Clinical trial · Interventional
Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer
A Prospective, Single-arm Study of Nimotuzumab Combined With Radiotherapy and Chemotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer
- 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 study is a prospective, single-arm trial, aiming to enroll 30 patients with unresectable locally advanced or oligometastatic pancreatic cancer. The study will evaluate the efficacy and safety of nintedanib combined with radiotherapy and chemotherapy (gemcitabine or capecitabine monotherapy). The primary endpoint of this study is the 1-year local control rate (LCR).
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 Cancer Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab combined with chemoradiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab + chemoradiotherapy group
- interventionNames
- Drug: Nimotuzumab combined with chemoradiotherapy
Primary outcomes (1)
- measure
- LCR
- timeFrame
- The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy
- description
- Local Control Rate
Secondary outcomes (2)
- measure
- OS
- timeFrame
- The survival rates for 1 year, 2 years, and 5 years
- description
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed by histological or cytological examination as pancreatic adenocarcinoma; 2. Confirmed by imaging as locally advanced or oligometastatic (number of metastatic lesions ≤ 3); 3. Evaluated by the clinical doctor as inoperable or the patient refuses surgery; 4. ECOG PS score 0-1; 5. No radiotherapy has been performed on the upper abdomen before, and no any palliative chemotherapy or other systemic anti-tumor treatment has been received; 6. According to the RECIST 1.1 evaluation criteria, there are measurable lesions; 7. Sufficient organ and bone marrow functions Exclusion Criteria: 1. Previous history of abdominal radiotherapy. 2. Those with a history of other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ). 3. Those allergic to the drugs or their components used in this protocol. 4. Those with known HIV or syphilis infection, or currently in the active stage of hepatitis (hepatitis B or hepatitis C). 5. Those who have undergone major surgery within 30 days before screening. 6. Those who have used EGFR monoclonal antibody or EGFR-TKI within 30 days before screening. 7. Pregnant or lactating women. 8. Those judged by the investigator to have other reasons unsuitable for participating in this study.
References
Publications (0)
Data not yet available