Status:
RECRUITING
Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Gastric Cancer
Immunotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth fa...
Eligibility Criteria
Inclusion
- 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;
- ECOG performance status 2;
- the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN), ALT and AST \<2.5 × ULN and if liver metastases, BIL \< 3 × ULN, ALT and AST \<5 × ULN; Serum Cr ≤ 1.5 × ULN;
- Patient's written declaration of consent obtained;
- Estimated life expectancy \> 3 months;
Exclusion
- 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 ;
- with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
- severe wounds or surgery 4 weeks before recruitment;
- received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;
- History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively.
- pregnancy or breast feeding;
- absent or restricted legal capacity;
- a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04278222
Start Date
February 10 2020
End Date
December 31 2024
Last Update
July 10 2024
Active Locations (1)
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1
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China