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

Study Overview
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Brief Summary
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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).

Official Title
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The Affiliated Hospital of Qingdao University

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

Intervention / Treatment
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* Genetic: FGFR2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT<br> | Genetic: FGFR2<br>* Mutation of FGFR2<br>|
| patients with CPS =0 , MSS and TMB < 10Mb/mut<br> | Genetic: FGFR2<br>* Mutation of FGFR2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR |  | 01.01.2019 to 01.01.2021 | 
| 6m-PFS |  | 01.01.2019 to 01.01.2021 | 
| safety |  | 01.01.2019 to 01.01.2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | 01.01.2019 to 01.01.2021 | 
| OS |  | 01.01.2019 to 01.01.2021 |