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

Locally Advanced and Metastatic Pancreatic Cancer Clinical Trial

Official title:

Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04324307
• Other study ID #: ChanghaiH-PP05
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 26, 2019
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: Shiwei Guo, Doctor
• Phone: 86-18621500666
• Email: gestwa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Locally Advanced and Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• PD-L1/CTLA4 BsAb
PD-L1/CTLA4 BsAb 5mg/kg, iv,Q2W

Combination Product:
• 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;

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	objective response rate	2 years
Secondary	DCR	Disease Control Rate	2 years
Secondary	DOR	Duration of Response	2 years
Secondary	TTP	Time to Response	2 years
Secondary	PFS	Progression Free Survival	2 years
Secondary	OS	Overall Survival	2 years