Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.

Summary

The objective is to evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.

Interventions

• carbon ion radiotherapy (CIRT) · RADIATION

  1.CIRT: GTV: Primary tumor visible on imaging and clinical examination, and involved regional lymph nodes identified by CT/MRI (≥1.0 cm) or PET/CT scan. CTV: GTV plus 5mm margin, include posterior peritoneal plexus area and elective node irradiation around the pancreas (ENI). PTV: CTV plus 2.5-5mm margin (depending on the system error of each unit; When pancreatic head cancer is close to the stomach and intestines, the gastrointestinal direction does not expand). ITV: delineated on 4D-CT considering the influence of respiratory activity. Prescription dose: Stratification by measuring the nearest distance between PTV and gastrointestinal tract (≥5mm or \< 5mm); Pancreatic head cancer (distance \< 5mm) : 52.8Gy(RBE)/4.4Gy/12Fx; Pancreatic head, body and tail cancer (≥5mm) : 57.2Gy(RBE)/4.4Gy/13Fx. CIRT was once a day, four or five times a week. 2.Chemotherapy:Gemcitabine 1000mg/m2, intravenous infusion, dl, d8; Q3w . 3.Targeted therapyNituzumab injection 400mg, Qw，at least 4-6 cycles.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

1. Age ≥18 years and ≤80 years;
2. Indications: patients with locally advanced or metastatic pancreatic adenocarcinoma confirmed by histopathology or cytology (stage III - IV).
3. At least one measurable lesion was present according to RECIST version 1.1 evaluation criteria.
4. Suitable for one cycle of gemcitabine combined with nituzumab.
5. No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer);
6. Liver function, kidney function and bone marrow function were basically normal (ALT and AST \< 1.5 times of high normal value (ULN), bilirubin \< 1.5×ULN; Adult endogenous creatinine clearance rate of 60ml/min or serum creatinine SCR≤140μmoI/L, BUN≤6.8mmol/L; Hemoglobin level \>9 g/dL; White blood cell count ≥3.0\*109/L; Platelet count ≥100\*109/L;)
7. Good physical condition, i.e. ECOG (Eastern United States Oncology Collaboration Group) 0\~2; There were no complications such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, and severe chronic heart disease that may affect radiotherapy. Cardiac function grade 1. (According to the New York College of Cardiology Cardiac Function Scale (NYHA)
8. Adequate functions of major organs;
9. Predicted survival (after treatment) ≥3 months;
10. Informed consent has been signed by the patient or his legal representative before radiotherapy.

Exclusion Criteria:

1. Patients who have received monoclonal antibodies, EGFR-TKI therapy, anti-angiogenic drugs, and immunosuppressants within six months.
2. Patients with uncontrolled, cancerous pleural effusion requiring frequent drainage, pericardial effusion, or ascites (allowing for cytological confirmation of effusion), gastrointestinal bleeding, or those identified by the investigator as having a high blood risk within 14 days prior to admission.
3. Participated in other interventional clinical trials within 30 days prior to screening.
4. The dose limit for organs at risk cannot reach the preset safe dose limit.
5. Being on chronic steroid hormone therapy for more than 6 months (e.g., prednisone dose \> 10 mg/ day or equivalent).
6. People who are allergic to the drugs or their ingredients used in this program.
7. Pregnancy (confirmed by serum or urine β-HCG test) or lactation
8. Persons with AIDS, including those who have received antiretroviral therapy; Active stage of syphilis;
9. Accompanied by serious comorbiditions, including uncontrolled systemic or co-existing diseases (pulmonary insufficiency, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), drug or alcohol abuse, dependence, addiction, and/or mental illness that prevent the successful implementation of the trial protocol;
10. Patients with poor compliance, including those who may not be able to complete the treatment plan or receive prescribed follow-up and examination;
11. Patients had other malignant neoplasms (except cured skin cancer and stage 0 cervical cancer);
12. There are contraindications to radiotherapy;
13. having no or limited capacity for civil conduct;
14. Any medical history that, in the investigator's judgment, might interfere with the trial results or increase the patient's risk;
15. Any condition in which the physician considers that participation in the trial is not appropriate, the physician determines that the patient will not benefit from carbon ion radiotherapy, or that there are other co-existing conditions or other factors that may affect carbon ion therapy.
16. Inability to understand the purpose of treatment or unwillingness/inability to sign treatment consent.

Sites (1)

• Heavy Ion Radiotherapy Department, Wuwei, Gansu, China · RECRUITING