Combination Of Anti-PD-1 Antibody And Chemotherapy In Pancreatic Cancer

Study Overview

Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with borderline resectable and locally advanced pancreatic cancer.

Investigators chose borderline resectable and locally advanced pancreatic cancer patients. The planned treatment was given to the participants after randomization. Response rate, recurrence-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with borderline resectable and locally advanced pancreatic cancer.

Pancreatic Cancer

DRUG: Anti-PD-1 monoclonal antibody

CISPD-4

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 2019-06-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-06-12
First Submitted that Met QC Criteria 2019-06-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-06-13
First Posted (ACTUAL) 2019-06-12	Results First Posted N/A	Last Verified 2023-06

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:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
NO_INTERVENTION: Chemotherapy group Treatment with modified-FOLFIRINOX Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
EXPERIMENTAL: Combination group Treatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2, Anti-PD-1 antibody 3mg/kg	DRUG: Anti-PD-1 monoclonal antibody Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.

Participant Group/Arm

Intervention/Treatment

NO_INTERVENTION: Chemotherapy group

Treatment with modified-FOLFIRINOX Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2

EXPERIMENTAL: Combination group

Treatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2, Anti-PD-1 antibody 3mg/kg

DRUG: Anti-PD-1 monoclonal antibody

Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.

Primary Outcome Measures	Measure Description	Time Frame
Progression-free survival	The time of treatment until documented tumor progreesion.	Through the study peirod, for 3 years

Secondary Outcome Measures	Measure Description	Time Frame
Resection rate	The proportion of patients with surgeical treatment after treatment	Through the study peirod, for 3 years
R0 rate	The proportion of patients with completely tumor resection after treatment	Through the study peirod, for 3 years
Objective response rate	The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period	Through the study peirod, for 3 years
Disease control rate	The proportion of patients with tumor size reduction or stable	Through the study peirod, for 3 years
Overall survival	The time of treatment until death.	Through the study peirod, for 3 years
EORTC QLQ - PAN26 score	QLQ score assessed by the European Organization for Research and Treatment of Cancer Quality of Life scale for pancreatic cancer	Through the study peirod, for 3 years
Adverse effects	The most common hematologic and non-hemotologic adverse events	Through the study peirod, for 3 years
Carbohydrate antigen 19-9	Carbohydrate antigen 19-9 level	Through the study peirod, for 3 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: Tingbo Liang, MD PhD

Phone Number: 8613666676128

Email: liangtingbo@zju.edu.cn

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:

Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
Initial assessment for definitive borderline resectable or locally advanced tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2019 first edition standard).
ECOG score 0 or 1.
Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
ALT and AST are less than 2 x ULN.
If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.
Leukocyte count (> 3.5 x 10^6 /mL), neutrophil count (> 1.5 x 10^6 /mL), platelet count (> 80 x 10^6 /mL), hemoglobin (> 9 g/dL).
Signed informed consent.

History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
History of participation of other clinical trails within 4 weeks
History of immunotherapy within 4 weeks
History of receiving chemotherapy, radiotherapy and molecular target therapy within 2 weeks
Tumor is a local recurrent lesion.
Imaging confirmed severe portal hypertension / cavernous transformation.
Ascites
Gastric outlet obstruction
Respiratory failure requires supplementation of oxygen.
Immune deficiency syndrome, such as active tuberculosis and HIV infection.
Hematological precancerous diseases, such as myelodysplastic syndromes.
Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
Preexisting neuropathy > 1 (NCI CTCAE).
Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
Severe serious wounds, ulcers or fractures.
Confirmed coagulant disease.
Clinical evaluation is unacceptable.

Collaborators and Investigators

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

Publications

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