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Trial Title:
Irinotecan Liposome，Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer
NCT ID:
NCT06513455
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Irinotecan
Conditions: Keywords:
Irinotecan Liposome
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan liposome（40mg/m2）
Description:
irinotecan Liposome was administered 40mg/m2, D1，iv. q2w
Arm group label:
Cohort A
Other name:
Irinotecan Liposome
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
Albumin Paclitaxel
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
Gemcitabine injection
Intervention type:
Drug
Intervention name:
Irinotecan Liposome（60mg/m2）
Description:
irinotecan Liposome was administered 60mg/m2, D1，iv. q2w
Arm group label:
Cohort B
Other name:
Irinotecan Liposome
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18 to 75 years old, male or female;
2. Patients with pancreatic cancer diagnosed by histology or cytology;
3. Not received anti-tumor system treatment (if received neoadjuvant or adjuvant
therapy, need to ensure that the last time is more than 6 months)；
4. With measurable tumor lesions (spiral CT scan ≥10mm, meet RECIST 1.1 standard);
5. ECOG PS: 0-1 points;
6. Expected survival time> 3 months;
7. The functions of important organs meet the following requirements:
1. Absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥9g/dL;
2. Bilirubin ≤ 1.5 times ULN (patients drained by retrograde technique may be
included); ALT and AST ≤ 3 times ULN;
3. Creatinine ≤ 1.5 times, or MDRD creatinine clearance rate> 50 mL/min;
8. 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;
9. Signature of patient information and informed consent.
Exclusion Criteria:
1. Previous allergy to irinotecan liposome, other liposome products, fluorouracil and
other therapeutic drugs;
2. previous or concurrent history of other malignant tumors, except cured basal cell
carcinoma of the skin and carcinoma in situ of the cervix;
3. Participated in other drug clinical trials within 4 weeks before randomization;
4. Severe gastrointestinal dysfunction;
5. 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;
6. Peripheral neuropathy (CTCAE≥ grade 3);
7. 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；
8. Interstitial lung disease, except interstitial changes only on imaging;
9. Screening patients with known or history of central nervous system metastases;
10. Concomitant medication containing a strong inhibitor/strong inducer of CYP3A4,
CYP2C8, or a strong inhibitor of UGT1A1 within 2 weeks before randomization;
11. 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);
12. 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；
13. Pregnant women or those who expect to become pregnant during the study treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Harbin Medical University
Agency class:
Other
Source:
Harbin Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06513455
