Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

Last updated: August 31, 2023
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Digestive System Neoplasms

Treatment

PD-L1/CTLA4 BsAb

FOLFIRINOX

GP

Clinical Study ID

NCT04324307
ChanghaiH-PP05
  • Ages 18-80
  • All Genders

Study Summary

To evaluate the efficacy of PD-L1/CTLA4 BsAb for the second line treatment and the combination with chemotherapy for the first line treatment in pancreatic cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histology or cytology confirmed as pancreatic ductal adenocarcinoma;
  • ECOG 0-1;
  • adequate organ function (absolute neutrophil count ≥1.5 x 109/L; platelet count ≥100 x 109/L; creatinine < 1.5 x ULN (upper normal) or calculated creatinine clearance (CRCI) ≥ 60mL/min; albumin ≥ 30g/L; total bilirubin <1.5 x ULN; aspartateaminotransferase (AST) < 2.5 x ULN; alanine aminotransferase (ALT) < 2.5x ULN; INR orPT < 1.5x ULN, and aPTT <1.5x ULN);
  • no obvious symptoms of jaundice and ascites;
  • no other serious underlying diseases

Exclusion

Exclusion Criteria:

  • patients with active brain metastases;
  • history of autoimmune diseases, or need to be treated with corticosteroids andimmunosuppressive agents;
  • past history of unstable angina, symptomatic congestive heart failure, severearrhythmia, myocardial infarction within 6 months, QT interval prolongation (>450ms);
  • other malignant tumors within the last 5 years;
  • pregnant or lactating women;
  • NRS ≥ 4 points;
  • unintentional weight loss ≥ 5% within 1 month before the first dose even if peripheralor central vein nutrition support,

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: PD-L1/CTLA4 BsAb
Phase: 1/2
Study Start date:
November 26, 2019
Estimated Completion Date:
November 30, 2023

Study Description

Subjects who signed the informed consent were assigned to three cohorts according to the actual treatment status. Cohort 1 enrolled subjects receiving PD-L1/CTLA4 BsAb 5mg/kg iv Q2W for 2nd treatment; cohort 2 enrolled subjects receiving PD-L1/CTLA4 BsAb in combination with gemcitabine/albumin- paclitaxel as 1st treatment for 4-6 cycles with PD-L1/CTLA4 BsAb monotherapy maintainence; cohort 3 enrolled subjects received systemic chemotherapy, receiving PD-L1/CTLA4 BsAb combined with oxaliplatin / irinotecan / leucovorin / fluorouracil (FOLFIRINOX) as 1st treatment for 4-6 cycles withPD-L1/CTLA4 BsAb monotherapy maintainence; until disease progression according to RECIST 1.1, intolerable toxicity, withdrawal, death, 2-yr treatment,who comes first.

Connect with a study center

  • Changhai hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.