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

NCT04713059 | Unknown

• 1 other identifier: CAANGC/EJGC
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• PFS

  01.01.2019 to 01.01.2021

• OS

  01.01.2019 to 01.01.2021

Study Arms (2)

patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT

Genetic: FGFR2

patients with CPS =0 , MSS and TMB < 10Mb/mut

Genetic: FGFR2

Interventions

FGFR2 GENETIC

Mutation of FGFR2

patients with CPS =0 , MSS and TMB < 10Mb/mut; patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Xiaochun Zhang

Qingdao, 266003, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35857405 DERIVED

Central Study Contacts

Man Jiang

CONTACT

+8653282913271; jasmanouc@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Affiliated Hospital of Qingdao University

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2023
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)