Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)
- Conditions
- Advanced, Relapsed Gastric or Gastro-oesophageal Junction CarcinomaGastric or Gastro-oesophageal Junction CarcinomaSecond-line Therapy
- Interventions
- Genetic: FGFR2
- Registration Number
- NCT04713059
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 62
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT FGFR2 - patients with CPS =0 , MSS and TMB < 10Mb/mut FGFR2 -
- Primary Outcome Measures
Name Time Method 6m-PFS 01.01.2019 to 01.01.2021 ORR 01.01.2019 to 01.01.2021 safety 01.01.2019 to 01.01.2021
- Secondary Outcome Measures
Name Time Method PFS 01.01.2019 to 01.01.2021 OS 01.01.2019 to 01.01.2021
Trial Locations
- Locations (1)
Xiaochun Zhang
🇨🇳Qingdao, China