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Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067986
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zhongshan Hospital Xiamen University

Brief Summary:
The efficacy and safety of the use of Camrelizumab combined with Apatinib

Condition or disease Intervention/treatment Phase
Colorectal Cancer Recurrent Drug: Camrelizumab Drug: Apatinib Phase 1 Phase 2

Detailed Description:

To evaluate the clinical efficacy and safety of Camrelizumab combined with Apatinib in the treatment of patients with advanced gastric cancer and colorectal cancer.

The 62 patients were enrolled in a 2-week regimen with 200mg Camrelizumab given intravenously every two weeks and 250mg apatinib mesylate every 4 weeks for a treatment cycle until progressive or intolerable,then the objective remission rate(ORR) was calculated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer:One-arm Exploratory Clinical Trial
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Camrelizumab + Apatinib
Camrelizumab + Apatinib
Drug: Camrelizumab

Camrelizumab One course will last 28 days.Intravenous injection at a dose of 200 mg, q2w

One course will last 28 days. Oral administration at a dose of 250 mg/d

Other Name: Apatinib

Drug: Apatinib
Apatinib One course will last 28 days.Oral administration at a dose of 250 mg, qd




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: one year ]
    Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse-Events [ Time Frame: one year ]
    Incidence of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Age 18 - 75 years;
  • Patients with histologically or cytologically confirmed advanced or metastatic gastric cancer and colorectal cancer.
  • Patients who had previously progressed after receiving standard second-line advanced treatment;
  • Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 (CT scan length and diameter of tumor lesion≥10mm,CT scan of lymph node lesion was short diameter≥15mm,scan slice thickness 5mm;)
  • ECOG performance status (PS) 0 - 2;
  • Life expectancy of at least 3 months;
  • Patients with adequate organ function at the time of enrollment as defined below:

    1. Blood routine examination standard:(without blood transfusion within 14 days before enrollment)

      1. Hb ≥90g/L,
      2. WBC≥3.0×109/L
      3. ANC ≥ 1.5×109/L,
      4. PLT ≥ 80×109/L;
    2. Biochemical examination shall meet the following standards:

      1. BIL <1.5 times the upper limit of normal(ULN),
      2. ALT and aspartate aminotransferase (AST) <2.5×upper limit of normal (ULN),If liver metastasis is present,ALT and AST<5ULN GPT≤1.5×ULN;
      3. Serum creatinine Cr≤1ULN,Serum creatinine >50ml/min(Cockcroft-Gault math)
  • Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients,and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study; males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period
  • Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;

Exclusion Criteria:

  • Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years;
  • Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy <2 weeks before enrollment;
  • With severe heart, liver, lung and kidney disease;Significant neurological or psychiatric disorders;Patients with partial or complete gastrointestinal obstruction;
  • Patients with a large amount of pleural effusion or ascites requiring drainage;
  • Patients with symptomatic brain metastasis;
  • Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents; Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment;Patients with acute coronary syndrome(included QTc male>450ms,female>470ms)and cardiac dysfunction;
  • Women who are pregnant or breastfeeding;
  • Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease;
  • Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease: included HIV positive or a history of organ transplantation and allogeneic bone marrow transplantation;
  • Patients with interstitial lung disease with symptoms or signs of activity;
  • 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;Coagulation abnormalities (INR>1.5、APTT>1.5ULN);
  • Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation;
  • Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture;
  • Patients with a seizure disorder who require pharmacotherapy;
  • Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients;
  • 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;
  • participated in other clinical studies before and during treatment;

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): NCT04067986


Contacts
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Contact: Li Xiao, Doctor 2292201 ext 0592 xiaolibohan@163.com

Locations
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China, Fujian
Zhongshan Hospital Affiliated to Xiamen University Recruiting
Xiamen, Fujian, China, 361000
Contact: Shuntian Cai    +86 18030190632    nktianxingjian@163.com   
Sponsors and Collaborators
Zhongshan Hospital Xiamen University
Investigators
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Principal Investigator: Li Xiao, Doctor Zhongshan Hospital Xiamen University
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Responsible Party: Zhongshan Hospital Xiamen University
ClinicalTrials.gov Identifier: NCT04067986    
Other Study ID Numbers: ZhongshanHXU
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: August 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
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action