Clinical trial · Interventional
Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
NCT04324307CI-TRIAL-00069279unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy of PD-L1/CTLA4 BsAb for the second line treatment and the combination with chemotherapy for the first line treatment in pancreatic cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced and Metastatic Pancreatic Cancer | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX | Combination Product | — | UNRESOLVED |
| GP | Combination Product | — | UNRESOLVED |
| PD-L1/CTLA4 BsAb | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- PD-L1/CTLA4 BsAb
- description
- For 2nd line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W
- interventionNames
- Drug: PD-L1/CTLA4 BsAb
- type
- EXPERIMENTAL
- label
- PD-L1/CTLA4 BsAb + GP
- description
- For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Gemcitabine 1000 mg/m2 and Nab-paclitaxel 125 mg/m2 , 28days/cycle
- interventionNames
- Drug: PD-L1/CTLA4 BsAb
- Combination Product: GP
- type
- EXPERIMENTAL
- label
- PD-L1/CTLA4 BsAb + FOLFIRINOX
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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,
References
Publications (0)
Data not yet available
No reference posted for this study.