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New treatment option for Pancreatic Cancer Metastatic
Official title Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.
ClinicalTrials.gov ID: NCT06840067
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥18 years and ≤80 years;
- Indications: patients with locally advanced or metastatic pancreatic adenocarcinoma confirmed by histopathology or cytology (stage III - IV).
- At least one measurable lesion was present according to RECIST version 1.1 evaluation criteria.
- Suitable for one cycle of gemcitabine combined with nituzumab.
- No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer);
You likely can't join if
- Patients who have received monoclonal antibodies, EGFR-TKI therapy, anti-angiogenic drugs, and immunosuppressants within six months.
- Patients with uncontrolled, cancerous pleural effusion requiring frequent drainage, pericardial effusion, or ascites (allowing for cytological...
- Participated in other treatment clinical trials within 30 days prior to screening.
- The dose limit for organs at risk cannot reach the preset safe dose limit.
- Being on chronic steroid hormone therapy for more than 6 months (e.g., prednisone dose \> 10 mg/ day or equivalent).
- People who are allergic to the drugs or their ingredients used in this program.
See the full eligibility criteria
- Age ≥18 years and ≤80 years;
- Indications: patients with locally advanced or metastatic pancreatic adenocarcinoma confirmed by histopathology or cytology (stage III - IV).
- At least one measurable lesion was present according to RECIST version 1.1 evaluation criteria.
- Suitable for one cycle of gemcitabine combined with nituzumab.
- No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer);
- Liver function, kidney function and bone marrow function were basically normal (ALT and AST \ 9 g/dL; White blood cell count ≥3.0\ 109/L; Platelet count ≥100\ 109/L;)
- 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...
- Adequate functions of major organs;
- Predicted survival (after treatment) ≥3 months;
- Informed consent has been signed by the patient or his legal representative before radiotherapy.
- Patients who have received monoclonal antibodies, EGFR-TKI therapy, anti-angiogenic drugs, and immunosuppressants within six months.
- 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...
- Participated in other treatment clinical trials within 30 days prior to screening.
- The dose limit for organs at risk cannot reach the preset safe dose limit.
- Being on chronic steroid hormone therapy for more than 6 months (e.g., prednisone dose \> 10 mg/ day or equivalent).
- People who are allergic to the drugs or their ingredients used in this program.
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation
- Persons with AIDS, including those who have received antiretroviral therapy; Active stage of syphilis;
- Accompanied by serious comorbiditions, including uncontrolled systemic or co-existing diseases (pulmonary insufficiency, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), drug or alcohol abuse, dependence...
- Patients with poor compliance, including those who may not be able to complete the treatment plan or receive prescribed follow-up and examination;
- Patients had other malignant neoplasms (except cured skin cancer and stage 0 cervical cancer);
- There are contraindications to radiotherapy;
- having no or limited capacity for civil conduct;
- Any medical history that, in the investigator's judgment, might interfere with the trial results or increase the patient's risk;
- 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...
- Inability to understand the purpose of treatment or unwillingness/inability to sign treatment consent.
The study team makes the final eligibility decision.
Where it's taking place
- Wuwei, Gansu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuwei, Gansu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.