Back to resultsCamrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
Primary Purpose
HER2-positive Gastric Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Sponsored by
About this trial
This is an interventional treatment trial for HER2-positive Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Exclusion Criteria:
- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Sites / Locations
- Shengjing Hospital of China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Arm Description
Camrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14
Outcomes
Primary Outcome Measures
ORR (Objective control rate)
The rate of CR and PR, determined using RECIST v1.1 criteria
Secondary Outcome Measures
DCR (Disease control rate)
The rate of CR, PR plus SD
PFS (Progression-Free survival)
From the date Into this study (signed ICF) to tumor progression or death for any
OS(Overall survival)
Baseline until death from any cause
Full Information
NCT ID
NCT05070598
First Posted
September 27, 2021
Last Updated
September 27, 2021
Sponsor
Shengjing Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05070598
Brief Title
Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
Official Title
A Prospective, Single-arm, Phase II Study of Camrelizumab Combined With Pyrotinib Maleate, Nab-paclitaxel and Tegafur Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Arm Type
Experimental
Arm Description
Camrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14
Intervention Type
Drug
Intervention Name(s)
Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Intervention Description
Camrelizumab was given in the first day of each cycle,Nab-paclitaxel was given in the first day of each cycle, Pyrotinib was given everyday of each cycle, Tegafur given in the day 1-14 of each cycle
Primary Outcome Measure Information:
Title
ORR (Objective control rate)
Description
The rate of CR and PR, determined using RECIST v1.1 criteria
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
DCR (Disease control rate)
Description
The rate of CR, PR plus SD
Time Frame
up to 12 months
Title
PFS (Progression-Free survival)
Description
From the date Into this study (signed ICF) to tumor progression or death for any
Time Frame
up to 12 months
Title
OS(Overall survival)
Description
Baseline until death from any cause
Time Frame
up to approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Exclusion Criteria:
rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Zhang, doctor
Phone
18940253560
Email
zhangnan2515@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Niu, doctor
Phone
18940256668
Email
niun@sj-hospital.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caigang Liu, doctor
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Zhang, doctor
Phone
18940253560
Email
zhangnan2515@163.com
12. IPD Sharing Statement
Learn more about this trial
Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
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