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

  • STATUS
    Recruiting
  • End date
    Nov 16, 2023
  • participants needed
    60
  • sponsor
    Changhai Hospital
Updated on 2 March 2022

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

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.

Details
Condition Locally Advanced and Metastatic Pancreatic Cancer
Treatment FOLFIRINOX, PD-L1/CTLA4 BsAb, GP, GP
Clinical Study IdentifierNCT04324307
SponsorChanghai Hospital
Last Modified on2 March 2022

Eligibility

Yes No Not Sure

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; aspartate aminotransferase (AST) < 2.5 x ULN; alanine aminotransferase (ALT) < 2.5x ULN; INR or PT < 1.5x ULN, and aPTT <1.5x ULN)
no obvious symptoms of jaundice and ascites
no other serious underlying diseases

Exclusion Criteria

patients with active brain metastases
history of autoimmune diseases, or need to be treated with corticosteroids and immunosuppressive agents
past history of unstable angina, symptomatic congestive heart failure, severe arrhythmia, 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 peripheral or central vein nutrition support
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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