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

Study Overview

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

The prognosis of pancreatic cancer is extremely poor. NCCN 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 metastatic pancreatic cancer.

Metastatic pancreatic cancer patients will be enrolled in this trial. Investigators will assign patients to the treatment after randomization. The primary endpoint is overall survival. Response rate, progression-free survival, drugs related side effects and other endpoints events will be recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with metastatic pancreatic cancer.

Pancreatic Cancer

DRUG: Combination drug
DRUG: Chemotherapy

CISPD3

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 2023-01-25
First Submitted that Met QC Criteria 2019-06-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-01-27
First Posted (ACTUAL) 2019-06-06	Results First Posted N/A	Last Verified 2023-01

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
ACTIVE_COMPARATOR: 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	DRUG: Chemotherapy modified-FOLFIRINOX
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 200mg.	DRUG: Combination drug Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 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

DRUG: Chemotherapy

modified-FOLFIRINOX

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 200mg.

DRUG: Combination drug

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

Primary Outcome Measures	Measure Description	Time Frame
Overall survival	The period from the first study treatment to any cause of death	Through the study peirod, for 3 years

Secondary Outcome Measures	Measure Description	Time Frame
Resection rate	The number of cases received surgery / the total number of evaluable cases (%)	Through the study peirod, for 3 years
Objective response rate	The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)	Through the study peirod, for 3 years
Disease control rate	The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%)	Through the study peirod, for 3 years
Progression-free survival	The period from the first treatment to the first evaluation of PD or any cause of death	Through the study peirod, for 3 years
Adverse effects	Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.	Through the study peirod, for 3 years
Carbohydrate antigen 19-9	The change of CA 199	Through the study peirod, for 3 years
EORTC QLQ - PAN26 score	The change of the quality of life	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.

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).

Recurrent disease or metastatic disease (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.
Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy
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.
Signed informed consent.

•History of participation of other clinical trails within 4 weeks

History of autoimmune disease or other condition receiving glucocorticoid treatment
History of receiving chemotherapy within 2 weeks
History of radiotherapy and molecular target therapy within 2 weeks
History if active tuberculosis
History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
Hematological precancerous diseases, such as myelodysplastic syndromes.
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).
Immune deficiency syndrome, such as active tuberculosis and HIV infection.
Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
Severe serious wounds, ulcers or fractures.
Clinical evaluation is unacceptable

Collaborators and Investigators

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

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

Fu Q, Chen Y, Huang D, Guo C, Zhang X, Xiao W, Xue X, Zhang Q, Li X, Gao S, Que R, Shen Y, Wu J, Zhang M, Bai X, Liang T. Sintilimab Plus Modified FOLFIRINOX in Metastatic or Recurrent Pancreatic Cancer: The Randomized Phase II CISPD3 Trial. Ann Surg Oncol. 2023 Aug;30(8):5071-5080. doi: 10.1245/s10434-023-13383-w. Epub 2023 Apr 13.

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