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

Launched by SHANGHAI CHANGZHENG HOSPITAL · Feb 19, 2020

Keywords

ClinConnect Summary

The APICAL-GC clinical trial is studying a new treatment approach for patients with advanced gastric cancer, specifically those with a performance status of ECOG 2, which means they may have some limitations in their daily activities but are still able to care for themselves. The trial is testing a combination of two medications, Anlotinib and Toripalimab, to see if they are effective and safe as a first treatment option for this type of cancer. To participate, patients need to have confirmed stage IV gastric cancer, not have received prior cancer treatments, and have at least one measurable tumor. They also need to meet specific health criteria, such as having adequate organ function and a life expectancy of more than three months.

If you or a loved one qualifies for this trial, you can expect to receive either the new combination treatment or standard care. Participants will be closely monitored for any side effects and how well the treatment is working. This trial is currently recruiting participants aged 65 to 74, and both men and women are eligible. It’s important to note that some patients may not qualify due to other health issues or prior treatments, so discussing eligibility with a healthcare provider is crucial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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