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Apatinib, Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After AG Regimen

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ClinicalTrials.gov Identifier: NCT04101929
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

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 cancer after chemotherapy with albumin-bound paclitaxel plus gemcitabine regimen

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Apatinib Drug: S-1 capsule Drug: Irinotecan Phase 2

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. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received apatinib, irinotecan and S-1. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.

The efficacy and safety data will be assessed through PFS, OS, ORR and adverse effects as graded by CTC-AE 5.0.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm Study to Evaluate The Safety and Efficacy of Apatinib Combined With Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Albumin-bound Paclitaxel Plus Gemcitabine Regimen
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Apatinib + S-1+ Irinotecan
Apatinib: 250mg po qd; S-1 capsule: According to the body surface area <1.25m2 60mg/d, 1.25 ~ 1.5 m2 80 mg/d, > 1.5m2 100mg/d po bid, taking 7 days, stopping for 7 days, 28 days for 1 cycle; Irinotecan: According to the body surface area of 180 mg/m2, ivgg/90min, once every two weeks.
Drug: Apatinib
Patients receive Apatinib 250mg po qd , Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic.

Drug: S-1 capsule
Patients receive S-1 capsule According to the body surface area <1.25m2 60mg/d, 1.25 ~ 1.5 m2 80 mg/d, > 1.5m2 100mg/d po bid, taking 7 days, stopping for 7 days, 28 days for 1 cycle, Treatment repeats until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic.

Drug: Irinotecan

Patients receive Irinotecan According to the body surface area of 180 mg/m2, ivgg/90min, once every two weeks. Continuous chemotherapy until the criteria for discontinuation of the drug are met (eg, progression of the disease, intolerance of adverse reactions, or withdrawal of informed consent by the patient).

Because the toxicity of apatinib or irinotecan or tigeol in the chemotherapy regimen meets the withdrawal criteria, the drug can be discontinued alone and the exact duration of the trial treatment recorded.





Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: through study completion, an average of 1 year ]
    To investigate the progression-free survival (PFS) of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS)


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the overall survival of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS).

  2. Incidence of Adverse Events [ Time Frame: through study completion, an average of 1 year ]
    Adverse events of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS).

  3. Overall Response Rate [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the overall response rate of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Blood routine examination criteria must be met: (no blood transfusion within 14 days)

      1. HB≥90g/L;
      2. ANC≥1.5×109/L;
      3. PLT≥80×109/L
    2. Biochemical tests are subject to the following criteria:

      1. BIL <1.25xULN ;
      2. ALT and AST<2.5ULN;
      3. 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101929


Contacts
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Contact: Xian-Jun Yu +86 21 6417559 yuxianjun@fudanpci.org

Locations
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China, Shanghai
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xian-Jun Yu, M.D., Ph.D.    +86-21-6417-5590    yuxianjun@fudanpci.org   
Contact: Wen-Quan Wang, M.D., Ph.D.    +86-21-6417-5590    wangwenquan@fudanpci.org   
Principal Investigator: Xianjun Yu, M.D., Ph.D.         
Sponsors and Collaborators
Fudan University
Investigators
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Study Director: Xian-Jun Yu Fudan University

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Responsible Party: Xian-Jun Yu, Prinicipal Investigator, Clinical Professor, Fudan University
ClinicalTrials.gov Identifier: NCT04101929     History of Changes
Other Study ID Numbers: CSPAC-25
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xian-Jun Yu, Fudan University:
metastatic pancreatic cancer
pancreatic adenocarcinoma
apatinib
S-1
irinotecan
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Irinotecan
Apatinib
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors