Pancreatic cancer
Conditions
Interventions
Experimental group:It is planned to enroll 60 patients with locally advanced pancreatic cancer who meet the inclusion criteria and do not meet any exclusion criteria, and whose disease has been assess
Control group:It is planned to enroll 60 patients with locally advanced pancreatic cancer who meet the inclusion criteria and do not meet any exclusion criteria, and who have been assessed as non-prog
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old, gender not limited; 2. Diagnosed as pancreatic cancer through biopsy and pathological examination of the primary tumor; 3. Voluntarily accept the standard conversion treatment protocol, and after 3 cycles of treatment, the imaging assessment shows non-progression (PR or SD); 4. Locally advanced pancreatic cancer (more than 180° surrounding important blood vessels such as the abdominal trunk, superior mesenteric artery, superior mesenteric vein, and portal vein), which is considered unresectable after MDT discussion; 5. Has not received any palliative chemotherapy (those who have stopped neoadjuvant or adjuvant chemotherapy for more than half a year can be included) or other systemic anti-tumor treatments in the past; 6. According to the evaluation criteria of RECIST version 1.1, it has measurable lesions; 7. The subjects have sufficient organ and bone marrow functions: hemoglobin >=9.0 g/dL; Neutrophil count >=1.5×10^9/L; Platelet count >=100×10^9/L; Total bilirubin (TBIL) 60 mL/min(using the Cockcroft-Gault formula) : For females, CrCl=(140- age)× weight (kg)× 0.85 / (72×Scr mg/dl); for males, CrCl=(140- age)× weight (kg)× 1.00 / (72×Scr mg/dl) 8.ECOG PS score 0-1; 9. Life expectancy is at least 3 months; 10. Patients of childbearing age and their spouses are willing to take contraceptive measures; 11. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Refuse to undergo systemic chemotherapy or possible surgery; 2) There are metastases in other sites (such as the liver, peritoneum, lungs, bones or brain); 3) Those with a history of other malignant tumors (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4) Accompanied by other serious diseases, including but not limited to: a) Uncontrollable congestive heart failure (NYHA classification III or IV, see Annex III), unstable angina pectoris, poorly controlled arrhythmia, and uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg) b) Active infection; c) Uncontrolled diabetes; d) There is uncontrollable pleural effusion, pericardial effusion or ascites that requires drainage; e) Severe portal hypertension or imaging manifestations of cavernous changes in the portal vein; f) Gastric outlet obstruction; g) Respiratory insufficiency (requiring oxygen inhalation); 5) Having undergone major surgery within 30 days prior to screening; 6) Have used EGFR monoclonal antibodies or EGFR-Tkis within 30 days prior to screening; 7) Those who are allergic to the drugs or their components used in this plan; 8) Known or self-reported history of HIV infection or chronic hepatitis B or C; 9) There is any unresolved CTCAE grade 2 or above toxicity caused by previous treatments (excluding anemia, alopecia, skin pigmentation and chemotherapy-induced neurotoxicity); 10) There are other reasons that the researcher deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Objective response rate (ORR);Quality of life (QoL);Tumor markers;Complications within 30 days after surgery;Postoperative 30-day complication rate;Safety; | — |
Countries
China
Contacts
Public ContactLi Huikai
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed