Status:
UNKNOWN
Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
Lead Sponsor:
Changhai Hospital
Conditions:
Locally Advanced and Metastatic Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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
Detailed 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;...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
November 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04324307
Start Date
November 26 2019
End Date
November 1 2023
Last Update
September 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Changhai hospital
Shanghai, Shanghai Municipality, China, 200433