Metronomic Chemotherapy With Capecitabine for Pancreatic Cancer

Last updated: April 29, 2021
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Pancreatitis

Pancreatic Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT03959150
Metro-PC
  • Ages 18-75
  • All Genders

Study Summary

The latest guidelines recommend Gemcitabine plus Capecitabine as the first choice of adjuvant chemotherapy for pancreatic cancer patients in good physical condition. In order to prolong the survival of patients and improve the cure rate, metronomic chemotherapy with capecitabine is a safe, effective and economical treatment mode after adjuvant chemotherapy. This study is trying to determine that compared with observation group, if capecitabine metronomic medication is a better choice after adjuvant chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed pancreatic invasive ductal adenocarcinoma.
  2. The patient underwent surgery for pancreatic tumor resection, and no gross residuallesions were found postoperatively (R2).
  3. Stage II/III pancreatic cancer was determined according to AJCC/UICC TNM stage eighth.
  4. At least 6 cycles of gemcitabine plus capecitabine chemotherapy have been completed.
  5. Age 18-70 years old, gender not limited.
  6. ECOG performance score is 0 or 1.
  7. Without dysphagia, able to tolerate oral administration.
  8. No relevant clinical or imaging evidence of recurrence or metastasis showing withinthe 28 days before random.
  9. Chemotherapy with capecitabine combined with gemcitabine regimen was given within 12weeks after surgery, and last chemotherapy to random time ≤ 6 weeks.
  10. Adequate bone marrow, liver, and kidney function in measurements taken within 7 daysbefore registration :
  11. 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.
  12. Serum creatinine≤ 1.5 ULN, and calculated creatinine clearance of ≥ 60 mL/min/1.73m2.
  13. 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).
  14. 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.
  15. Electrocardiogram and cardiac function were not contraindicated in chemotherapy.
  16. Women should have a negative pregnancy test, and all the patients have no planningwithin 3 years and should take contraceptive measures during treatment.
  17. Informed consent form signed.

Exclusion

Exclusion Criteria:

  1. Other pathological types of pancreatic malignancies (e.g. neuroendocrine carcinoma,large cell carcinoma, signet ring cell carcinoma, etc.).
  2. With distant metastasis or malignant pleural effusion.
  3. Pregnant and breast-feeding women.
  4. Unable to oral medication.
  5. 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.
  6. A history of transient ischemic attack, cerebrovascular accident, thrombosis, orthromboembolism (pulmonary embolism or deep venous thrombosis) within 180 days beforerandomization.
  7. Any of the following uncontrolled or severe cardiovascular disease history:
  8. Myocardial infarction occurred 180 days before randomization.
  9. Uncontrolled angina occurred within 180 days before randomization.
  10. Heart failure of class III or IV (according to New York Heart Association functionalclassification).
  11. Uncontrolled hypertension after appropriate treatment (e.g. Systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg for 24h or longer).
  12. Arrhythmias that require treatment, including pacemakers.
  13. Serious drug allergy.
  14. Uncontrolled diabetes or systemic infection.
  15. Known dihydro pyrimidine dehydrogenase (DPD) deficiency.
  16. Any other reasons the investigator considers the patient should not participate in thestudy.
  17. Without personal freedom and independent civil capacity.
  18. 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

Capecitabine (Xeloda ®) is currently the most biologically active oral fluoropyrimidine drug, and is widely used in adjuvant therapy for pancreatic cancer. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. In this study, capecitabine will be prescribed as dosage of 500mg/m2, and maintain for a whole year after the standard treatment in stage II/III pancreatic cancer patients. 1 year disease-free survival is set as the primary outcome, OS, RFS, AEs and exploratory biomarkers including effects of metronome chemotherapy on immune cells, such as NK cells, T cells, TAMs, B cells, etc are also observed as the secondary outcomes. Statistical analysis are made to see compared with observation group, whether this metronomic therapy of capecitabine ( 500mg/m2) will bring benefit to pancreatic cancer patients.

Connect with a study center

  • Department of Oncology, Ruijin Hospital

    Shanghai, 200025
    China

    Active - Recruiting

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