Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
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
1 other identifier
interventional
35
1 country
1
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.);
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2021
CompletedFirst Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedOctober 7, 2021
September 1, 2021
2 years
September 27, 2021
September 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
ORR (Objective control rate)
The rate of CR and PR, determined using RECIST v1.1 criteria
up to 12 months
Secondary Outcomes (3)
DCR (Disease control rate)
up to 12 months
PFS (Progression-Free survival)
up to 12 months
OS(Overall survival)
up to approximately 24 months
Study Arms (1)
Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
EXPERIMENTALCamrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14
Interventions
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
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shengjing Hospital of China Medical University
Shenyang, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Caigang Liu, doctor
Shengjing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 7, 2021
Study Start
September 7, 2021
Primary Completion
September 1, 2023
Study Completion
March 30, 2024
Last Updated
October 7, 2021
Record last verified: 2021-09