Nimotuzumab combined with chemoradiotherapy: The patient received treatment with nimotuzumab combined with radiotherapy and chemotherapy. The radiotherapy could be conducted using conventional fractionated radiotherapy or SBRT, and the chemotherapy could be carried out using tegafur or capecitabine.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
LCR — The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy Local Control Rate
Trial sites (1)
Facility
City
Region
Status
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing
Beijing Municipality
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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