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

Pancreatic Cancer Clinical Trial

Official title:

Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983057
• Other study ID #: CISPD-4
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

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