Combination of Anlotinib and Toripalimab for Advanced Gastric Cancer

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

This study is testing a new combination of two drugs, Anlotinib and Toripalimab, to see if they can help people with advanced gastric cancer who haven't had treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Changzheng Hospital (Academic / other)
• Drugs / interventions: anlotinib, chemotherapy, prednisone, Toripalimab
• Locations: 1 site (Shanghai)
• Trial ID: NCT04278222 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Anlotinib, a tyrosine kinase inhibitor, combined with Toripalimab, an immunotherapy agent, as a first-line treatment for patients with advanced gastric cancer and an ECOG performance status of 2. It is a single-arm, single-center Phase II trial conducted at Shanghai Changzheng Hospital. The trial aims to determine how well this combination works in treating patients who have not received prior systemic anti-cancer treatment.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed stage IV gastric cancer, ECOG performance status of 2, and no prior systemic anti-cancer treatment.

Not a fit: Patients with HER2 positive gastric cancer or those with dMMR/MSI-H are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced gastric cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar combinations of targeted therapies and immunotherapies in various cancers, suggesting potential for success in this approach.

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

Where this trial is running

Shanghai

• Department of Medical Oncology, Shanghai Changzheng Hospital — Shanghai, China (Recruiting)

Conditions Gastric Cancer; Immunotherapy; Anlotinib; Toripalimab