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RecruitingPhase 2NCT04278222

Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)

Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial

Sponsor

Shanghai Changzheng Hospital

Enrollment

24 participants

Start Date

Feb 10, 2020

Study Type

INTERVENTIONAL

Conditions

Gastric CancerImmunotherapyToripalimabAnlotinib

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria11

  • 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

Interventions

DRUGAnlotinib Plus Toripalimab

Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w

Locations(1)

Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, China

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NCT04278222

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