Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT
|
Genetic: FGFR2
Mutation of FGFR2
|
| patients with CPS =0 , MSS and TMB < 10Mb/mut
|
Genetic: FGFR2
Mutation of FGFR2
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- PFS [01.01.2019 to 01.01.2021]
- OS [01.01.2019 to 01.01.2021]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiaochun Zhang | Qingdao | China | 266003 |
Sponsors and Collaborators
- The Affiliated Hospital of Qingdao University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAANGC/EJGC