This was a single-center, single-arm, phase II trial. Patients were enrolled from May 2019 to May 2021 at Tianjin Medical University Cancer Institute and Hospital in this study. The key inclusion criteria were:
age of ≥ 18 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0–2;
histologically confirmed metastatic or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma;
previous first-line use of platinum combined with fluorouracil or disease progression within 6 months after withdrawal of adjuvant chemotherapy with platinum and fluorouracil-based regimen, or failure of second-line irinotecan or paclitaxel;
measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
adequate organ and bone marrow function (hemoglobin: ≥90 g/L, neutrophils: ≥1.5 × 109/L, platelets: ≥100 × 109/L, bilirubin: ≤1.5 × upper limit of normal [ULN], alanine aminotransferase [ALT] and aspartate aminotransferase [AST]: ≤2.5 × ULN [if liver metastasis is present, then ALT and AST ≤ 5 × ULN], endogenous creatinine clearance rate: ≥50 mL/min [Cockcroft–Gault formula], routine urinalysis: normal results or urine protein less than (++) or 24-hour protein urine of < 1.0 g, and normal blood coagulation with no active bleeding or thrombosis [international normalized ratio of ≤ 1.5 and activated partial thromboplastin time of ≤ 1.5 × ULN]);
estimated survival time of ≥ 3 months.
The key exclusion criteria included:
previous use of PD-1/PD-L1 inhibitor or other anti-angiogenesis targeted drug;
hypertension that could not be reduced to normal range by antihypertensive drugs;
clearly gastrointestinal bleeding tendency, including locally active ulcer lesions, fecal occult blood (++), or a history of melena and hematemesis within 1 month;
serious cardiovascular and cerebrovascular diseases;
immune system diseases requiring treatment;
inability to swallow or intestinal obstruction;
contraindication or allergy to the study drugs;
concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
The study was approved by the independent ethics committees of Tianjin Medical University Cancer Institute and Hospital and was performed in accordance with the Declaration of Helsinki. All enrolled patients provided written informed consent. This trial was registered with ClinicalTrials.gov, number NCT05025033.
age of ≥ 18 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0–2;
histologically confirmed metastatic or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma;
previous first-line use of platinum combined with fluorouracil or disease progression within 6 months after withdrawal of adjuvant chemotherapy with platinum and fluorouracil-based regimen, or failure of second-line irinotecan or paclitaxel;
measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
adequate organ and bone marrow function (hemoglobin: ≥90 g/L, neutrophils: ≥1.5 × 109/L, platelets: ≥100 × 109/L, bilirubin: ≤1.5 × upper limit of normal [ULN], alanine aminotransferase [ALT] and aspartate aminotransferase [AST]: ≤2.5 × ULN [if liver metastasis is present, then ALT and AST ≤ 5 × ULN], endogenous creatinine clearance rate: ≥50 mL/min [Cockcroft–Gault formula], routine urinalysis: normal results or urine protein less than (++) or 24-hour protein urine of < 1.0 g, and normal blood coagulation with no active bleeding or thrombosis [international normalized ratio of ≤ 1.5 and activated partial thromboplastin time of ≤ 1.5 × ULN]);
estimated survival time of ≥ 3 months.
The key exclusion criteria included:
previous use of PD-1/PD-L1 inhibitor or other anti-angiogenesis targeted drug;
hypertension that could not be reduced to normal range by antihypertensive drugs;
clearly gastrointestinal bleeding tendency, including locally active ulcer lesions, fecal occult blood (++), or a history of melena and hematemesis within 1 month;
serious cardiovascular and cerebrovascular diseases;
immune system diseases requiring treatment;
inability to swallow or intestinal obstruction;
contraindication or allergy to the study drugs;
concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
The study was approved by the independent ethics committees of Tianjin Medical University Cancer Institute and Hospital and was performed in accordance with the Declaration of Helsinki. All enrolled patients provided written informed consent. This trial was registered with ClinicalTrials.gov, number NCT05025033.
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