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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04713059
Enrollment
62
Registered
2021-01-19
Start date
2020-01-01
Completion date
2023-01-01
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

GENETICFGFR2

Mutation of FGFR2

Sponsors

The Affiliated Hospital of Qingdao University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
ORR01.01.2019 to 01.01.2021
6m-PFS01.01.2019 to 01.01.2021
safety01.01.2019 to 01.01.2021

Secondary

MeasureTime frame
PFS01.01.2019 to 01.01.2021
OS01.01.2019 to 01.01.2021

Countries

China

Contacts

Primary ContactMan Jiang
jasmanouc@163.com+8653282913271

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026