Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT04089657
Eligibility Criteria:
Inclusion Criteria:
* Age between 20-75 years old
* Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma
* Life expectancy of more than 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1
* Have failed for at least 2 lines of chemotherapy
* At least 3 weeks from previous chemotherapy at first dose of trial drug
* 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)
* 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.
* At least one measurable lesion defined by RECIST 1.1 as determined by investigator assessment.
* Has adequate organ function
* At least 4 weeks from any major surgery (at first dose of trial drug)
* Patients must be able to swallow apatinib
Exclusion Criteria:
* 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)
* Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix)
* Less than 4 weeks from the last clinical trial
* Active and uncontrollable bleeding from gastrointestinal tract
* 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
* Hypertension that cannot be controlled by medications (\> 140/90 mmHg despite optimal medical therapy)
* Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
* Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
* Active uncontrolled infection
* Known human immunodeficiency virus (HIV) infection
* Symptomatic central nervous metastasis and/or cancerous meningitis
* Known allergic/hypersensitivity reaction to any of the components of the treatment; or known drug abuse/alcohol abuse
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT04089657
Study Brief:
Protocol Section:
NCT04089657