Gastric or Gastro-oesophageal Junction Carcinoma, Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma, Second-line Therapy
Conditions
Brief summary
Patients were aged \>18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function. The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded. This study was an open, exploratory single-arm, phase II trial. Enrolled patients received anlotinib (12mg, po. qd, d1-14) combined with toripalimab (240 mg, inv, over 30 min once every 2 weeks).
Interventions
Mutation of FGFR2
Sponsors
Study design
Eligibility
Inclusion criteria
Patients were aged \>18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function.
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR | 01.01.2019 to 01.01.2021 |
| 6m-PFS | 01.01.2019 to 01.01.2021 |
| safety | 01.01.2019 to 01.01.2021 |
Secondary
| Measure | Time frame |
|---|---|
| PFS | 01.01.2019 to 01.01.2021 |
| OS | 01.01.2019 to 01.01.2021 |
Countries
China