Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Changzheng Hospital
About this trial
This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.
Eligibility criteria
Qualifiers
Histologically confirmed, UICC stage IV gastric cancer;
no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
at least one measurable lesion;
received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;
Disqualifiers
harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;
dMMR/MSI-H;
Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);
have received anlotinib or other immune checkpoint inhibitor ;
Trial design
Treatments tested in this trial
- Anlotinib Plus Toripalimab
Treatment groups
24 Participants
are divided into 1 treatment groupLocations
1Department of Medical Oncology, Shanghai Changzheng Hospital Shanghai China
Sponsors and collaborators
Shanghai Changzheng Hospital
Lead sponsor
Source ClinicalTrials.gov