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出境医 / 临床实验 / Exploratory Clinical Study of Apatinib and PD-1 in Treating Advanced Gastric Cancer

Exploratory Clinical Study of Apatinib and PD-1 in Treating Advanced Gastric Cancer

Study Description
Brief Summary:
The Purpose of This Study is to Evaluate the Efficacy and Safety of Apafitini Combined With PD1 in Patients With Advanced Gastric Cancer After Second-line Treatment Failure, Thus Providing More Options for Patients With Advanced Gastric Cancer.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: Apatinib and PD1 Phase 2

Detailed Description:
Patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: apatinib and PD-1
Every patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effect
Drug: Apatinib and PD1
  1. Apatinib starting dose of 500mg, qd, oral, taken half an hour after a meal
  2. PD-1 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.

Outcome Measures
Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: up to 2 year ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: up to 2 year ]

    Defined as the proportion of patients with a documented complete response, and partial response (CR

    + PR


  2. Disease control rate [ Time Frame: up to 2 year ]
    The time from the start of randomization to the first tumor recurrence/metastasis or the death of the subject for any reason

  3. Overall survival [ Time Frame: up to 2 year ]
    From date of randomization until the date of death from any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
  2. To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed advanced Gastric Cancer.
  3. Failure of the second-line standard treatment regimen (disease progression), >14 days from the last chemotherapy, chemotherapy regimen including fluorouracil (5-FU / capecitabine / teggio), oxaliplatin and irinotecan; Acceptable or not received bevacizumab/cetuximab/regofenib treatment.
  4. Aged 18-70 years old, both genders.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  6. Life expectancy of at least 3 months.
  7. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.If the lesion receiving local therapy (radiotherapy, radiofrequency, interventional therapy, etc.) is the only lesion, definite imaging progress is required.
  8. the main organ functions of the patient shall meet the following standards within 7 days before treatment:Blood routine examination standard (without blood transfusion within 7 days before enrollment)Hemoglobin ≥ 70 g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ PLT)≥80×109/L;Biochemical examination shall meet the following standards:serum total bilirubin (TBIL)≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal(ULN);Serum creatinine (Cr)≤1.5ULN or creatinine removal rate (CCr)≥60ml/min;
  9. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period。

Exclusion Criteria:

  1. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg;
  2. Diabetes blood sugar control is poor;
  3. Acute phase of cerebral infarction, or recovery period <2 months;
  4. Has a variety of factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction);
  5. Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterion;
  6. Coagulation abnormalities (INR>1.5×ULN,APTT>1.5×ULN),with bleeding tendency;
  7. Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation > 1.0 g;
  8. Pregnant or lactating women;
  9. Within 2 weeks after treatment with cytotoxic drugs and radiotherapy;Has taken two or more oral targeted drugs;
  10. Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years;
  11. The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
  12. Patients with severe liver and kidney dysfunction (grade 4) should be excluded;
  13. Those who are allergic to any component of apafitini mesylate should be excluded;
  14. Mental disorders history, or psychotropic drug abuse history;
  15. Previous use of regorafenib is not an exclusion criterion;
  16. According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study;
  17. Surgery was performed within 4 weeks prior to the start of treatment, or patients with major trauma or fractures. Or there is an unhealed wound before treatment;
  18. Patients with severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, or grade III or above (CCS standard) angina, or a history of myocardial infarction within 6 months prior to treatment, or an arrhythmia requiring medication;
  19. The patient has brain metastasis, meningeal metastasis;
  20. Active HBV infection and rejection of formal antiviral therapy;
  21. Active tuberculosis;
  22. Participants who have participated in any drug or medical device clinical trial within 1 month prior to the trial.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ning Li 13526501903 lining97@126.com

Sponsors and Collaborators
Henan Cancer Hospital
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 17, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
Overall survival rate [ Time Frame: up to 2 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Objective response rate [ Time Frame: up to 2 year ]
    Defined as the proportion of patients with a documented complete response, and partial response (CR + PR
  • Disease control rate [ Time Frame: up to 2 year ]
    The time from the start of randomization to the first tumor recurrence/metastasis or the death of the subject for any reason
  • Overall survival [ Time Frame: up to 2 year ]
    From date of randomization until the date of death from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Clinical Study of Apatinib and PD-1 in Treating Advanced Gastric Cancer
Official Title  ICMJE Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer
Brief Summary The Purpose of This Study is to Evaluate the Efficacy and Safety of Apafitini Combined With PD1 in Patients With Advanced Gastric Cancer After Second-line Treatment Failure, Thus Providing More Options for Patients With Advanced Gastric Cancer.
Detailed Description Patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Gastric Cancer
Intervention  ICMJE Drug: Apatinib and PD1
  1. Apatinib starting dose of 500mg, qd, oral, taken half an hour after a meal
  2. PD-1 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.
Study Arms  ICMJE Experimental: apatinib and PD-1
Every patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effect
Intervention: Drug: Apatinib and PD1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
  2. To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed advanced Gastric Cancer.
  3. Failure of the second-line standard treatment regimen (disease progression), >14 days from the last chemotherapy, chemotherapy regimen including fluorouracil (5-FU / capecitabine / teggio), oxaliplatin and irinotecan; Acceptable or not received bevacizumab/cetuximab/regofenib treatment.
  4. Aged 18-70 years old, both genders.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  6. Life expectancy of at least 3 months.
  7. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.If the lesion receiving local therapy (radiotherapy, radiofrequency, interventional therapy, etc.) is the only lesion, definite imaging progress is required.
  8. the main organ functions of the patient shall meet the following standards within 7 days before treatment:Blood routine examination standard (without blood transfusion within 7 days before enrollment)Hemoglobin ≥ 70 g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ PLT)≥80×109/L;Biochemical examination shall meet the following standards:serum total bilirubin (TBIL)≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal(ULN);Serum creatinine (Cr)≤1.5ULN or creatinine removal rate (CCr)≥60ml/min;
  9. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period。

Exclusion Criteria:

  1. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg;
  2. Diabetes blood sugar control is poor;
  3. Acute phase of cerebral infarction, or recovery period <2 months;
  4. Has a variety of factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction);
  5. Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterion;
  6. Coagulation abnormalities (INR>1.5×ULN,APTT>1.5×ULN),with bleeding tendency;
  7. Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation > 1.0 g;
  8. Pregnant or lactating women;
  9. Within 2 weeks after treatment with cytotoxic drugs and radiotherapy;Has taken two or more oral targeted drugs;
  10. Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years;
  11. The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
  12. Patients with severe liver and kidney dysfunction (grade 4) should be excluded;
  13. Those who are allergic to any component of apafitini mesylate should be excluded;
  14. Mental disorders history, or psychotropic drug abuse history;
  15. Previous use of regorafenib is not an exclusion criterion;
  16. According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study;
  17. Surgery was performed within 4 weeks prior to the start of treatment, or patients with major trauma or fractures. Or there is an unhealed wound before treatment;
  18. Patients with severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, or grade III or above (CCS standard) angina, or a history of myocardial infarction within 6 months prior to treatment, or an arrhythmia requiring medication;
  19. The patient has brain metastasis, meningeal metastasis;
  20. Active HBV infection and rejection of formal antiviral therapy;
  21. Active tuberculosis;
  22. Participants who have participated in any drug or medical device clinical trial within 1 month prior to the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954756
Other Study ID Numbers  ICMJE APD-L0315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henan Cancer Hospital
Study Sponsor  ICMJE Henan Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Henan Cancer Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP