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

Gastric Cancer Clinical Trial

Official title:

Anlotinib Plus Toripalimab as First-line Treatment for Patients With Advanced Gastric or Gastro-esophageal Junction Cancer (APICAL-GE): a Single Center, Single-arm Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278222
• Other study ID #: APICAL-GE
• Status: Recruiting
• Phase: Phase 2
• Start date: February 10, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2020
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 factor receptors (PDGFR), and c-kit. Toripalimab is a humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. In the present study, we design a single-arm, single center Phase II trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anlotinib
• Gastric Cancer
• Gastro-oesophageal Junction Cancer
• Immunotherapy
• Stomach Neoplasms
• Toripalimab

Intervention

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

Locations

Country	Name	City	State
China	Department of Medical Oncology, Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Secondary	Progress Free Survival	Time from treatment beginning until disease progression	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks
Secondary	Overall Survival	Time from treatment beginning until death from any cause	From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks
Secondary	Deepness of response	Investigation of depth of response during first-line treatment	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Secondary	Disease control rate	Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Secondary	adverse events	Incidence of Treatment-related adverse Events	Through study completion, an average of 4 weeks