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

Naval Military Medical University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Locally Advanced and Metastatic Pancreatic Cancer

Treatments: Combination Product: GP; Drug: PD-L1/CTLA4 BsAb; Combination Product: FOLFIRINOX

Study type: Interventional

Funder types: Other

Identifiers

NCT04324307

ChanghaiH-PP05

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

PD-L1/CTLA4 BsAb

Experimental group

Description:

For 2nd line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W

Treatment:

Drug: PD-L1/CTLA4 BsAb

PD-L1/CTLA4 BsAb + GP

Experimental group

Description:

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

Treatment:

Combination Product: GP

Drug: PD-L1/CTLA4 BsAb

PD-L1/CTLA4 BsAb + FOLFIRINOX

Experimental group

Description:

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

Treatment:

Combination Product: FOLFIRINOX

Drug: PD-L1/CTLA4 BsAb