Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 11:31 AM
Study NCT ID:
NCT04089657
Status:
UNKNOWN
Last Update Posted:
2019-09-13
First Post:
2019-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C553458', 'term': 'apatinib'}, {'id': 'C000632826', 'term': 'sintilimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-12', 'studyFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease control rate(DCR)', 'timeFrame': '12 months', 'description': 'The percentage of patients who have achieved complete response, partial response and stable disease,evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '12 months', 'description': 'The percentage of patients who achieve complete response or partial response,evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 12 months', 'description': 'Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 12 months', 'description': 'Time from date of first RECIST response to progressive disease \\[PD\\] or death'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'up to 12 months', 'description': 'PFS was calculated from the day of randomization to the date of first documented progression, or death from any cause.'}, {'measure': 'Adverse events（AE）', 'timeFrame': 'up to 12 months', 'description': 'Adverse events assessed using the NCI common toxicity criteria, version 4.01'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Metastatic Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of Apatinib combined with PD-1 antibody Sintilimab for for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer', 'detailedDescription': 'Patients with advanced gastric cancer (AGC) can be treated with multiple lines of chemotherapy. After second-line treatment some patients may receive third- and subsequent lines of chemotherapy if their performance status is well-preserved and they are willing to receive subsequent active treatments. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor approved by the CFDA for the treatment of advanced gastric cancer. In a phase III trial, apatinib significantly improved PFS and OS compared with placebo, but the clinical benefit was modest. As a result of toxicity, 850 mg/day Apatinib may cause dose reduction and delay in some patients ,which also caused some doubts. Therefore, it is a reasonable treatment strategy by reducing the dose and combining it with another low-toxic drug to achieve similar or better effects. Some studies have shown that the combination of targeted therapy and immunotherapy may be effective in solid tumor. Sintilimab (IBI308) is a monoclonal antibody targeting programmed death-1 (PD-1). So, the investigators designed an open-label, single-arm, phase II clinical study to evaluate the efficacy and safety of apatinib combined with Sintilimab in Chemotherapy-Refractory Advanced Metastatic Gastric Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20-75 years old\n* Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma\n* Life expectancy of more than 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1\n* Have failed for at least 2 lines of chemotherapy\n* At least 3 weeks from previous chemotherapy at first dose of trial drug\n* Resolution of all acute toxic side effects of prior therapy or surgical procedures to grade ≤ 1 National Cancer Institute-Common Toxicity Criteria (NCI-CTC) (except for the laboratory values)\n* Failure of prior palliative chemotherapy/chemotherapies (at least one irinotecan- or cisplatin-based). Failure is defined either by progression of disease or by significant toxicity that precludes further treatment.\n* At least one measurable lesion defined by RECIST 1.1 as determined by investigator assessment.\n* Has adequate organ function\n* At least 4 weeks from any major surgery (at first dose of trial drug)\n* Patients must be able to swallow apatinib\n\nExclusion Criteria:\n\n* In the past, participants have received anti PD-1, anti PD-L1 or anti PD-L2 drugs or drugs targeting another stimulation or synergistic inhibition of T cell receptors (such as Cytotoxic T-Lymphocyte Antigen 4 \\[CTLA-4\\] and CD137)\n* Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix)\n* Less than 4 weeks from the last clinical trial\n* Active and uncontrollable bleeding from gastrointestinal tract\n* Known history of QT interval prolongation, ongoing QT prolongation (\\> 450 msec for males or \\> 470 msec for females), any cardiac ventricular dysrhythmias, atrial fibrillation of any grade\n* Hypertension that cannot be controlled by medications (\\> 140/90 mmHg despite optimal medical therapy)\n* Abnormal Coagulation (INR\\>1.5、APTT\\>1.5 UNL), with tendency of bleed;\n* Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);\n* Active uncontrolled infection\n* Known human immunodeficiency virus (HIV) infection\n* Symptomatic central nervous metastasis and/or cancerous meningitis\n* Known allergic/hypersensitivity reaction to any of the components of the treatment; or known drug abuse/alcohol abuse\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT04089657', 'acronym': 'ASGARD', 'briefTitle': 'Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy Regimens', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'Apatinib Plus Sintilimab in Patients With Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'APAICI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apatinib+Sintilimab', 'description': 'Apatinib 500mg qd p.o and Sintilimab 200mg intravenously on day 1 every 3 weeks until disease progression or intolerable toxicity or patients withdrawal of consent', 'interventionNames': ['Drug: Apatinib Mesylate', 'Drug: Sintilimab']}], 'interventions': [{'name': 'Apatinib Mesylate', 'type': 'DRUG', 'otherNames': ['Apatinib'], 'description': 'Apatinib 500mg qd, oral, taken half an hour after a meal', 'armGroupLabels': ['Apatinib+Sintilimab']}, {'name': 'Sintilimab', 'type': 'DRUG', 'otherNames': ['IBI308'], 'description': 'Sintilimab 200mg intravenously on day 1', 'armGroupLabels': ['Apatinib+Sintilimab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nanfeng Fan, MD', 'role': 'CONTACT', 'email': 'Nanfeng_Fan@sina.com', 'phone': '008613705007267'}, {'name': 'JIE LIU, MD', 'role': 'CONTACT', 'email': 'dr2868@sina.com', 'phone': '008613860632919'}], 'overallOfficials': [{'name': 'Nanfeng Fan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fujian Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}