Clinical trial · Interventional
Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy Regimens
Apatinib Plus Sintilimab in Patients With Advanced Gastric Cancer
NCT04089657CI-TRIAL-00040611ASGARDunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib Mesylate | Drug | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- 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.
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.