RecruitingPhase 2NCT06662006

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

Efficacy and Safety of Second-line Therapy by Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT in Metastatic Pancreatic Cancer Patients: a Prospective, Multicentre, Single-arm, Multi-cohort Study


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

56 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy drugs, an immunotherapy drug (a PD-L1 inhibitor that helps the immune system fight cancer), and a targeted therapy that cuts off the blood supply to tumors, with or without a focused radiation technique (SBRT), as a second-line treatment for advanced pancreatic cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced pancreatic cancer that has spread to other parts of the body - Your cancer has gotten worse after first-line treatment, and that treatment did not include certain chemotherapy drugs (fluorouracil or irinotecan) - Your blood counts and organ function tests are within acceptable ranges **You may NOT be eligible if...** - You have already received second-line or later cancer treatments - Your first-line treatment included fluorouracil, irinotecan, or liposomal irinotecan - You have a history of another cancer (unless it was treated and cured more than 5 years ago) - You have a serious active infection, HIV, hepatitis, or an uncontrolled heart or brain condition - You have an autoimmune disease requiring immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGnal-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


Locations(1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06662006