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Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.

ConditionsPancreatic Cancer MetastaticPancreatic Cancer Non-resectable
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGansu Wuwei Tumor Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 the investigator as having a high blood risk within 14 days prior to admission.

Participated in other interventional clinical trials within 30 days prior to screening.

The dose limit for organs at risk cannot reach the preset safe dose limit.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Single-armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

overall survival

overall survival（OS）

Time frame
1 year

Secondary outcomes

1

Objective tumor response rate

Objective tumor response rate(ORR)

Time frame
1 year
2

Progression-free survival

Progression-free survival (PFS)

Time frame
1year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gansu Wuwei Tumor Hospital

Lead sponsor

Source ClinicalTrials.gov
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