Study Of Immunotherapy Combined With Chemotherapy In Locally Advanced And Metastatic Pancreatic Cancer

Study Overview

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

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

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.

Locally Advanced and Metastatic Pancreatic Cancer

DRUG: PD-L1/CTLA4 BsAb
COMBINATION_PRODUCT: GP
COMBINATION_PRODUCT: FOLFIRINOX

ChanghaiH-PP05

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-01-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-08-31
First Submitted that Met QC Criteria 2020-03-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-09-01
First Posted (ACTUAL) 2020-03-27	Results First Posted N/A	Last Verified 2023-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PD-L1/CTLA4 BsAb For 2nd line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W	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; COMBINATION_PRODUCT: 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;
EXPERIMENTAL: 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	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;
EXPERIMENTAL: 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	DRUG: PD-L1/CTLA4 BsAb PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W COMBINATION_PRODUCT: 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;

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: PD-L1/CTLA4 BsAb

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

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;

COMBINATION_PRODUCT: 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;

EXPERIMENTAL: 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

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;

EXPERIMENTAL: 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

DRUG: PD-L1/CTLA4 BsAb

PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W

COMBINATION_PRODUCT: 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;

Primary Outcome Measures	Measure Description	Time Frame
ORR	objective response rate	2 years

Secondary Outcome Measures	Measure Description	Time Frame
DCR	Disease Control Rate	2 years
DOR	Duration of Response	2 years
TTP	Time to Response	2 years
PFS	Progression Free Survival	2 years
OS	Overall Survival	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shiwei Guo, Doctor

Phone Number: 86-18621500666

Email: gestwa@163.com

Study Contact Backup

Name: Suizhi Gao, Doctor

Phone Number: 86-13167137990

Email: gaosuizhi@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Gang Jin, Doctor, Changhai Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record