Combining immunotherapy and chemotherapy for advanced pancreatic cancer
Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
This study is testing a new antibody treatment alone or with chemotherapy to see if it can help people with advanced pancreatic cancer feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04324307 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a novel PD-L1/CTLA4 bispecific antibody (BsAb) in treating locally advanced and metastatic pancreatic cancer. Participants are assigned to one of three cohorts based on their treatment status, receiving either the BsAb alone or in combination with standard chemotherapy regimens such as gemcitabine or FOLFIRINOX. The treatment continues until disease progression, intolerable toxicity, or other specified endpoints are reached. The study aims to assess both the safety and efficacy of these treatment combinations.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed pancreatic ductal adenocarcinoma and good overall health as indicated by an ECOG score of 0-1.
Not a fit: Patients with active brain metastases or serious underlying diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced pancreatic cancer.
How similar studies have performed: Other studies have shown promise in combining immunotherapy with chemotherapy for various cancers, suggesting potential success for this novel approach in pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histology or cytology confirmed as pancreatic ductal adenocarcinoma; * ECOG 0-1; * adequate organ function (absolute neutrophil count ≥1.5 x 109/L; platelet count ≥100 x 109/L; creatinine \< 1.5 x ULN (upper normal) or calculated creatinine clearance ( CRCI) ≥ 60mL/min; albumin ≥ 30g/L; total bilirubin \<1.5 x ULN; aspartate aminotransferase (AST) \< 2.5 x ULN; alanine aminotransferase (ALT) \< 2.5x ULN; INR or PT \< 1.5x ULN, and aPTT \<1.5x ULN); * no obvious symptoms of jaundice and ascites; * no other serious underlying diseases Exclusion Criteria: * patients with active brain metastases; * history of autoimmune diseases, or need to be treated with corticosteroids and immunosuppressive agents; * past history of unstable angina, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction within 6 months, QT interval prolongation (\>450ms); * other malignant tumors within the last 5 years; * pregnant or lactating women; * NRS ≥ 4 points; * unintentional weight loss ≥ 5% within 1 month before the first dose even if peripheral or central vein nutrition support,
Where this trial is running
Shanghai, Shanghai
- Changhai hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Gang Jin, Doctor — Changhai Hospital
- Study coordinator: Shiwei Guo, Doctor
- Email: gestwa@163.com
- Phone: 86-18621500666
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.