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Clinical study of gold ficidual implantation of 3D printing template assisted CT-guided stereotactic radiotherapy for pancreatic cancer (FIRST-1)

Clinical study of gold ficidual implantation of 3D printing template assisted CT-guided stereotactic radiotherapy for pancreatic cancer (FIRST-1)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056881
Enrollment
Unknown
Registered
2022-02-22
Start date
2022-02-14
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic carcinoma

Interventions

Experimental group:Gold Fiducial Implantation

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Written informed consent signed by the patient or the person authorized by the patient; 2. Aged >= 18 years; 3. The patient was diagnosed as pancreatic cancer by pathology; 4. The patient was to receive stereotactic radiotherapy for pancreatic cancer; 5. Patients can tolerate anesthesia; 6. The ECOG PS score was 0-2; 7. Estimated survival time >=3 months; 8. Laboratory results during screening must meet the following requirements: (1) Blood routine: absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count (PLT) > 50 x 10^9/L, hemoglobin (HGB) >= 90 g/L (no blood transfusion or erythropoietin dependence within 7 days); (2) Liver function: total bilirubin (TBIL) =60 mL/min (Cockcroft-Gault formula), and urine routine test results showed urinary protein (UPRO) < 2+ or 24-hour urinary protein quantification <1g; (4) Within 7 days before treatment, international normalized ratio (INR) <=1.5 times ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (APTT) <=1.5 times ULN; 9. Female patients of reproductive age should have a negative urine or serum pregnancy test within 3 days prior to receiving the first study drug administration (cycle 1, day 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested; 10. Compliance with the study protocol is expected to be good.

Exclusion criteria

Exclusion criteria: 1. No suitable puncture path; 2. Patients with severe bleeding tendency, such as prothrombin time >18s, prothrombin activity <40%, and anticoagulant therapy and/or antiplatelet coagulation drugs stopped for less than 1 week before seed implantation therapy; 3. Unwell controlled serious comorbidities (such as severe hypertension, diabetes, etc.) leading to clinical risk; 4. Patients with active infectious diseases, trauma, stroke and severe trauma; 5. Patients with mental disorders; 6. Lactating patients; 7. Other researchers consider it inappropriate to be included.

Design outcomes

Primary

MeasureTime frame
safety;

Secondary

MeasureTime frame
success rate;the optimal time interval between gold fiducial implantation and CT simulation;

Countries

China

Contacts

Public ContactWang Junjie
wangjunjie_puth@163.com+86 13701076310

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026