NCT04713059

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

The Affiliated Hospital of Qingdao University

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 62 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
GENETIC	FGFR2	Mutation of FGFR2

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-01-01
• Completion: 2023-01-01
• First posted: 2021-01-19
• Last updated: 2021-07-01

Locations

1 site across 1 country: China