Clinical trial · Observational
Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)
The Affiliated Hospital of Qingdao University
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma | — | UNRESOLVED | — |
| Gastric or Gastro-oesophageal Junction Carcinoma | — | UNRESOLVED | — |
| Second-line Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FGFR2 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT
- interventionNames
- Genetic: FGFR2
- label
- patients with CPS =0 , MSS and TMB < 10Mb/mut
- interventionNames
- Genetic: FGFR2
Primary outcomes (3)
- measure
- ORR
- timeFrame
- 01.01.2019 to 01.01.2021
- measure
- 6m-PFS
- timeFrame
- 01.01.2019 to 01.01.2021
- measure
- safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJiang 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