Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma Clinical Trial
Official title:
The Affiliated Hospital of Qingdao University
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).
| Status | Recruiting |
| Enrollment | 62 |
| Est. completion date | January 1, 2023 |
| Est. primary completion date | January 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| 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 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Xiaochun Zhang | Qingdao |
| Lead Sponsor | Collaborator |
|---|---|
| The Affiliated Hospital of Qingdao University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ORR | 01.01.2019 to 01.01.2021 | ||
| Primary | 6m-PFS | 01.01.2019 to 01.01.2021 | ||
| Primary | safety | 01.01.2019 to 01.01.2021 | ||
| Secondary | PFS | 01.01.2019 to 01.01.2021 | ||
| Secondary | OS | 01.01.2019 to 01.01.2021 |