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

Primary Purpose

Gastric Cancer, Gastro-oesophageal Junction Cancer, Immunotherapy

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib Plus Toripalimab

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Medical Oncology, Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anlotinib Plus Toripalimab

Arm Description

the combination of Anlotinib Plus Toripalimab as first-line treatment

Outcomes

Primary Outcome Measures

objective response rate

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Secondary Outcome Measures

Progress Free Survival

Time from treatment beginning until disease progression

Overall Survival

Time from treatment beginning until death from any cause

Deepness of response

Investigation of depth of response during first-line treatment

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

adverse events

Incidence of Treatment-related adverse Events

Full Information

NCT ID

NCT04278222

First Posted

February 19, 2020

Last Updated

December 28, 2020

Sponsor

Shanghai Changzheng Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04278222

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 10, 2020 (Actual)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Changzheng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Gastro-oesophageal Junction Cancer, Immunotherapy, Anlotinib, Toripalimab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anlotinib Plus Toripalimab

Arm Type

Experimental

Arm Description

the combination of Anlotinib Plus Toripalimab as first-line treatment

Intervention Type

Drug

Intervention Name(s)

Anlotinib Plus Toripalimab

Intervention Description

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

Primary Outcome Measure Information:

Title

objective response rate

Description

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Time Frame

Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Secondary Outcome Measure Information:

Title

Progress Free Survival

Description

Time from treatment beginning until disease progression

Time Frame

Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks

Title

Overall Survival

Description

Time from treatment beginning until death from any cause

Time Frame

From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks

Title

Deepness of response

Description

Investigation of depth of response during first-line treatment

Time Frame

Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Title

Disease control rate

Description

Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease

Time Frame

Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Title

adverse events

Description

Incidence of Treatment-related adverse Events

Time Frame

Through study completion, an average of 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Department of Medical Oncology, Shanghai Changzheng Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ke Liu

Phone

+86-18502113721

45352126@qq.com

First Name & Middle Initial & Last Name & Degree

Yuan-Sheng Zang

12. IPD Sharing Statement

Citations:

PubMed Identifier

35623069

Citation

Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

Results Reference

derived

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

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