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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03983057
Other study ID # CISPD-4
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2019
Est. completion date December 1, 2024

Study information

Verified date June 2023
Source Zhejiang University
Contact Tingbo Liang, MD PhD
Phone 8613666676128
Email liangtingbo@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 830
Est. completion date December 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China the First Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival The time of treatment until documented tumor progreesion. Through the study peirod, for 3 years
Secondary Resection rate The proportion of patients with surgeical treatment after treatment Through the study peirod, for 3 years
Secondary R0 rate The proportion of patients with completely tumor resection after treatment Through the study peirod, for 3 years
Secondary 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
Secondary Disease control rate The proportion of patients with tumor size reduction or stable Through the study peirod, for 3 years
Secondary Overall survival The time of treatment until death. Through the study peirod, for 3 years
Secondary 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
Secondary Adverse effects The most common hematologic and non-hemotologic adverse events Through the study peirod, for 3 years
Secondary Carbohydrate antigen 19-9 Carbohydrate antigen 19-9 level Through the study peirod, for 3 years
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