This study is a multicenter, single-arm, phase II exploratory study, aims to evaluate the efficacy and safety of metronomic capecitabine with camrelizumab and apatinib mesylate in advanced pancreatic cancer after the failure of first-line treatment.
1: Age is 18 years or older; 2: Pathologically confirmed pancreatic adenocarcinoma; 3: As determined by the investigator, second-line treatment for advanced pancreatic cancer has failed; or the patient has a poor performance status (PS score >1), and the investigator considers that the patient cannot tolerate a second-line regimen with two or more drugs.
1: Patients who have developed resistance after treatment with capecitabine and apatinib are not recommended for enrollment unless more than 6 months have passed since the last dose, in which case they can continue to challenge its use; patients who have previously undergone immunotherapy (regardless of whether or not they used camrelizumab) can cross-line use or switch to camrelizumab to continue challenging its use.
Single group
Metronomic capecitabine
DrugMetronomic capecitabine: 650 mg/m2, twice daily, to be swallowed with water within 30 minutes after a meal;
Camrelizumab
DrugCamrelizumab: a PD-1 inhibitor, 200 mg, intravenous injection once every 2 weeks;
Apatinib Mesylate Tablets
DrugApatinib mesylate: a small molecule of tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2) , 250mg, once daily, to be swallowed with water within 30 minutes after a meal.
Objective Response Rate (ORR)
The proportion of patients who had tumor evaluated as CR/PR according to irRECIST1.1 criteria during the whole study.
Disease Control Rate (DCR)
The proportion of patients who had tumor evaluated as CR/PR/SD according to irRECIST1.1 criteria during the whole study.
Safety of treatment
Evaluate the grading of blood test abnormalities and other adverse drug reaction according to CTCAE 5.0.
The quality of life
The EORTC QLQ-C30 scoring scale was adopted to evaluate the quality of life of patients with advanced pancreatic cancer.
Overall Survival (OS)
The time from enrolled to death due to any cause during the whole study.
Progression-free Survival (PFS)
The time from enrolled to disease progression or death due to any cause during the whole study.
Response Rate of CA199
At least one serum CA199 value decreased by 50% or more that compared with the baseline level before treatment.
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This trial is not recruiting at the moment. You can still explore other options:
