Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric or Gastro-esophageal Junction Cancer (APICAL-GE)

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric or gastro-oesophageal junction cancer as first-line treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital

Criteria

Inclusion Criteria:

• Histologically confirmed, UICC stage IV gastric or gastro-oesophageal junction 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 0-1;

• 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 Criteria:

• 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