Stage ?A Pancreatic Cancer Clinical Trial
Official title:
A Prospective, Multi-centric, Phase Ⅲ, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine (AG) Versus Oxaliplatin Plus Folinic Acid and Fluorouracil (OFF) for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection
The purpose of this study is to investigate the activity and safety of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and fluorouracil (OFF) for gemcitabine-refractory pancreatic cancer after curative resection.
PRIMARY OBJECTIVES:
- To evaluate the therapeutic efficacy of second-line adjuvant therapy with
nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and
fluorouracil (OFF) in terms of overall survival for gemcitabine-refractory pancreatic
cancer after curative resection.
SECONDARY OBJECTIVES:
- To evaluate the therapeutic efficacy of two regimens in terms of objective response
rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- To evaluate the time to remission of patients treated with the two regimens.
- To evaluate the progression-free survival of patients treated with the two regimens.
- To evaluate the levels of tumor biomarkers in serum of patients treated with the two
regimens, including Carbohydrate Antigen
(CA)19-9、CA125、CA153、CA242、CA72-4、CA50、CEA、AFP.
- To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer
Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 4.0 in
patients treated with the two regimens.
- To evaluate the quality of life score of patients treated with the two regimens.
Detailed Description of Arms:
Patients are randomized to 1 of 2 treatment arms (Arm AG or Arm OFF). Arm AG: Firstly,
patients receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3
weeks, followed by one week without treatment. Secondly, patients receive gemcitabine 1000
mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without
treatment. Treatment repeats until there is disease progression or recurrence.
Arm OFF: Patients receive oxaliplatin 85 mg/m^2 (iv, 2 hours) on days 8 and 22 with 42 days
as a cycle. Patients receive folinic acid 200 mg/m^2 (iv) and fluorouracil 2000 mg/m^2 (iv,
24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment.
Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on
the same days. Treatment repeats until there is disease progression or recurrence.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment