Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
NCT ID: NCT04324307
Last Updated: 2023-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2019-11-26
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PD-L1/CTLA4 BsAb
For 2nd line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W
PD-L1/CTLA4 BsAb
PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W
PD-L1/CTLA4 BsAb + GP
For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Gemcitabine 1000 mg/m2 and Nab-paclitaxel 125 mg/m2 , 28days/cycle
PD-L1/CTLA4 BsAb
PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W
GP
Gemcitabine 1000mg/m2, iv, D1,8,15, 28days/cycle; nab-Paclitaxel 125mg/m2，iv，D1,8,15, 28days/cycle;
PD-L1/CTLA4 BsAb + FOLFIRINOX
For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Oxaliplatin 68 or 85 mg/m2, Irinotecan 135 or 150 or 180 mg/m2, Calcium Folate 400 mg/m2, Fluorouracil 2400mg/m2, 14 days/cycle
PD-L1/CTLA4 BsAb
PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W
FOLFIRINOX
Fluorouracil 2400mg/m2，iv，D1, 14days/cycle; Oxaliplatin 68-85mg/m2，iv, D1,14days/cycle;Irinotecan135-180mg/m2，iv, D1, 14days/cycle;Calcium Folate 400mg/m2，iv, D1, 14days/cycle;
Interventions
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PD-L1/CTLA4 BsAb
PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W
GP
Gemcitabine 1000mg/m2, iv, D1,8,15, 28days/cycle; nab-Paclitaxel 125mg/m2，iv，D1,8,15, 28days/cycle;
FOLFIRINOX
Fluorouracil 2400mg/m2，iv，D1, 14days/cycle; Oxaliplatin 68-85mg/m2，iv, D1,14days/cycle;Irinotecan135-180mg/m2，iv, D1, 14days/cycle;Calcium Folate 400mg/m2，iv, D1, 14days/cycle;
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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,
18 Years
80 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Guo ShiWei
professor
Principal Investigators
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Gang Jin, Doctor
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Changhai hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ChanghaiH-PP05
Identifier Type: -
Identifier Source: org_study_id
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