Combining chemotherapy with an anti-PD-1 antibody for pancreatic cancer treatment
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
This study is testing if adding an anti-PD-1 antibody to standard chemotherapy can help people with pancreatic cancer live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 830 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT03983057 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining modified-FOLFIRINOX chemotherapy with an anti-PD-1 antibody in patients with borderline resectable and locally advanced pancreatic cancer. Participants will be randomly assigned to receive either the chemotherapy alone or the combination treatment. The study aims to evaluate various outcomes, including response rates, recurrence-free survival, overall survival, and side effects associated with the treatments. By comparing these two approaches, the trial seeks to determine if the addition of immunotherapy can improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with pathologically confirmed pancreatic ductal adenocarcinoma who have borderline resectable or locally advanced tumors and meet specific health criteria.
Not a fit: Patients with distant metastasis or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could significantly improve survival rates and quality of life for patients with pancreatic cancer.
How similar studies have performed: Previous studies have shown promising results with similar combination therapies in other cancer types, but this specific approach in pancreatic cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- the First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Tingbo Liang, MD PhD
- Email: liangtingbo@zju.edu.cn
- Phone: 8613666676128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.