Clinical trial · Interventional
AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer
Efficacy and Safety of AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer
NCT06080854CI-TRIAL-00070425unknownPhase 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)
The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable 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 |
|---|---|---|---|
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| SBRT | Other | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concurrent radiochemotherapy combined with immunotherapy
- description
- Participants will receive toripalimab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery.
- interventionNames
- Drug: Toripalimab
- Drug: Gemcitabine
- Drug: Nab paclitaxel
- Other: SBRT
Primary outcomes (2)
- measure
- ORR
- timeFrame
- 2 years
- description
- RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1
- measure
- R0 resection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>= 18 years; 2. Eastern Cooperative Oncology Group (ECOG) score of 0-1; 3. Pancreatic cancer confirmed by histology or cytology; 4. Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan; 5. Hematological indexes: Neutrophil count \>= 1.5 x 10\^9/L Hemoglobin \>= 10g / dl Platelet count \>= 100 x 10\^9/L; Biochemical indicators: Total bilirubin \<= 1.5 x upper limit of normal value (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 1.5 x ULN; Creatinine clearance rate \>= 60ml / min. 6. Participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test; 7. Signed informed consent; 8. Follow the protocol and follow-up procedures. Exclusion Criteria: 1. Have received systematic anti-tumor treatment. 2. Previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment). 3. Active bacterial or fungal infection (\> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0). 4. Human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group. 5. Autoimmune diseases or immune defects who are treated with immunosuppressive drugs. 6. Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group. 7. Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected. 8. Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.
References
Publications (1)
- BACKGROUNDDu J, Lu C, Mao L, Zhu Y, Kong W, Shen S, Tang M, Bao S, Cheng H, Li G, Chen J, Li Q, He J, Li A, Qiu X, Gu Q, Chen D, Qi C, Song Y, Qian X, Wang L, Qiu Y, Liu B. PD-1 blockade plus chemoradiotherapy as preoperative therapy for patients with BRPC/LAPC: A biomolecular exploratory, phase II trial. Cell Rep Med. 2023 Mar 21;4(3):100972. doi: 10.1016/j.xcrm.2023.100972. Epub 2023 Mar 7. PMID 36889321