Last updated: April 29, 2021
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting
Phase
2/3
Condition
Pancreatitis
Pancreatic Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT03959150
Metro-PC
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed pancreatic invasive ductal adenocarcinoma.
- The patient underwent surgery for pancreatic tumor resection, and no gross residuallesions were found postoperatively (R2).
- Stage II/III pancreatic cancer was determined according to AJCC/UICC TNM stage eighth.
- At least 6 cycles of gemcitabine plus capecitabine chemotherapy have been completed.
- Age 18-70 years old, gender not limited.
- ECOG performance score is 0 or 1.
- Without dysphagia, able to tolerate oral administration.
- No relevant clinical or imaging evidence of recurrence or metastasis showing withinthe 28 days before random.
- Chemotherapy with capecitabine combined with gemcitabine regimen was given within 12weeks after surgery, and last chemotherapy to random time ≤ 6 weeks.
- Adequate bone marrow, liver, and kidney function in measurements taken within 7 daysbefore registration :
- Hemoglobin ≥ 90 g/L, Platelet count ≥ 100×109/L, Absolute granulocyte count ≥ 1.5×109/L. i. Note: patients should not receive blood transfusion or growth factor support within 14 days before collection of blood samples.
- Serum creatinine≤ 1.5 ULN, and calculated creatinine clearance of ≥ 60 mL/min/1.73m2.
- AST and ALT ≤ 2.5 X ULN, serum total bilirubin ≤ 1.5 X ULN (Patients with Gilbertsyndrome with total bilirubin≤ 3 X ULN can be enrolled).
- INR or PT ≤ 1.5×ULN,unless the patient is receiving anticoagulant therapy and the PTvalue is within the expected therapeutic range of the anticoagulant.
- Electrocardiogram and cardiac function were not contraindicated in chemotherapy.
- Women should have a negative pregnancy test, and all the patients have no planningwithin 3 years and should take contraceptive measures during treatment.
- Informed consent form signed.
Exclusion
Exclusion Criteria:
- Other pathological types of pancreatic malignancies (e.g. neuroendocrine carcinoma,large cell carcinoma, signet ring cell carcinoma, etc.).
- With distant metastasis or malignant pleural effusion.
- Pregnant and breast-feeding women.
- Unable to oral medication.
- Previous or concurrent malignancies, excluding curatively treated in situ carcinoma ofthe cervix or non-melanoma skin cancer, unless at least 5 years have elapsed sincelast treatment and the patient is considered cured.
- A history of transient ischemic attack, cerebrovascular accident, thrombosis, orthromboembolism (pulmonary embolism or deep venous thrombosis) within 180 days beforerandomization.
- Any of the following uncontrolled or severe cardiovascular disease history:
- Myocardial infarction occurred 180 days before randomization.
- Uncontrolled angina occurred within 180 days before randomization.
- Heart failure of class III or IV (according to New York Heart Association functionalclassification).
- Uncontrolled hypertension after appropriate treatment (e.g. Systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg for 24h or longer).
- Arrhythmias that require treatment, including pacemakers.
- Serious drug allergy.
- Uncontrolled diabetes or systemic infection.
- Known dihydro pyrimidine dehydrogenase (DPD) deficiency.
- Any other reasons the investigator considers the patient should not participate in thestudy.
- Without personal freedom and independent civil capacity.
- Already enrolled into other clinical trials.
Study Design
Total Participants: 231
Study Start date:
January 05, 2020
Estimated Completion Date:
June 30, 2023
Study Description
Connect with a study center
Department of Oncology, Ruijin Hospital
Shanghai, 200025
ChinaActive - Recruiting

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