Toripalimab Combined With Anlotinib for Patients With Advanced Relapsed or Refractory Gastric or Esophagogastric Junction Cancer (EGJC)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    62
  • sponsor
    The Affiliated Hospital of Qingdao University
Updated on 11 July 2021

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).

Details
Condition Gastric or Gastro-oesophageal Junction Carcinoma, GC/EGJC, second-line therapy, second line therapy, Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma, Refractory to the First Line of Therapy
Treatment ARID1A, ARID1A, FGFR2, FGFR2
Clinical Study IdentifierNCT04713059
SponsorThe Affiliated Hospital of Qingdao University
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

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
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