Carbon ion radiotherapy for pancreatic cancer treatment

Single-arm Clinical Study of Carbon Ion Radiotherapy Combined with Nituzumab and Gemcitabine for Pancreatic Cancer.

This study is testing a new treatment using carbon ion radiotherapy along with two other drugs to see if it can help people with advanced pancreatic cancer live longer and have fewer side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Gansu Wuwei Tumor Hospital (Academic / other)
• Drugs / interventions: nituzumab, prednisone, chemotherapy, radiation
• Locations: 1 site (Wuwei, Gansu)
• Trial ID: NCT06840067 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine for patients with locally advanced and metastatic pancreatic cancer. It is a single-center, single-arm, prospective Phase II trial that includes patients aged 18 to 80 with confirmed pancreatic ductal adenocarcinoma deemed inoperable. The primary endpoint is progression-free survival, and all participants will be monitored for at least 12 months. The study aims to improve tumor control while minimizing damage to surrounding healthy tissue.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed inoperable pancreatic ductal adenocarcinoma.

Not a fit: Patients with other active malignancies or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced pancreatic cancer.

How similar studies have performed: While carbon ion therapy is a novel approach, similar studies have shown promising results in treating other types of cancers.

Eligibility criteria

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.

Where this trial is running

Wuwei, Gansu

• Heavy Ion Radiotherapy Department — Wuwei, Gansu, China (Recruiting)

Study contacts

• Study coordinator: Xiaojun Li

Conditions Pancreatic Cancer Metastatic; Pancreatic Cancer Non-resectable; Carbon Ion Radiotheray; pancreatic cancer; Nimotuzumab; Gemcitabine