Clinical trial · Interventional
SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer
A Prospective, Multicenter, Single Arm Study of SBRT Combined With Nimotuzumab and Mono-chemotherapy in the Treatment of Locally Advanced Pancreatic Cancer
NCT06422156CI-TRIAL-00077302Nim-PC-28unknownPhase 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)
This is a prospective, multicenter, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of SBRT combined with Nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC).
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 |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mono-chemotherapy | Drug | — | UNRESOLVED |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Stereotactic body radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT+Nimotuzumab+ mono-chemotherapy
- description
- All eligible patients will receive SBRT combined with nimotuzumab and mono-chemotherapy.
- interventionNames
- Radiation: Stereotactic body radiation
- Drug: Nimotuzumab
- Drug: mono-chemotherapy
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
- Up to 12 months
- description
- PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age 18-75 years old, gender unlimited; * 2\. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC); * 3\. Locally advanced pancreatic cancer (according to the NCCN criteria), unresectable or surgically declined; * 4\. The maximum diameter of the primary tumor was \< 5.0cm; * 5\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * 6\. No prior radiotherapy (upper abdomen) or tumor systemic therapy; * 7\. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN; * 8\. Left ventricular ejection fraction ≥50%; * 9\. Fertile subjects are willing to take contraceptive measures during the study period; * 10\. Woman who are breastfeeding during the study period or within 150 days after the last treatment; * 11\. Survival was expected to be ≥3 months; * 12.Good compliance and signed informed consent voluntarily. Exclusion Criteria: * 1\. Tumor invasion of gastrointestinal tract; * 2\. Woman who are pregnant or breastfeeding; * 3\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years; * 4\. History of uncontrolled epilepsy, central nervous system disease, or mental disorder, which may influence the signing of informed consent or affect the patient's adherence; * 5.Serious heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more, severe congestive heart failure or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the past 12 months; * 6\. Patients requiring immunosuppressive; * 7.Accompanied by active infections, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease; * 8\. Known allergy to prescription or any component of the prescription used in this study; * 9\. Immunodeficiency, including HIV infection or other acquired immunodeficiency, or a history of organ transplantation, or other immune-related disorders requiring medical intervention; * 10\. Patients with acute and chronic tuberculosis infection; * 11\. Received Chinese herbal medicines or immune-modulators for anti-tumor within 2 weeks prior to initial administration; * 12.History of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration; * 13\. Received any other form of immunosuppressive therapy within 7 days prior to the initial of study administration; * 14\. Participated in other clinical trials within 4 weeks, or received another investigational drugs or investigational device within 4 weeks prior to the initial administration; * 15.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
References
Publications (0)
Data not yet available
No reference posted for this study.