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Clinical Trial Record

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Nal-IRI/5-FU/LV Chemotherapy Combined with PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT As Second-line Therapy in Metastatic Pancreatic Cancer Patients

2024-10

2027-12

2027-12

56

Study Overview

Nal-IRI/5-FU/LV Chemotherapy Combined with PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT As Second-line Therapy in Metastatic Pancreatic Cancer Patients

This study is a single-arm, multi-center, multi-cohort, prospective clinical study initiated by the investigator. The indication of this study is: patients with advanced metastatic pancreatic cancer who have progressed after first-line chemotherapy. Eligible patients will be assigned to liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT. The total sample size for this study is expected to be 56 subjects.

For patients with advanced metastatic pancreatic cancer who failed first-line treatment, the screening and enrollment will be completed according to the enrollment and exclusion criteria described in the study protocol, and the informed consent form will be signed after full communication. After enrollment, patients will be treated with cohort A) or cohort B), and followed up regularly. Cohort A: nal-IRI/5-FU/LV + PD-L1 inhibitor + multi-target anti-angiogenic small molecule: Irinotecan liposome: 50mg/m2 IV D1, D15 LV: 400mg/m2 IV D1, D15 5-FU ：2.4g/m2 CIV 46h D1, D15 bemosubaemab: 1200mg IV Q3W Anlotinib: 12mg po D1-D14 Q3W Cohort B: nal-IRI/5-FU/LV + PD-L1 inhibitor+ multi-target anti-angiogenic small molecule+SBRT Group: Irinotecan liposomes: 50mg/m2 IV D1, D15 LV: 400mg/m2 IV D1, D15 5-FU ：2.4g/m2 CIV 46h D1, D15 bemosubaemab: 1200mg IV Q3W Anlotinib: 12mg po D1-D14 Q3W SBRT

  • Advanced Metastatic Pancreatic Cancer
  • DRUG: nal-IRI,5-fu,LV, benmelstobart, anlotinib
  • 24-OBU-JS-PanC-II-015

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-10-17  

N/A  

2024-10-25  

2024-10-25  

N/A  

2024-10-28  

2024-10-28  

N/A  

2024-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: nal-IRI/5-FU/LV + benmelstobart + anlotinib ± SBRT

liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT

DRUG: nal-IRI,5-fu,LV, benmelstobart, anlotinib

  • liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT
Primary Outcome MeasuresMeasure DescriptionTime Frame
Objective effective rate (ORR)The overall response rate, including complete response (CR) + partial response (PR), refers to the proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time.28 days per cycle, with ≤6 cycles of treatment expected per patient
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease control rate (DCR)Refers to the proportion of patients whose tumors have shrunk or stable and remain for a certain period of time, including complete remission (CR), partial remission (PR) and stable (SD) cases.28 days per cycle, with ≤6 cycles of treatment expected per patient
Median overall survival (mOS)Refers to the numerical value in which the survival time of all patients is arranged in the order from smallest to largest in clinical research, and is located in the middle position.28 days per cycle, with ≤6 cycles of treatment expected per patient
Median progression-free survival (mPFS)Refers to the value in which all patients are sorted according to the length of progression-free survival time in clinical studies, and is located in the middle position.28 days per cycle, with ≤6 cycles of treatment expected per patient

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Juan Du

Phone Number: 13951826526

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Age ≥ 18 years and ≤ 75 years, ECOG score of ≤2 points, expected survival time ≥ 3 months. 2. Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer. 3. Imaging suggests distant measurable lesions. 4. Failure of first-line therapy and no use of fluorouracil, irinotecan, or liposomal irinotecan drugs in the first-line therapy.
    Patients need to meet the following hematologic indicators e1. Neutrophil count ≥ 1.5×109/L e2. Hemoglobin ≥ 10 g/dL e3. Platelet count ≥ 100×109/L f. Patients need to meet the following biochemical parameters f1. Total bilirubin ≤ 1.5× upper limit of normal (ULN) f2. AST and ALT <1.5×ULN f3. Creatinine clearance ≥ 60ml/min g. Patients of childbearing age need to take appropriate protective measures (contraception or other methods of birth control) before enrollment and during the trial.
    H. Has signed an informed consent form. i. Able to follow the study protocol and follow-up process.
    Exclusion Criteria:
    1. Have received second-line or more anti-tumor therapy in the past. 2. First-line treatment with fluorouracil, irinotecan or liposomal irinotecan, etc. 3. Patient has a prior history of other tumors, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumors (Ta and TIS) or other malignancies that have received curative therapy (at least more than 5 years prior to enrollment). 4. Patient has an active bacterial or fungal infection (≥ 3rd edition NCI-CTC2 grade).
    Patient has HIV, HCV, HBV infection, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or other disease deemed non-enrollable by the investigator.
    f. Patients with autoimmune diseases or immunodeficiencies who should be treated with immunosuppressive drugs.
    g. Pregnant and lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
    h. Substance abuse, clinical or psychological, or social factors that compromise informed consent or study conduct.
    i. Those who may be allergic to treatment drugs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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