Clinical trial NCT04713059: Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)
Official title: The Affiliated Hospital of Qingdao University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric or Gastro-oesophageal Junction Carcinoma
Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma
Second-line Therapy
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were aged \>18 years with histological confirmed GC/EGJC and were refractory to the first line of 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).


Eligibility criteria: 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.

Primary outcomes:
measure: ORR
timeFrame: 01.01.2019 to 01.01.2021
measure: 6m-PFS
timeFrame: 01.01.2019 to 01.01.2021
measure: safety
timeFrame: 01.01.2019 to 01.01.2021
Secondary outcomes:
measure: PFS
timeFrame: 01.01.2019 to 01.01.2021
measure: OS
timeFrame: 01.01.2019 to 01.01.2021
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Xiaochun Zhang
Study officials:
References:
citation: Jiang M, Zhang C, Hu Y, Li T, Yang G, Wang G, Zhu J, Shao C, Hou H, Zhou N, Liu K, Zhang X. Anlotinib Combined with Toripalimab as Second-Line Therapy for Advanced, Relapsed Gastric or Gastroesophageal Junction Carcinoma. Oncologist. 2022 Nov 3;27(11):e856-e869. doi: 10.1093/oncolo/oyac136.