Status:
UNKNOWN
Apatinib, Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After AG Regimen
Lead Sponsor:
Fudan University
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of apatinib combined with irinotecan and S-1 (ApaIRIS) in treating Patients with metastatic pancreatic canc...
Detailed Description
While AG (albumin-bound paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after AG regimen...
Eligibility Criteria
Inclusion
- Informed consent and willing to complete the study according to the protocol
- ECOG performance scale ≤ 2;
- Diagnosed as pancreatic adenocarcinoma by histology and cytology;
- Treatment of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen
- Baseline blood routine and biochemical indexes meet the following criteria:
- Blood routine examination criteria must be met: (no blood transfusion within 14 days)
- HB≥90g/L；
- ANC≥1.5×109/L；
- PLT≥80×109/L
- Biochemical tests are subject to the following criteria:
- BIL \<1.25xULN ；
- ALT and AST\<2.5ULN；
- Serum creatinine. Less than 1 times the upper limit of normal value, Endogenous creatinine clearance\>50ml/min ( Cockcroft-Gault formula).
- The advanced pancreatic cancer pathology, with measurable lesions (spiral CT scan is more than 10 mm, according to the standard of RECIST 1.1);
- Life expectancy ≥ 12 weeks;
- Doctors believe that treatment can bring benefits to patients.
Exclusion
- unwilling or unable to comply with the study protocol;
- Other or malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- Allergy to apatinib, S-1 raw materials and/or their excipients;
- Received VEGFR inhibitors, such as sorafenib, chougny for treatment;
- Have high blood pressure and antihypertensive drug treatment can not drop to normal range(systolic pressure \>140 mmHg, diastolic blood pressure 90\>mmHg);
- Suffering from coronary artery disease above grade I, grade I arrhythmia (including corrected QT interval prolongation male \> 450 ms, women \> 470 MS) and grade I heart insufficiency; urine protein positive patients.
- Renal insufficiency, patients with previous kidney disease, urine protein positive (urinary protein detection 2+ or above, or 24-hour urine protein quantitation \> 1.0g);
- Has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.)
- Pregnant or lactating women;
- Coagulant function abnormality (INR\>1.5、APTT\>1.5 ULN) with bleeding tendency; Those with bleeding tendency (such as active ulcerative lesions in the stomach, fecal occult blood (++), vaginal and/or hematemesis within 3 months, hemoptysis) or lesions close to the large vessel site;
- Patients with a deficiency of dihydropyrimidine dehydrogenase are known;
- Evidence of any severe or uncontrolled systemic disease (eg, unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, high blood pressure, severe arrhythmia, diabetes, massive active bleeding);
- Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
- According to the investigator's judgment, there are other serious patients who are at risk to the patient's safety or affect the patient's accompanying disease.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04101929
Start Date
October 1 2019
End Date
December 31 2021
Last Update
November 5 2019
Active Locations (1)
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1
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032