Status:
UNKNOWN
Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy Regimens
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Advanced Metastatic Gastric Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
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
Detailed Description
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 the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04089657
Start Date
December 1 2019
End Date
December 1 2021
Last Update
September 13 2019
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