Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nimotuzumab combined with chemoradiotherapy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer Non-resectable. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Single-arm Study of Nimotuzumab Combined With Radiotherapy and Chemotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer
Overview
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).
Detailed description
1\. Radiotherapy: Conventional fractionated radiotherapy or SBRT can be selected.
1. Conventional Fractionated Radiotherapy: Pancreatic tumor + 5mm PTV 50-60Gy/25 fractions/5W; Pancreatic tumor GTV 60-70Gy/25 fractions/5W; If there are suspected metastatic lymph node regions, prophylactic irradiation of lymph node drainage areas should be performed. 2. Stereotactic Body Radiotherapy (SBRT): Pancreatic tumor + 5mm PTV 30Gy/5 fractions/5 days; Pancreatic tumor GTV 40Gy/5 fractions/5 days.
2\. Nintuzumab: Nintuzumab 400mg, intravenous infusion, on day 1, administered once a week (QW). Mix400 mg of nintuzumab injection with 250ml of sodium chloride solution, and the infusion time should be more than 60 minutes. Administer concurrently during radiotherapy and discontinue use after radiotherapy.
3\. Chemotherapy (either tegafur or capecitabine, choose one):
1. Tegafur-gimeracil-oteracil (S-1): 80-120mg per day, taken twice a day, from day 1 to day 14, and from day 21 onwards. One treatment cycle consists of 21 days. 2. Capecitabine: 2000mg per square meter per day, taken twice a day, from day 1 to day 14, and from day 21 onwards. One treatment cycle consists of 21 days.
Continue the treatment until the disease progresses or an intolerable toxic reaction occurs.
Interventions
- Drug 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.
Primary outcome measures
- LCR [Time frame: The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy]
Secondary outcome measures (2)
- OS [Time frame: The survival rates for 1 year, 2 years, and 5 years]
- PFS [Time frame: Every 3 months]
Eligibility criteria
Inclusion criteria
- Confirmed by histological or cytological examination as pancreatic adenocarcinoma;
- Confirmed by imaging as locally advanced or oligometastatic (number of metastatic lesions ≤ 3);
- Evaluated by the clinical doctor as inoperable or the patient refuses surgery;
- ECOG PS score 0-1;
- No radiotherapy has been performed on the upper abdomen before, and no any palliative chemotherapy or other systemic anti-tumor treatment has been received;
- According to the RECIST 1.1 evaluation criteria, there are measurable lesions;
- Sufficient organ and bone marrow functions
Exclusion criteria
- Previous history of abdominal radiotherapy.
- Those with a history of other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
- Those allergic to the drugs or their components used in this protocol.
- Those with known HIV or syphilis infection, or currently in the active stage of hepatitis (hepatitis B or hepatitis C).
- Those who have undergone major surgery within 30 days before screening.
- Those who have used EGFR monoclonal antibody or EGFR-TKI within 30 days before screening.
- Pregnant or lactating women.
- Those judged by the investigator to have other reasons unsuitable for participating in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Radiotherapy Oncology, Peking University First Hospital — Beijing
Identifiers
NCT: NCT07386704 · PRO-A