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

Pancreatic Cancer Clinical Trial

Official title:

Comparison of Therapeutic Effect Between Combination of Anti-PD-1 Antibody With mFOLFIRINOX and mFOLFIRINOX Alone in Metastatic Pancreatic Cancer Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977272
• Other study ID #: CISPD3
• Status: Completed
• Phase: Phase 2
• Start date: March 27, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• •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.

Exclusion Criteria:

• •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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Combination drug
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
• Chemotherapy
modified-FOLFIRINOX

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	Overall survival	The period from the first study treatment to any cause of death	Through the study peirod, for 3 years
Secondary	Resection rate	The number of cases received surgery / the total number of evaluable cases (%)	Through the study peirod, for 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Carbohydrate antigen 19-9	The change of CA 199	Through the study peirod, for 3 years
Secondary	EORTC QLQ - PAN26 score	The change of the quality of life	Through the study peirod, for 3 years