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A clinical study of precision therapy for patients with resectable pancreatic cancer with different metastatic risks

A clinical study of precision therapy for patients with resectable pancreatic cancer with different metastatic risks

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037462
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

pancreatic cancer

Interventions

Multiple groups:different treatment modes

Sponsors

Renji Hospital affiliated to Shanghai Jiao Tong University Medical College
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old male or female; 2. Preoperative imaging assessment was for patients with resectable pancreatic cancer, and intraoperative assessment was for patients with R0 radical treatment; 3. No previous systemic treatment (including chemotherapy, chemoradiotherapy, surgery and other local treatments); 4. With treatment indications and without absolute contraindications of chemotherapy; 5. The subjects voluntarily participated in this study, signed the informed consent form, had good compliance and cooperated with the follow-up; 6. ECOG PS 0-1; 7. Expected survival >=3 months; 8. The main organs are functioning normally, i.e. they meet the following criteria: (1) blood routine examination standards shall meet: (no blood transfusion within 14 days) HB 90 g/L or higher; the ANC acuity 1.5 x 10^9/L; PLT acuity 80 x 10^9/L; (2) Biochemical examination shall meet the following standards: TBIL 50ml/min (Cockcroft-Gault formula); 9. Women of childbearing age must have a pregnancy test (serum) that is negative within 7 days of enrolment and be willing to use an appropriate method of contraception during the test and 8 weeks after the last dose of the test drug; For men, surgical sterilization should be performed, or an appropriate method of contraception should be agreed during the trial and 8 weeks after the last dose of the experimental drug; 10. Written informed consent was signed prior to trial screening.

Exclusion criteria

Exclusion criteria: 1. Tumor R1 resection; 2. Preoperative imaging indicated lymph node metastasis in 16 groups; 3. Postoperative pathology confirmed non-pancreatic cancer; 4. With severe cardiovascular disease and poor control, including but not limited to: ? magnitude myocardial ischemia or poor control of myocardial infarction, arrhythmia (including QTc interphase male 450, female 470 ms or ms or higher);According to NYHA standard, ? ~ ? cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) < 50%; 5. Patients with a history of other tumors; 6. Persons with a history of abuse of psychotropic substances and unable to quit or with mental disorders; 7. Patients who have participated in clinical trials of other drugs within 4 weeks; 8. Patients with other concomitant diseases that, at the discretion of the investigator, seriously endanger the safety of the patient or affect the completion of the study; 9. Pregnant or lactating women; 10. The researcher thinks that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
overall survival;

Countries

China

Contacts

Public ContactWEI LIU

Renji Hospital affiliated to Shanghai Jiao Tong University Medical College

sugliuwei2004@126.com+86 13916969984

Outcome results

None listed

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