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

STATUS

Recruiting
End date

Apr 1, 2024
participants needed

830
sponsor

Zhejiang University

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Updated on 9 February 2022

See if I qualify

platelet count

monoclonal antibodies

obstruction

metastasis

neutrophil count

cancer chemotherapy

adenocarcinoma

biliary obstruction

pdac

folfirinox

pancreatic ductal adenocarcinoma

breast ductal carcinoma

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.

Details

Condition	Pancreatic Cancer
Treatment	Anti-PD-1 monoclonal antibody
Clinical Study Identifier	NCT03983057
Sponsor	Zhejiang University
Last Modified on	9 February 2022

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Eligibility		Yes	No	Not Sure
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

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