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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma
  • Carcinoma
  • Gastric or Gastro-oesophageal Junction Carcinoma
  • Second-line Therapy

NCT number NCT04713059
Study type Observational
Source The Affiliated Hospital of Qingdao University
Contact Man Jiang
Phone +8653282913271
Email jasmanouc@163.com
Status Recruiting
Phase
Start date January 1, 2020
Completion date January 1, 2023