination of research, may affect the participants were given safety or test data collection, etc；
- Pregnant women or those who expect to become pregnant during the study treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Irinotecan Liposome Combined With Albumin Paclitaxel and Gemcitabine as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
This is a Phase I/II , Open-label , Investigator-initiated Trail of liposomal irinotecan,nab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.
The first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxel，gemcitabine and liposomal irinotecan at different dose Levels(40 mg/m2, iv. q2w or 60 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .
This study aims to evaluate the safety and efficacy of liposomal irinotecan，nab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer.
Read the detailed description
The study consists of a dose escalation and expansion phase to determine the recommended Phase 2 dose (RP2D) for liposomal irinotecan combination with AG, and a dose confirmation phase which will further characterize the treatment of liposomal irinotecan in combination at the RP2D.
- Conditions
- Pancreatic Cancer
- Being tested
- Irinotecan liposome（40mg/m2）, Nab-paclitaxel, Gemcitabine, Irinotecan Liposome（60mg/m2）
- Keywords
- Irinotecan Liposome
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome（40mg/m2）Drug
Also called Irinotecan Liposome
irinotecan Liposome was administered 40mg/m2, D1，iv. q2w
Nab-paclitaxelDrug
Also called Albumin Paclitaxel
Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w
GemcitabineDrug
Also called Gemcitabine injection
gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w
Irinotecan Liposome（60mg/m2）Drug
Also called Irinotecan Liposome
irinotecan Liposome was administered 60mg/m2, D1，iv. q2w
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w，gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w，irinotecan Liposome was administered 40mg/m2, D1，iv. q2w Receives: Drug: Irinotecan liposome（40mg/m2）; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Cohort B | Experimental | Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w，gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w，irinotecan Liposome was administered 60mg/m2, D1，iv. q2w Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Irinotecan Liposome（60mg/m2） |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD /DLT (phase I)
Maximum Tolerated Dose/Dose Limiting Toxicity
Measured: Within four weeks after administration
ORR(phase II)
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Measured: 6 months
Secondary outcomes (4)
Progression free Survival
Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
Measured: 1 year
Overall survival
Defined as the time between signing the informed consent form to death due to various causes.
Measured: 2 years
Disease Control Rate
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
Measured: 6 months
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqiao Zhang, Harbin Medical University
- Investigators
- Yanqiao Zhang, Zhang, Principal investigator, Harbin Medical University Cancer Hosptital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513455
- Sponsor's protocol ID
- MA-PC-II-013
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan Liposome Combined With Albumin Paclitaxel and Gemcitabine as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06513455
- Acronym / sponsor ID
- MA-PC-II-013
- Conditions
- Pancreatic Cancer
- Keywords
- Irinotecan Liposome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 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 is a Phase I/II , Open-label , Investigator-initiated Trail of liposomal irinotecan,nab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.
The first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxel，gemcitabine and liposomal irinotecan at different dose Levels(40 mg/m2, iv. q2w or 60 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .
This study aims to evaluate the safety and efficacy of liposomal irinotecan，nab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer.
Detailed description
The study consists of a dose escalation and expansion phase to determine the recommended Phase 2 dose (RP2D) for liposomal irinotecan combination with AG, and a dose confirmation phase which will further characterize the treatment of liposomal irinotecan in combination at the RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Irinotecan liposome（40mg/m2）, Drug: Nab-paclitaxel, Drug: GemcitabineNab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w，gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w，irinotecan Liposome was administered 40mg/m2, D1，iv. q2w |
| Cohort B | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Irinotecan Liposome（60mg/m2）Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w，gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w，irinotecan Liposome was administered 60mg/m2, D1，iv. q2w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18 to 75 years old, male or female;
- Patients with pancreatic cancer diagnosed by histology or cytology;
- Not received anti-tumor system treatment (if received neoadjuvant or adjuvant therapy, need to ensure that the last time is more than 6 months)；
- With measurable tumor lesions (spiral CT scan ≥10mm, meet RECIST 1.1 standard);
- ECOG PS: 0-1 points;
Key exclusion criteria (13 listed)
- Previous allergy to irinotecan liposome, other liposome products, fluorouracil and other therapeutic drugs;
- previous or concurrent history of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Participated in other drug clinical trials within 4 weeks before randomization;
- Severe gastrointestinal dysfunction;
- The presence of third space effusion (e.g., massive pleural effusion) in addition to ascites that could not reach a stable state within 2 weeks before randomization;
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 |
|---|---|---|
| Irinotecan liposome（40mg/m2）Also: Irinotecan Liposomeirinotecan Liposome was administered 40mg/m2, D1，iv. q2w | Drug | Cohort A |
| Nab-paclitaxelAlso: Albumin PaclitaxelNab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w | Drug | Cohort A, Cohort B |
| GemcitabineAlso: Gemcitabine injectiongemcitabine was administered 1000 mg D1、D8、D15，iv. q4w | Drug | Cohort A, Cohort B |
| Irinotecan Liposome（60mg/m2）Also: Irinotecan Liposomeirinotecan Liposome was administered 60mg/m2, D1，iv. q2w | Drug | Cohort B |
Primary outcome
MTD /DLT (phase I)
Time frame: Within four weeks after administration
Maximum Tolerated Dose/Dose Limiting Toxicity
ORR(phase II)
Time frame: 6 months
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
4 secondary outcomes
Progression free Survival
Time frame: 1 year
Overall survival
Time frame: 2 years
Disease Control Rate
Time frame: 6 months
Incidence of adverse events
Time frame: 6 months
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 22 Jul 2024.
- 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.
Yanqiao Zhang, Zhang principal investigator
Harbin Medical University Cancer Hosptital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Irinotecan liposome（40mg/m2）, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by Harbin Medical University.
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 12 inclusion and 13 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: opening soon, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 Yanqiao Zhang, PhD (+86 138 4512 0210, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD /DLT (phase I) (time frame: Within four weeks after administration). The study lists 2 primary outcomes in all. 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 22 Jul 2024.