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

Last updated: October 25, 2024
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Not Recruiting

Phase

2

Condition

Digestive System Neoplasms

Treatment

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

Clinical Study ID

NCT06662006
24-OBU-JS-PanC-II-015
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 75 years, ECOG score of ≤2 points, expected survival time ≥ 3months.

  2. Patients with histologically or cytologically confirmed advanced metastaticpancreatic cancer.

  3. Imaging suggests distant measurable lesions.

  4. Failure of first-line therapy and no use of fluorouracil, irinotecan, or liposomalirinotecan 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

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 othermalignancies that have received curative therapy (at least more than 5 years priorto 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.

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: nal-IRI,5-fu,LV, benmelstobart, anlotinib
Phase: 2
Study Start date:
October 01, 2024
Estimated Completion Date:
December 31, 2027

Study Description

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