TQB2450 Plus Anlotinib Combined With Chemotherapy in the Treatment of Gastric or Gastroesophageal… (NCT04891900) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
TQB2450 Plus Anlotinib Combined With Chemotherapy in the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma
China25 participantsStarted 2021-05-10
Plain-language summary
This is a prospective one arm phase II clinical study to evaluate the efficacy and safety of TQB2450 (PD-L1 inhibitor), anlotinib combined with oxaliplatin and capecitabine in patients with unresectable locally advanced, recurrent or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Hemoglobin content (HB) ≥ 90g / L (no blood transfusion within 14 days)
✕. Patients with poor blood pressure control by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); patients with grade II or above myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 480ms); patients with grade III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 50% by NYHA standard.
✕. Active or uncontrolled severe infection.
✕. Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis.
✕. Poor control of diabetes mellitus (FBG \> 10mmol / L).
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: each 2 weeks(Initial treatment) or 3 weeks (maintenance treatment ) up to Progressive Disease（PD） or toxicity intolerable