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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278222
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Yuan-Sheng Zang, Shanghai Changzheng Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastro-oesophageal Junction Cancer Immunotherapy Anlotinib Toripalimab Drug: Anlotinib Plus Toripalimab Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anlotinib Plus Toripalimab
the combination of Anlotinib Plus Toripalimab as first-line treatment
Drug: Anlotinib Plus Toripalimab
Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w




Primary Outcome Measures :
  1. objective response rate [ Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks ]
    Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission


Secondary Outcome Measures :
  1. Progress Free Survival [ Time Frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks ]
    Time from treatment beginning until disease progression

  2. Overall Survival [ Time Frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks ]
    Time from treatment beginning until death from any cause

  3. Deepness of response [ Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks ]
    Investigation of depth of response during first-line treatment

  4. Disease control rate [ Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks ]
    Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease

  5. adverse events [ Time Frame: Through study completion, an average of 4 weeks ]
    Incidence of Treatment-related adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278222


Locations
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China
Department of Medical Oncology, Shanghai Changzheng Hospital Recruiting
Shanghai, China
Contact: Ke Liu    +86-18502113721    45352126@qq.com   
Principal Investigator: Yuan-Sheng Zang         
Sponsors and Collaborators
Shanghai Changzheng Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuan-Sheng Zang, Director, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT04278222    
Other Study ID Numbers: APICAL-GE
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases